[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bronchopulmonary-dysplasia-bpd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bronchopulmonary-dysplasia-bpd":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,55,89,116,148,190,215,242,278,301,323,347,402,429,459,485,520],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100601384","national-surveillance-and-prevention-of-neonatal-vap-100601384",false,"NCT07109791","National Surveillance and Prevention of Neonatal VAP","Developing a National Approach to Surveillance and Prevention for Neonatal Ventilator-Associated Pneumonia","INCLUSION CRITERIA:\n\n* All VLBW infants admitted to participating tertiary NICUs in Canada\n* All neonatal VAP events diagnosed based on the physicians' discretion\n\nEXCLUSION CRITERIA:\n\n* Infants with major congenital anomalies\n* Infants with moribund status on admission","ALL","24 Weeks",{"count":19,"type":20},1500,"ESTIMATED","6 Months","OBSERVATIONAL","The goal of this observational study is to improve how hospital-acquired lung infections (called ventilator-associated pneumonia, or VAP) are diagnosed, treated and prevented in very low birth weight (VLBW) infants, babies born very early (preterm) or very small who often require respiratory support in hospital's neonatal intensive care units (NICUs).\n\nThe main questions it aims to answer are:\n\n* How often do very-low-birth-weight (VLBW) infants get ventilator-associated pneumonia (VAP) in hospitals across Canada?\n* How often are these VAP infections caused by germs that are resistant to antimicrobials (also known as antimicrobial-resistant organisms or AROs)?\n* What types of antimicrobial-resistant germs (AROs) are causing them?\n* How are these infections being treated with antibiotics, and can we reduce unnecessary antibiotic use?\n* Which diagnostic definition is the best and most accurate for diagnosing VAP in newborns, based on real patient data and expert agreement?\n* Can we use this information to create clear, evidence-based guidelines that help hospitals prevent and treat VAP in the same, effective way?\n\nResearchers will compare how different hospitals define, report, and manage VAP to devise a shared, evidence-based approach that will lead to more accurate diagnoses and better treatment and outcomes for neonatal VAP.\n\nResearchers will:\n\n* Use data already collected in hospital records (per existing standard of clinical care).\n* Analyse how often VAP occurs, how it is diagnosed, and how it is treated\n* Work with experts and hospitals to develop and implement a standard, evidence-based plan for diagnosing, managing and preventing VAP in newborns\n\nThe overarching goal is to create a clear, nationwide approach to ensure hospitals across Canada care for preterm babies in a standardized manner, reduce infection rates, avoid unnecessary antibiotic use, and improve outcomes for these vulnerable infants.",[25,26,27,28],"Ventilator-Associated Pneumonia (VAP), Neonatal","Bronchopulmonary Dysplasia (BPD)","Antibiotic-Resistant Organisms (AROs)","Health-Care Associated Infection (HAI)",[30,31,32,33,34,35,36,37,38,39,40,41],"Preterm","Neonate","Neonatal intensive care unit (NICU)","Ventilator-Associated Pneumonia (VAP)","Healthcare-associated infections (HAI)","Invasive mechanical ventilation (IMV)","Bronchopulmonary dysplasia (BPD)","Antibiotic-resistant organisms (AROs)","Antimicrobial stewardship","Implementation science","Quality improvement (QI)","Infection surveillance","NOT_YET_RECRUITING","2026-06-24",{"date":45,"type":46},"2026-06-25","ACTUAL",{"date":48,"type":20},"2026-10-01",{"date":50,"type":20},"2029-09",{"name":52,"class":53},"University of Alberta","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":54},"100641602","phase-4-enteral-lipid-supplementation-and-bronchoplumonary-dysplasia-of-premature-infants-100641602","NCT07652684","Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants","Enteral Lipid Supplementation and Bronchoplumonary Dysplasia of Premature Infants: A Randomized Controlled Trial (The PRELUDE Trial)","PRELUDE","Inclusion Criteria:\n\nInfants born at Papageorgiou Hospital in Neonatology Department and NICU of Aristotle University of Thessaloniki with GA equal to or less than 29 weeks are eligible to participate in the study.\n\nExclusion Criteria:\n\nCongenital malformations, chromosomal abnormalities or critical illness with short life expectancy.\n\nStudy participation requires written informed parental consent within 48h after birth.","29 Weeks",{"count":65,"type":20},74,"INTERVENTIONAL",[68],"PHASE4","The Impact of Omega-3 (DHA - Docosahexaenoic Acid) and Omega-6 (ARA - Arachidonic Acid) Supplementation on the Development of Bronchopulmonary Dysplasia in Extremely and Very Preterm Infants (24-29 weeks of gestational age).",[26],[72,73,74,75,76,77,78],"BPD","preterm infant","nutrition","ARA","DHA","respiratory support","prematurity","RECRUITING","2026-06-11",{"date":82,"type":46},"2026-06-17",{"date":84,"type":46},"2025-03-04",{"date":86,"type":20},"2027-03-01",{"name":88,"class":53},"Aristotle University Of Thessaloniki",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":66,"phases":100,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100625013","continued-pressure-for-alveolar-protection-cpap-trial-100625013","NCT07417111","Continued Pressure for Alveolar Protection (CPAP Trial)","Continued Pressure for Alveolar Protection: A Randomized Controlled Trial (CPAP Trial)","CPAP","Inclusion Criteria:\n\n* Gestational age \\\u003C29 weeks at birth\n* PMA \\\u003C32 weeks at study entry\n* On treatment with CPAP without a rate in FiO2 \\\u003C0.25 and PEEP of 4-5 cmH2O\n* Meet stability criteria:\n* If previously intubated must be extubated ≥ 72 hours\n* \\\u003C3 self-resolving apneas (≤ 20 s) and\u002For bradycardia (\\\u003C100 bpm) in any hour over previous 6 hours\n* No episodes of apnea or bradycardia requiring intervention (oxygen\u002Fstimulation\u002Fbag and mask) for 24 hours\n* Parents\u002Flegal guardians consent for enrollment\n\nExclusion Criteria:\n\n* Major malformation\n* Neuromuscular condition that affects respiration\n* Terminal illness\n* Decision to withhold or limit support\n* Too sick to participate in opinion of Attending physician\n* Clinical shock, sepsis\n* Planned surgery during study period","31 Weeks",{"count":99,"type":20},860,[101],"NA","The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at 36 weeks' PMA.",[26],[105,95],"Continuous Positive Airway Pressure","2026-06-01",{"date":108,"type":46},"2026-06-02",{"date":110,"type":20},"2026-11-05",{"date":112,"type":20},"2029-01-30",{"name":114,"class":115},"NICHD Neonatal Research Network","NETWORK",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":66,"phases":128,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100600757","phase-1-pk-safety-and-preliminary-efficacy-study-of-montelukast-in-critically-ill-infants-with-developing-bronchopulmonary-dysplasia-100600757","NCT07101640","PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia","Pharmacokinetics, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia","PRISM","Inclusion Criteria\n\n1. Documented informed consent from parent or guardian, prior to study activities\n2. Receiving mechanical ventilation \\[high frequency or conventional\\] and requiring supplemental oxygen (FiO2 ≥ 30%) at time of randomization\n3. \\\u003C28 weeks' gestational age and \\\u003C1000 g bodyweight at birth\n4. 7 to 28 (inclusive) days postnatal age at the time of first study drug dose\n5. Able to tolerate 5 mL of enteral volume\n\nExclusion Criteria\n\n1. Previous enrollment and dosing in the current PRISM study (NICHD-2023-MON01)\n2. Previous exposure to montelukast within 7 days prior to randomization\n3. Known allergy to montelukast\n4. PI deems infant - prior to enrollment - is not expected to survive\n5. Has a disease complication that would preclude safe participation of the participant\n6. Increased respiratory support due to intercurrent illness (e.g., sepsis, necrotizing enterocolitis, etc.). Infants should be excluded from the study until after resolution of the acute event\n7. Congenital lung and diaphragmatic malformations","7 Days","28 Days",{"count":127,"type":20},28,[129,130],"PHASE1","PHASE2","The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the bloodstream, and how quickly it is removed from the bloodstream.\n\nData supporting the prospect of montelukast benefit involved 6 previous studies involving 206 preterm infants. The dosing ranged from 0.5 to 2.5 mg\u002Fkg\u002Fday, which aligns with the proposed initial dose of 0.75 mg\u002Fkg\u002Fday. Though each previous study had a small population, collectively they reveal montelukast as a promising drug in populations of preterm infants developing BPD and for individual preterm infants who are \"developing BPD.\" Thus, researchers expect clinical benefit for preterm infants in this study.\n\nDespite the benefit-to-risk ratio presented by these previous studies, the optimal dose remains to be determined; thus, this study design and PK analysis will start with the lowest dose that is likely to provide direct benefit to participants.",[26,133,134],"Premature Births","Critical Illness",[136,137,138,139],"PK","Pharmacokinetics","bronchopulmonary dysplasia","montelukast",{"date":108,"type":46},{"date":142,"type":46},"2026-02-23",{"date":144,"type":20},"2028-06-30",{"name":146,"class":53},"Duke University",5,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":66,"phases":159,"briefSummary":160,"conditions":161,"keywords":170,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":54},"100631599","heterologous-cord-blood-derived-red-blood-cell-for-transfusion-in-extremely-preterm-infants-100631599","NCT07502781","Heterologous Cord Blood-Derived Red Blood Cell for Transfusion in Extremely Preterm Infants","Multicenter, Randomized, Double-Blind Pilot Clinical Trial Evaluating the Impact of Transfusion With Heterologous Cord Blood-Derived Red Blood Cells Versus Adult Red Blood Cells in Extremely Premature Infants","Inclusion Criteria:\n\n* Signed informed consent obtained from parents or legal guardians.\n* Gestational age at birth \\\u003C 28 weeks or birth weight \\\u003C 1000 g.\n* Admission to one of the participating neonatal intensive care units (NICUs) in the Barcelona area.\n\nExclusion Criteria:\n\n* Prior red blood cell transfusion during the fetal or neonatal period.\n* Maternal-fetal immunization (e.g., isoimmunization).\n* Fetal hydrops.\n* Major congenital malformations.\n* Congenital infections.\n* Immediate need for blood before randomization (e.g., hemorrhagic shock, consumptive coagulopathy).\n* Participation in another clinical trial that could interfere with the primary outcome.","23 Weeks","28 Weeks",{"count":158,"type":20},176,[101],"Anemia is a condition in which there are not enough red blood cells to carry oxygen throughout the body. It is very common in extremely preterm infants (born before 28 weeks of pregnancy), and many of these babies require red blood cell transfusions during their hospital stay.\n\nCurrently, transfusions are given using red blood cells donated by adults. An alternative option is to use red blood cells collected from umbilical cord blood, which may be more similar to a newborn's own blood. This approach has been used in some neonatal units with encouraging results and no reported safety concerns.\n\nThis study aims to determine whether transfusion with umbilical cord blood improves clinical outcomes and reduces potential side effects compared to standard adult donor blood transfusion in extremely preterm infants. We hypothesize that umbilical cord blood transfusion will be at least as safe as adult donor blood and may provide clinical benefits.\n\nAbout 115 extremely preterm infants admitted to neonatal units in Catalonia will participate. If parents agree, their baby will be randomly assigned to receive either compatible umbilical cord blood or compatible adult donor blood if a transfusion becomes necessary. Babies will only receive a transfusion if they clinically need one. If cord blood is not available at the time of transfusion, the baby will receive compatible adult donor blood regardless of the assigned group.\n\nTo evaluate the response to treatment, small blood samples will be collected at birth, at one month of life, and 24 hours after any transfusion. These samples are taken at the same times as routine blood tests, so participation does not require additional needle sticks. The amount of blood collected is minimal (about 0.2 mL per sample).\n\nIn addition, a painless and non-invasive sensor will be placed on the baby's head for 24 hours to measure oxygen delivery to the brain. Urine samples will also be collected before and after transfusion to help assess how oxygen reaches body tissues.\n\nParticipation will continue until the baby reaches 36 weeks of postmenstrual age or is discharged from the hospital, whichever comes first.",[162,163,164,165,166,26,167,168,169],"Extremely Premature Infant","Anemia Neonatal","Blood Transfusion","Umbilical Cord Blood","Fetal Hemoglobin","Retinopathy of Prematurity (ROP)","Death; Neonatal","Intensive Care Units, Neonatal",[171,172,173,174,175,176,177,178,179,180],"Cord blood red blod cell transfusion","Umbilical cord blood transfusion","Extremely preterm infants","Neonatal anemia","Fetal hemoglobin","Adult donor red blood cells","Bronchopulmonary dysplasia","Retinopathy of prematurity","Oxygen delivery","Days requiring oxygen supplementation","2026-03-27",{"date":183,"type":46},"2026-03-31",{"date":185,"type":20},"2027-01",{"date":187,"type":20},"2029-12",{"name":189,"class":53},"Hospital Clinic of Barcelona",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":4},"100630406","impact-of-the-early-life-virome-development-on-bronchopulmonary-dysplasia-in-preterm-neonates-100630406","NCT07487259","Impact of the Early Life Virome Development on Bronchopulmonary Dysplasia in Preterm Neonates","ELVIRE","Inclusion Criteria:\n\n* Birth \\\u003C 30 SA\n* Respiratory support at birth (invasive or non-invasive ventilation, or oxygen supplementation).\n\nExclusion Criteria:\n\n* \\- Major congenital anomalies of the lung or airways.\n* Death, transfer or discharge before 36 weeks' postmenstrual age (PMA) (not allowing progression to BPD to be known).\n* Number of respiratory samples collected \\\u003C 3","30 Weeks",{"count":199,"type":20},40,"Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity. The pathophysiology of BPD is multifactorial, involving inflammation and oxidative stress due to neonatal exposures such as mechanical ventilation and infections.\n\nPrevious studies have highlighted the role of respiratory bacterial microbiota in BPD development, with causal effects having been demonstrated in murine models. Moreover, the gut-lung axis is implicated in BPD, with alterations to the gut bacteriome and mycobiome observed in preterm infants in the first weeks of life who later develop BPD.\n\nDespite its critical role in shaping immunity and microbial ecology, the virome has been largely understudied in preterm infants. Our recent observations have revealed the existence of a detectable respiratory virome at birth in most very preterm infants, and certain virome and bacteriome profiles have been found to be associated with different risks of developing BPD.\n\nHypothesis:\n\nThe early acquisition and dynamics of the respiratory and gut virome in the first weeks of life influence microbiome structure and pulmonary immune development, contributing to BPD pathogenesis. These dynamics may define distinct endotypes of BPD with implications for prognosis and therapy.\n\nObjectives:\n\n* Primary: Characterize the evolution of the respiratory and gut virome during the first 3 weeks of life in infants born \\\u003C30 weeks of gestation, comparing those who develop BPD to those who do not.\n* Secondary:\n\n  * Define different BPD endotypes and assess their association with demographic and clinical characteristics\n  * Characterise the structure of the microbiome within each endotype.\n  * Compare the evolution of the virome, bacteriome and mycobiome within and between anatomical sites.\n\nStudy Design:\n\nA monocentric, prospective observational cohort of 40 preterm infants (\\\u003C30 weeks GA) requiring respiratory support at birth. Infants are classified at 36 weeks' postmenstrual age (PMA) into BPD and non-BPD groups based on oxygen dependency.\n\nSample Collection:\n\n* Oropharyngeal aspirates: Collected at days 0, 7, 14, and 21.\n* Stool samples: Collected at days 7, 14, and 21.\n\nMethods:\n\n* Virome analysis: Viral metagenomics\n* Metatranscriptomics: Assess transcriptionally active bacteria\u002Ffungi and host gene expression.\n* Data integration: Multi-omics factor analysis and unsupervised clustering to identify BPD endotypes; ecological network analysis to evaluate microbiome structure and interactions.\n\nOutcomes:\n\n* Primary: Qualitative and quantitative assessment of virome composition and diversity, including dynamics and persistence across timepoints.\n* Secondary: Definition of microbiome-based endotypes; interaction networks between viruses, bacteria, and fungi; and longitudinal comparisons of microbial diversity and composition across anatomical sites.",[26],[177,203,204,205],"Microbiome","Virome","Premature neonates","2026-03-17",{"date":208,"type":46},"2026-03-23",{"date":210,"type":20},"2026-04-01",{"date":212,"type":20},"2028-07-01",{"name":214,"class":53},"Hospices Civils de Lyon",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":156,"enrollmentInfo":222,"targetDuration":4,"studyType":66,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":54},"100627369","phase-2-can-betamethasone-given-after-birth-help-extremely-premature-babies-come-off-breathing-support-safely-and-effectively-100627369","NCT07447739","Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?","Efficacy and Safety of Postnatal Betamethasone for Respiratory Weaning in Extremely Low Gestational Age Neonates (ELGANs) in a Prospective Cohort - Proof of Concept Pilot Study","Inclusion Criteria:\n\n* Infants born at less than 28 weeks gestation age\n* Admitted to WMC NICU prior to day of life 35\n\nExclusion Criteria:\n\n* Infants with major congenital or chromosomal abnormalities.\n* Death prior to DOL 8.\n* Previous exposure to postnatal steroids",{"count":223,"type":20},100,[130],"The goal of this study is to determine if giving a steroid medication (specifically, betamethasone) after birth can help extremely premature babies (born before 28 weeks) come off breathing machines safely and reduce their risk of chronic lung disease associated with prematurity. Only babies who meet treatment criteria will receive this medication. Babies who do not meet treatment criteria will not receive medication.\n\nThe main questions it aims to answer are:\n\n* Does betamethasone make it easier for babies to come off a breathing machine?\n* Does betamethasone cause any harmful side effects on growth or development?\n\nAll babies in this study will:\n\n* Receive standard NICU care, with or without betamethasone\n* Have their progress, growth, and development followed over time",[227,26],"Respiratory Distress Syndrome (RDS)",[229,138,230,231,232],"respiratory distress syndrome","extremely low gestational age neonates","postnatal corticosteroids","betamethasone","2026-02-26",{"date":235,"type":46},"2026-03-03",{"date":237,"type":20},"2026-04",{"date":239,"type":20},"2029-03",{"name":241,"class":53},"Khang Nguyen",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":249,"maxAge":250,"enrollmentInfo":251,"targetDuration":250,"studyType":22,"phases":4,"briefSummary":253,"conditions":254,"keywords":262,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":54},"100613980","characterization-of-extracellular-vesicles-from-the-cord-blood-of-extremely-preterm-new-borns-and-their-correlation-with-severe-morbidity-and-mortality-100613980","NCT07273643","Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality","VEEP","Inclusion Criteria:\n\n* Mother over 18 years old, able to speak and understand French\n* Newborn less than 28 weeks of gestation, born and hospitalized at Montpellier University Hospital\n* Umbilical cord venous blood collected immediately after birth (from the segment between the cord clamp and the placenta), with a volume of 10 ml (which can be reduced to 3 ml if collection is difficult) into an EDTA tube.\n* Parental non-opposition to the study obtained before sample collection\n\nExclusion Criteria:\n\n* Stillborn infant\n* Handling failure: failure to collect the sample or start the first centrifugation more than 3 hours after birth\n* General regulatory criteria: failure to obtain parental non-opposition, lack of social security coverage, individuals under legal guardianship, or participation in another ongoing research study with an active exclusion period","0 Days","3 Months",{"count":252,"type":20},30,"This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation. EVs are tiny particles released by cells that carry important information about the body's condition. In extremely premature infants, blood vessels may not function properly, leading to serious health problems such as bleeding in the brain, lung injury, or severe infections.\n\nResearchers believe that analyzing EVs in the umbilical cord blood of these infants may help predict which babies are at higher risk of developing these complications. By studying the size, number, and type of EVs, the team hopes to identify early markers that can guide doctors in providing better care.\n\nThe study will collect cord blood from 30 eligible infants born at the CHU of Montpellier. Blood samples will be processed to isolate platelet-poor plasma, which contains EVs. This plasma will be stored in a biobank, allowing future research on EVs and their role in extreme prematurity. EVs will then be analyzed in the laboratory to assess their characteristics and any links to severe health issues.\n\nThe findings from this study could improve understanding of circulatory problems in extremely premature infants, help identify early predictors of severe complications, and inform better monitoring and treatment strategies. The creation of a plasma biobank also provides a valuable resource for future research to enhance care and outcomes for this vulnerable population.",[255,256,257,258,26,259,260,261],"Intraventricular Hemorrhage","Pulmonary Hemorrhage","Death","ELGAN (22-28SA)","Shock","Extracellular Vesicles","Enterocolitis, Necrotizing",[263,264,265,266,267,268,269],"ELGAN","Extremely Low Gestational Age Newborn (ELGAN)","Extracellular vesicles","EVs","Intraventricular hemorrage","Pulmonary hemorrhage","Bronchopulmonary Dysplasia","2026-02-19",{"date":142,"type":46},{"date":273,"type":46},"2026-01-13",{"date":275,"type":20},"2027-10-13",{"name":277,"class":53},"University Hospital, Montpellier",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":124,"maxAge":21,"enrollmentInfo":285,"targetDuration":4,"studyType":66,"phases":286,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":54},"100602243","early-phase-1-metformin-for-premature-infants-with-bronchopulmonary-dysplasia-100602243","NCT07120971","Metformin for Premature Infants With Bronchopulmonary Dysplasia","A Phase 0\u002FPhase 1 Trial of Metformin for Premature Infants With Bronchopulmonary Dysplasia","Inclusion Criteria Phase 0:\n\n* Birth gestational age of \\\u003C 29 weeks AND\n* Postnatal age between 8 and 22 weeks AND\n* Diagnosed with BPD at 36 weeks postnatal age\n\nInclusion Criteria Phase 1:\n\n* Birth gestational age of \\\u003C 29 weeks, AND\n* Requiring mechanical ventilation or positive pressure support at 7 days postnatal age, AND\n* Postnatal age between 7 and 30 days\n\nExclusion Criteria:\n\n* Persistent hypoglycemia\n* Lactic acidosis\n* Feeding intolerance\n* Renal or hepatic dysfunction\n* Active infection\n* Congenital anomalies that preclude feedings\n* Infants whose parents have chosen palliative care",{"count":199,"type":20},[287],"EARLY_PHASE1","The overall objective of this study is to investigate the role of metformin in decreasing lung injury and promoting lung growth in premature infants. There are two phases to this pilot study. For Phase 0, the goal is to investigate the safety and tolerance of oral metformin in premature who have been diagnosed with bronchopulmonary dysplasia (BPD) at 36-44 weeks gestation. For Phase 1, the goal is to investigate metformin safety and tolerance in extremely premature infants who are 7-30 days old who have an increased risk of BPD. The main questions it aims to answer are:\n\n* how well do older premature infants tolerate metformin?\n* how well do younger premature infants tolerate metformin?",[26],[138,72,78,291],"metformin","2026-01-23",{"date":294,"type":46},"2026-01-26",{"date":296,"type":46},"2025-12-19",{"date":298,"type":20},"2030-09-01",{"name":300,"class":53},"Medical College of Wisconsin",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":66,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":4},"100622002","combined-oscillation-volume-guarantee-study-100622002","NCT07377955","Combined Oscillation-Volume guarantEe Study","Combined Volume Guarantee High-Frequency Oscillatory Ventilation (HFOV-VG) Versus Conventional High-Frequency Oscillatory Ventilation (HFOV) on Grade 2 to 3 Bronchopulmonary Dysplasia (BPD) or Death in Preterm Infants \u003C32 Weeks With Respiratory Distress Syndrome (RDS)","Inclusion Criteria:\n\n* Gestational age 24+0\u002F7\\\u003C 320\u002F7 weeks\n* Diagnosis of RDS within 72 hours after birth, requiring endotracheal ventilation for both elective and rescue HFOV\n\nExclusion Criteria:\n\n* Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts\n* Uncorrected shock\n* Existence of grade 3-4 IVH before ventilated\n* Other conditions deemed unsuitable for enrollment by neonatologists, including endotracheal intubation performed specifically for the purpose of the INSURE or INRECSURE technique.",{"count":309,"type":20},348,[101],"Respiratory Distress Syndrome (RDS) remains the most common respiratory complication in the early postnatal period among preterm infants born before 32 weeks' gestational age. For this population, implementing lung-protective ventilation strategies is essential to shorten the duration of intubation, reduce the incidence and severity of bronchopulmonary dysplasia (BPD), lower mortality, and improve overall outcomes.\n\nHFOV-VG was first reported in 2015 to be safely applied in neonates. The fundamental principle lies in its ability to stabilize the tidal volume of high-frequency ventilation (VThf), thereby reducing sheer stress from amplitude fluctuations, while simultaneously permitting lower VThf settings to minimize volutrauma.\n\nThis study aims to evaluate whether HFOV+VG is superior to HFOV in reducing the composite outcome of grade 2-3 BPD or death at 36 weeks' post-menstrual age (PMA).",[313,26],"Respiratory Distress Syndrome (& [Hyaline Membrane Disease])","2026-01-22",{"date":316,"type":46},"2026-01-30",{"date":318,"type":20},"2026-02-01",{"date":320,"type":20},"2028-02-01",{"name":322,"class":53},"Xingwang Zhu",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":16,"minAge":330,"maxAge":125,"enrollmentInfo":331,"targetDuration":4,"studyType":66,"phases":333,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"100596955","phase-3-dexamethasone-regimens-for-bpd-prevention-in-preterm-infants-100596955","NCT07052201","Dexamethasone Regimens for BPD Prevention in Preterm Infants","The Outcomes of Different Dexamethasone Regimens for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants: A Multicenter Randomized Controlled Trial","Inclusion Criteria (Must meet ALL of the following)\n\n1. Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone.\n2. FiO₂ \\> 40% and MAP \\> 8 cmH₂O (maintained for at least 24 hours prior to enrollment).\n3. Parent\u002FLegal guardian has provided signed informed consent.\n4. No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.\n\nExclusion Criteria (Will be excluded if they meet ANY of the following)\n\n1. Presence of ventilator-associated pneumonia at the time of enrollment.\n2. Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.\n3. Suffering from other severe life-threatening illnesses with a short-expected survival time.\n4. Parent\u002FLegal guardian refuses to participate in the study.","14 Days",{"count":332,"type":20},970,[334],"PHASE3","The goal of this clinical trial is to compare the effectiveness of two different dexamethasone treatment regimens (the DART regimen and the medium-dose tapering regimen) in reducing the incidence of Bronchopulmonary Dysplasia (BPD) or death by 36 weeks of postmenstrual age in premature infants. This study will also assess the safety of these treatments. The main questions it aims to answer are: Does the DART regimen, compared to the medium-dose tapering regimen, lower the rate of BPD or BPD-related death by 36 weeks of postmenstrual age in eligible premature infants? How do the two regimens compare in terms of short-term respiratory outcomes (like time to come off the ventilator), complications at hospital discharge, and long-term neurodevelopmental outcomes at 18-24 months of corrected age?\n\nResearchers will compare the DART regimen group (lower cumulative dose, given over 10 days) to the medium-dose tapering regimen group (higher cumulative dose, given over 7 days) to see which one is more effective and safer.\n\nParticipants will:\n\nInclusion Criteria (Must meet ALL of the following)\n\n1. Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone.\n2. FiO₂ \\> 40% and MAP \\> 8 cmH₂O (maintained for at least 24 hours prior to enrollment).\n3. Parent\u002FLegal guardian has provided signed informed consent.\n4. No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.\n\n2\\. Exclusion Criteria (Will be excluded if they meet ANY of the following)\n\n1. Presence of ventilator-associated pneumonia at the time of enrollment.\n2. Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.\n3. Suffering from other severe life-threatening illnesses with a short-expected survival time.\n4. Parent\u002FLegal guardian refuses to participate in the study.",[337,26],"Infant, Premature","2025-11-19",{"date":340,"type":46},"2025-11-24",{"date":318,"type":20},{"date":343,"type":20},"2028-05-31",{"name":345,"class":53},"The Children's Hospital of Zhejiang University School of Medicine",24,{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":355,"sex":16,"minAge":356,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":360,"conditions":361,"keywords":364,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":400,"locationsCount":54},"100603274","long-term-burden-of-bpd-and-health-related-quality-of-life-bronq-family-100603274","NCT07134387","Long-Term Burden of BPD and Health-Related Quality of Life (BronQ Family)","BronQ Family: Assessing the Long-term Impact of Bronchopulmonary Dysplasia (BPD) on Affected Families' Health-related Quality of Life","BronQ Family","Inclusion Criteria:\n\nBPD-group:\n\n* Being a parent or primary caregiver of a child until the age of 18 years (0 to under 18 years),\n\n  * who was born preterm (before 37 weeks of gestation),\n  * who has been discharged from their initial hospital stay after birth,\n  * who suffered from BPD in the newborn period and\n  * who was born or is currently living in the following countries: France, Germany, Italy, the Netherlands, Spain, the United Kingdom (including Northern Ireland) and the United States\n* providing sufficient proficiency in one of the languages of the questionnaire\n\nControl group:\n\n* Being a parent or primary caregiver of a child until the age of 18 years (0 to under 18 years),\n\n  * who was born preterm (before 37 weeks of gestation),\n  * who has been discharged from their initial hospital stay after birth,\n  * who did not suffer from BPD in the newborn period and\n  * who was born or is currently living in the following countries: France, Germany, Italy, the Netherlands, Spain, the United Kingdom (including Northern Ireland) and the United States\n* providing sufficient proficiency in one of the languages of the questionnaire\n\nExclusion Criteria:\n\nBPD-group:\n\n* Other family members than parents\u002Fprimary caregivers\n* Parents or primary caregivers\n\n  * of a child older\u002Fequal than 18 years of age\n  * of a child with BPD who has not been discharged yet\n  * of a child without a BPD in the newborn period\n  * with insufficient proficiency in one of the languages available in the questionnaire\n\nControl group:\n\n* Other family members than parents\u002Fprimary caregivers\n* Parents or primary caregivers\n\n  * of children older\u002Fequal than 18 years of age\n  * of a child born term\n  * of a child without BPD who has not been discharged yet\n  * with insufficient proficiency in one of the languages available in the questionnaire",true,"0 Years","18 Years",{"count":359,"type":20},480,"The objective of this study is to examine the long-term impact of having a child with Bronchopulmonary Dysplasia (BPD) on the parents and caregivers from the time of diagnosis through adulthood. The primary focus will be on parents and caregivers of children until the age of 18 (\\\u003C 18) years who were diagnosed with BPD as newborns. Data will be collected through an online questionnaire in France, Germany, Italy, the Netherlands, Spain, the United Kingdom (including Northern Ireland), and the United States. It will ask about inclusion and exclusion criteria, background information (caregiver, child, and family situation), the child's medical situation, parental health-related quality of life (HRQoL), health literacy, feelings, support structures, and economic burden of the family.",[26,362,363],"Chronic Lung Disease of Newborn","HRQOL (Health Related Quality Of Life)",[365,366,367,368,369,370,371,26,372,373,374,375,376,377,378,379,380,30,381,382,383,384,385,386,387,388,389,390,391,392,393],"Parental Quality of life","QoL","Health-related quality of life","HRQoL","Caregiver burden","Parental well-being","Family","Chronic Lung Disease (CLD)","Chronic Lung Diseaseof Newborn","Respiratory Morbidity","Long-term outcomes","Parents","Caregivers","Infants","Newborn","Children","Prematurity","NICU","Intensive Care","Neonatal","Survey","Questionnaire","Multinational study","retrospective data collection","participatory research","Patient-reported outcomes","PROs","Patient-reported outcome measures","PROMs","2025-11-18",{"date":396,"type":46},"2025-11-21",{"date":398,"type":46},"2025-09-16",{"date":185,"type":20},{"name":401,"class":53},"Global Foundation for the Care of Newborn Infants",{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":16,"minAge":409,"maxAge":410,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":413,"conditions":414,"keywords":416,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":54},"100602472","the-correlation-between-red-cell-transfusion-and-complications-of-prematurity-100602472","NCT07123948","The Correlation Between Red Cell Transfusion and Complications of Prematurity","The Correlation Between Packed Red Blood Cell Transfusion and Early and Late Complications of Prematurity","Inclusion Criteria:\n\n* all children born as premature infants \\\u003C32. weeks of gestation in Clinical Hospital Centre Rijeka from June 2018. to December 2021. (and who will be on September 2025. six years old)\n* signed informed consent\n\nExclusion Criteria:\n\n* genetic syndromes, severe congenital anomalies","6 Years","7 Years",{"count":412,"type":20},128,"The aim of this clinical trial is to learn if there is a correlation between the erythrocyte transfusion in the early neonatal period in premature infants and early and late complications of prematurity. The main questions it aims to answer are:\n\n* Do premature infants who receive blood transfusions within their first month of life have a higher risk of early prematurity complications, such as retinopathy of prematurity, necrotising enterocolitis, bronchopulmonary dysplasia, and intraventricular haemorrhage?\n* Do premature infants who receive blood transfusions during their first month of life have worse neurological and neurodevelopmental outcomes than those who do not? The first part of the study is retrospective, using data collected from participants' histories. The second part is prospective, evaluating neurological and neurodevelopmental outcomes at the age of six years.",[167,26,261,415],"Intraventricular Hemorrhage Neonatal",[417,418,419],"Infant, Premature;","Erythrocyte Transfusion","Neurodevelopmental Disorder","2025-08-12",{"date":422,"type":46},"2025-08-14",{"date":424,"type":20},"2025-09-01",{"date":426,"type":20},"2029-03-01",{"name":428,"class":53},"Clinical Hospital Center Rijeka",{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":16,"minAge":437,"maxAge":330,"enrollmentInfo":438,"targetDuration":4,"studyType":66,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":458},"100597402","phase-2-mesenchymal-stromal-cell-therapy-to-prevent-bronchopulmonary-dysplasia-in-extreme-preterm-infants-100597402","NCT07058025","Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants","Mesenchymal Stromal Cells in Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia - A Phase 2 Multi-Centre Double Blind Randomized Controlled Trial","HULC-2","Inclusion Criteria:\n\n* Gestational age (GA) less than 28+0 weeks\n* Post-natal age between 4 and 14 days of life\n* Invasive ventilation with oxygen requirement:\n\n  * On mechanical ventilation: intubated patient with any of the following ventilation modes: conventional, HFO or Jet ventilation:\n  * With requirement of FiO2: FiO2 \\>= 30% and for at least 12 hours over 24 hours (i.e. flowsheets, FiO2 histogram)\n\nExclusion Criteria:\n\n1. Congenital anomaly:\n\n   * Genetic and chromosomal syndromes (e.g., Trisomy 13, Trisomy 18, Trisomy 21): either patient with high suspicion (antenatal findings, clinical features) or documented syndrome by genetic testing.\n   * Major congenital anomalies including cardiac (i.e., congenital heart defects, NB. PDA is not considered an exclusion criterion), neurological (e.g., holoprosencephaly, anencephaly), gastrointestinal (e.g., gastroschisis, omphalocele), pulmonary (e.g., congenital diaphragmatic hernia) anomalies.\n   * Inborn errors of metabolism.\n2. Hemodynamic instability (shock):\n\n   * Hemodynamic instability with impaired end-organ perfusion (metabolic acidosis with increased lactate and\u002For decreased urine output).\n   * Requirements for fluid bolus, inotrope or vasopressor medication\n3. Severe sepsis:\n\n   * Signs of hemodynamic instability and requiring at least one fluid bolus.\n   * And a positive blood or cerebrospinal fluid culture.\n4. Pneumothorax: Pneumothorax with a chest tube in place\n5. Severe pulmonary hemorrhage:\n\n   * Active pulmonary hemorrhage (i.e., frank blood coming from the endotracheal tube.\n   * And at least one of the following criteria: a)hemodynamic instability. b) blood product transfusion (packed red blood cells, platelets, fresh frozen plasma)\n6. Extubation: If Extubation planned within the next 24 hours (post first uc-MSC administration\u002Fsham procedure).\n7. Patient is not expected to survive:\n\n   * Redirection of care.\n   * Patient is moribund","4 Days",{"count":439,"type":20},168,[130],"This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth.\n\nStudy participants will receive either multiple intravenous doses (total of 3 doses) of MSC derived from human donor umbilical cord tissue (intervention group) or no uc-MSC injection (control group) to confirm the safety of IV MSC in extreme preterm infants and evaluate the potential benefit of MSC therapy on their respiratory health as well as on other complications related to preterm birth.",[26,258],[444,445,446,447,269,448],"Phase II clinical trial","Mesenchymal stromal cell","Cell therapy","Preterm infant","Extremely low gestational age neonates","2025-07-08",{"date":451,"type":46},"2025-07-10",{"date":453,"type":20},"2025-10-01",{"date":455,"type":20},"2038-09-30",{"name":457,"class":53},"Ottawa Hospital Research Institute",8,{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":16,"minAge":466,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":481,"leadSponsor":483,"locationsCount":54},"100588396","chloride-imbalance-in-preterm-infants-100588396","NCT06940856","Chloride Imbalance in Preterm Infants","The Impact of Chloride Imbalance on BPD Development and Mortality in Preterm Infants","Inclusion Criteria:\n\n* Infants born \\\u003C32 weeks PMA or \\\u003C1500 grams\n* Infants admitted to NICU within the first 24 hours\n\nExclusion Criteria:\n\n* Infants with major congenital anomalies\n* Infants with chromosomal anomalies\n* Infants who have undergone enterostomy operation\n* Infants admitted to NICU after the first 24 hours","1 Hour","6 Weeks",{"count":469,"type":20},500,"In adults and children low or high blood chloride levels are linked to the risk of death. The aim of this observational study is to determine whether there is a relationship between low or high blood chloride levels and the risk of death or long-term lung problems. We will also learn the risk factors and associated conditions of high or low blood chloride levels. We will include infants born before 32 weeks of pregnancy or have a birth weight of less than 1500 grams in the study. The main question it aims to answer is:\n\nIs there a relationship between low or high blood chloride levels in the first 4-6 weeks of life and risk of death or long-term lung problems in premature babies? We will examine the medical reports of babies who were followed up in neonatal intensive care unit over the past 5 years.",[26,472,473],"Mortality Prediction","Chloride Disorder",[177,447,475,476],"Mortality","Chloride imbalance","2025-04-15",{"date":479,"type":46},"2025-04-23",{"date":477,"type":20},{"date":482,"type":20},"2026-10-15",{"name":484,"class":53},"Kanuni Sultan Suleyman Training and Research Hospital",{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":16,"minAge":356,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":495,"conditions":496,"keywords":503,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":519},"100569316","overview-use-of-respiratory-support-at-home-in-children-100569316","NCT06692660","Overview: Use of Respiratory Support At Home in Children","An Overview of the Use of Respiratory Support At Home in Children - Patients and Families Point of View","ELIPSE","Inclusion Criteria:\n\n* Children with respiratory support at home\n* Age 0 to 18 (not yet passed) years old\n\nExclusion Criteria:\n\n* Palliative care\n* Invasive ventilation\n* High flow oxygen therapy","17 Years",{"count":252,"type":20},"the primary outcome is to describe the perceived success of the use of the respiratory support from the parent's point of view",[497,498,26,499,500,501,502],"Sleep Apnea Syndromes in Children","Obesity in Children","Neuromuscular Disease","Storage Disease","Malformation","Alveolar Hypoventilation",[504,505,95,506,507,508,509],"respiratory suport","sleep apnea syndrome","BiPAP","ventilation","alveolar hypoventilation","non invasive ventilation","2024-11-14",{"date":512,"type":46},"2024-11-18",{"date":514,"type":20},"2024-11",{"date":516,"type":20},"2025-08",{"name":518,"class":53},"University Hospital, Grenoble",2,{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":11,"sex":16,"minAge":528,"maxAge":529,"enrollmentInfo":530,"targetDuration":4,"studyType":66,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":4},"100547540","phase-3-enhancing-lung-health-in-kids-with-structural-lung-damage-and-malformations-azithromycin-azi-for-airway-infection-prevention-100547540","NCT06409299","Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: Azithromycin (AZI) for Airway Infection Prevention","Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: a Randomized Controlled Trial on Azithromycin (AZI) for Airway Infection Prevention","TRALULALA-AZI","Inclusion Criteria:\n\n1. CT and bronchoscopy verified and structural lung damage or congenital lung and airway malformations\n2. Outpatient affiliation with one of the three highly specialized pediatric pulmonology centers.\n3. At risk of or already documented respiratory infections requiring antibiotics.\n4. Age between 0-72 months at inclusion.\n\nExclusion Criteria:\n\n1. Asthmatic challenges: Patients without any of the conditions mentioned in table 1 repeatedly experiencing asthmatic problems are not eligible for this study.\n2. Cystic fibrosis (CF) or primary ciliary dyskinesia (PCD): Patients with a CF or PCD diagnosis will be excluded.\n3. Impaired liver function: Children with an alanine transaminase (ALAT) twice or more the upper limits of normal will be excluded.\n4. Impaired kidney function: Children with a serum creatinine higher than the upper limit of normal for age will be excluded.\n5. Neurological or psychiatric disorders\n6. Prolonged QT interval: Patients with either congenital or acquired prolonged QT interval will be excluded.\n7. Heart disease: Patients with clinically relevant bradycardia, cardiac arrhythmia or severe heart failure are not eligible for this study.\n8. Allergy to macrolide antibiotics: documented allergy to macrolide antibiotics (extremely rare) will result in exclusion from the study.","0 Months","72 Months",{"count":531,"type":20},150,[334],"Children with lung and airway malformations or early structural lung damage face significant challenges, often leading to recurrent respiratory infections, hospitalizations, and decreased quality of life. Despite various interventions, effective strategies are urgently needed.\n\nThe link between these conditions and persistent bacterial bronchitis remains unclear, possibly due to compromised airways and reduced mucociliary clearance. Although antibiotics can alleviate symptoms, relapse is common.\n\nExperts often prescribe prophylactic azithromycin, despite limited evidence of its benefits. Azithromycin shows promise due to its anti-inflammatory and immunomodulatory effects but lacks thorough evaluation in this population.\n\nTo address this gap, we propose a double-blind, randomized controlled trial to assess azithromycin's effectiveness and safety in preventing respiratory infections in children with these conditions. This research aims to inform clinical practice and improve the health of affected children and their families.",[535,26,536,537,538,539],"Tracheomalacia","Vascular Ring","Cystic Lung Disease","Bronchiectasis","Chronic Atelectasis","2024-05-10",{"date":542,"type":46},"2024-05-14",{"date":544,"type":20},"2024-09-01",{"date":546,"type":20},"2027-08-31",{"name":548,"class":53},"Rigshospitalet, Denmark"]