[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"apnea-of-prematurity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:apnea-of-prematurity":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,54,80,116,150,172,204,230,254,281,308,331,356],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100642471","phase-4-fentanyl-and-rocuronium-for-tracheal-intubation-in-newborns-100642471",false,"NCT07650552","Fentanyl and Rocuronium for Tracheal Intubation in Newborns","Effect of the Association of Fentanyl and Rocuronium on First-Attempt Success Rate of Tracheal Intubation in Newborns: A Randomized Clinical Trial","NEORIN","Inclusion Criteria:\n\n* Newborns admitted to the NICU, ≤28 postnatal days OR corrected gestational age \\\u003C44 weeks\n* Indication for non-emergent orotracheal intubation (≥5 minutes between decision to intubate and start of laryngoscopy)\n* Informed consent signed by legal guardians\n\nExclusion Criteria:\n\n* Upper airway malformations\n* Use of neuromuscular blocking agent in the 24 hours prior to enrollment\n* Known hypersensitivity to fentanyl or rocuronium\n* Severe hemodynamic instability (ongoing shock)\n* Anticipated difficult airway (micrognathia, cleft palate, or similar)\n* Cyanotic congenital heart disease with critical instability\n* Neonatal abstinence syndrome\n* Concurrent enrollment in another interventional clinical trial","ALL","1 Minute","28 Days",{"count":21,"type":22},102,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Tracheal intubation is a common and critical procedure in neonatal intensive care units (NICU). Despite its clinical importance, first-attempt success rates remain low (approximately 50%), and adverse events - including oxygen desaturation, bradycardia, and airway trauma - are frequent. Premedication with neuromuscular blocking agents has been associated with improved intubation conditions and fewer adverse events in neonates.\n\nThis randomized, double-blind, parallel-group clinical trial (NEORIN) aims to evaluate whether the addition of rocuronium (0,6 mg\u002Fkg IV) to standard fentanyl premedication (1 mcg\u002Fkg IV) improves first-attempt success rates of tracheal intubation in newborns admitted to the NICU of Maternidade Ana Braga, Manaus, Brazil. The control group will receive fentanyl plus saline placebo. Sugammadex (16 mg\u002Fkg IV) is available as a reversal agent in case of prolonged neuromuscular blockade.\n\nA secondary aim is to assess neonatologists' and residents' knowledge of and barriers to the use of neuromuscular blocking agents in neonatal intubation.",[28,29,30,31],"Infant, Premature","Intubation, Intratracheal","Respiratory Distress Syndrome, Newborn","Apnea of Prematurity",[33,34,35,36,37,38,39,40],"neonatal intubation","rocuronium","premedication","neuromuscular blocking agent","sugammadex","first-attempt success","NICU","newborn","NOT_YET_RECRUITING","2026-06-29",{"date":44,"type":45},"2026-07-01","ACTUAL",{"date":47,"type":22},"2026-09",{"date":49,"type":22},"2029-02",{"name":51,"class":52},"UEA - Universidade Do Estado Do Amazonas","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":53},"100555939","phase-4-caffeine-citrate-in-preterm-infants-at-risk-of-apnea-in-zambia-100555939","NCT06518603","Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia","Randomized Controlled Trial of Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia","Inclusion Criteria:\n\nNewborns:\n\n1. 29 0\u002F7 to 33 6\u002F7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU,\n2. On methylxanthines with plans to discontinue on methylxanthine,\n3. Off oxygen therapy for \\>48 hours at the time of evaluation for eligibility,\n4. Receiving full daily feeds,\n5. Deemed stable and ready to go off caffeine as recommended by the Neonatologist\n6. 18+ years of age (parent)\n\nExclusion Criteria:\n\n1. Newborns with neuromuscular conditions affecting respiration,\n2. Major congenital malformations and genetic disorders,\n3. Unable to obtain parental or guardian consent","0 Days","12 Months",{"count":64,"type":22},340,[25],"The goal of this clinical trial is to learn if caffeine citrate prevents apneic events that result in sick visits in moderately preterm infants after discharge from the hospital. It will also learn if the use of caffeine leads to better developmental outcomes at 12 months of age.\n\nOur research questions are:\n\n1. Does continued treatment of moderately preterm newborns with caffeine citrate after hospital discharge prevent or decrease apneic events that result in sick visits?\n2. Will the continued use of caffeine citrate lead to improved developmental outcomes among infants at 12 months of age?\n\nResearchers will compare caffeine citrate to a placebo (a look-alike substance that contains no drug) to see if caffeine citrate prevents apneic spells which result in healthcare visits.\n\nParents of participants will:\n\n1. Administer caffeine citrate 20mg\u002Fkg\u002Fday or a placebo (equivalent volume of sterile water) orally every day for up to 28 days after hospital discharge\n2. Keep a diary of symptoms and any apneic events\n3. Check in with researchers via telephone call once a week\n4. Return to clinic for infant physical examination at 28 days\n5. Return to the clinic for infant physical examination at 2 months\n\n5\\. Return to clinic for infant neurodevelopmental examination with Ages and Stages Questionnaire at 12 months of age",[68,31,69],"Premature Infant Disease","Development, Infant","RECRUITING","2026-06-18",{"date":73,"type":45},"2026-06-23",{"date":75,"type":45},"2026-06-17",{"date":77,"type":22},"2027-06-30",{"name":79,"class":52},"University of Alabama at Birmingham",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":88,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":53},"100636779","phase-1-pharmacokinetics-and-placental-transfer-of-caffeine-100636779","NCT07570121","Pharmacokinetics and Placental Transfer of Caffeine","Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy","AnteCaff","Inclusion Criteria:\n\n1. Pregnant women with risk of preterm delivery at 23 - 31+6 weeks with singleton gestation who are inpatient without a plan for discharge before delivery.\n2. Informed consent provided for participation.\n3. Cesarean delivery.\n\nExclusion Criteria:\n\n1. Known major fetal congenital anomalies or genetic disorders.\n2. Plan in place for limited neonatal resuscitation or comfort care only.\n3. Preterm, premature rupture of membranes prior to 22 weeks gestation with concern for pulmonary hypoplasia.\n4. Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorder.\n5. Fetal arrhythmia.\n6. Seizure disorder.\n7. Oligohydramnios due to renal anomalies or renal impairment.\n8. Current or anticipated use of products that include sodium benzoate.\n9. Maternal age \\\u003C18 years.\n10. Maternal medical conditions in which caffeine or other stimulants would be contraindicated.\n11. High likelihood of receiving terbutaline.\n12. Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide.\n13. Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and\u002For compromise the objectives of the study.","FEMALE","18 Years",{"count":91,"type":22},30,[93],"PHASE1","The goal of this study is to learn how a pregnant person's body processes caffeine and how much caffeine crosses the placenta to the baby. A small dose of caffeine will be given to each pregnant participant before delivery. Blood will be drawn to measure caffeine levels in the pregnant mother. Blood will also be taken from the placenta and from the newborn to measure caffeine levels. This data will be used to form a computer model of the metabolism of caffeine during pregnancy.",[96,97,31,98,99],"Preterm Labor With Preterm Delivery","Premature Birth","Respiratory Distress Syndrome","Bronchopulmonary Dysplasia",[101,102,103,104,105,106],"caffeine","preterm labor","prematurity","pharmacokinetics","bronchopulmonary dysplasia","apnea of prematurity","2026-06-03",{"date":109,"type":45},"2026-06-04",{"date":111,"type":45},"2026-06-01",{"date":113,"type":22},"2027-06",{"name":115,"class":52},"Indiana University",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":124,"enrollmentInfo":125,"targetDuration":127,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":53},"100635387","detection-of-respiratory-events-using-acoustic-monitoring-in-extremely-preterm-infants-100635387","NCT07552025","Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants","Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants (DREAM 2)","DREAM 2","Inclusion Criteria:\n\n* Infants with gestational age \\\u003C 29+0 weeks.\n* Off respiratory support at the time of study recording.\n\nExclusion Criteria:\n\n* Infants with known major congenital anomalies.\n* Infants deemed clinically unstable for the study by the attending physician.","29 Weeks",{"count":126,"type":22},50,"9 Weeks","OBSERVATIONAL","Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems. These respiratory events include pauses in breathing, shallows breaths, and irregular breathing patterns. These problems are most common right after birth but can continue for weeks, leading to extended hospital stays, higher medical costs, and potential long-term health concerns affecting the eyes, lungs, and brain.\n\nCurrently, neonatal intensive care units (NICUs) use methods like measuring oxygen levels, heart rate, and electrical resistance in the chest to monitor for respiratory events. However, these methods have limitations. For instance, they cannot accurately measure airflow and do not distinguish between different types of respiratory events. As a results, some breathing problems might go unnoticed or be managed improperly.\n\nTo address this, the investigators have developed a wireless acoustic sensor that uses advanced microphones and motion sensors to record airflow and chest movements. In initial tests with healthy preterm infants, this sensor proved reliable in detecting breathing patterns and airway obstruction, suggesting it could offer a more precise and non-invasive monitoring method.\n\nThis study aims to assess how well this new sensor performs compared to existing methods in detecting and distinguishing different types of respiratory events in a high-risk group of extremely preterm infants. The investigators will track respiratory patterns in preterm infants at various stages between 32 and 44 weeks of age. By comparing the new sensor's performance with currents standards and gold-standard methods, the investigators hope to improve the management of these respiratory events and reduce the related health risks.",[31,131,132,133],"Preterm Infant","Periodic Breathing","Hypopnea",[135,136,137,138,139,140],"Apnea of prematurity","Preterm infants","Diagnostic accuracy study","Respiratory acoustics","Respiratory events","Neonatal Intensive Unit Care","2026-05-07",{"date":143,"type":45},"2026-05-12",{"date":145,"type":22},"2026-05",{"date":147,"type":22},"2028-09",{"name":149,"class":52},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":157,"enrollmentInfo":158,"targetDuration":157,"studyType":128,"phases":4,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":53},"100617924","the-role-of-electroencephalography-in-caffeine-discontinuation-timing-in-premature-infants-100617924","NCT07324941","The Role of Electroencephalography in Caffeine Discontinuation Timing in Premature Infants","The Role of Electroencephalography Evaluation in Caffeine Discontinuation Timing in Premature Infants","Inclusion Criteria:\n\n1. Infants born before 28 weeks of gestation with a birth weight of 1250 grams or less, who received prophylactic caffeine therapy.\n2. Infants with a birth weight greater than 1250 grams and a gestational age below 32 weeks, who required invasive mechanical ventilation and were started on prophylactic caffeine therapy.\n3. Infants born at less than 37 weeks of gestation, admitted to the neonatal intensive care unit, and treated with caffeine for apnea of prematurity.\n4. Infants whose parents or legal guardians provided informed consent.\n\nExclusion Criteria:\n\n1. Infants who did not receive caffeine therapy,\n2. Infants for whom an EEG could not be performed,\n3. Infants with major congenital malformations such as neuromuscular disorders, central nervous system developmental abnormalities, thoracic malformations, or major cardiac anomalies,\n4. Infants who were transferred to another facility within one week before or after discontinuation of caffeine therapy.","1 Month",{"count":159,"type":22},100,"The aim of this observational study is to investigate whether functional maturation assessment by electroencephalography in preterm infants can provide reliable data for the safe discontinuation of caffeine therapy without recurrence of apnea.\n\nIn preterm infants receiving caffeine therapy, an assessment of maturation will be performed by EEG at the time when discontinuation of caffeine treatment is planned.",[162,31],"Apnea Neonatal","2026-04-27",{"date":165,"type":45},"2026-05-01",{"date":167,"type":45},"2026-01-02",{"date":169,"type":22},"2027-01-02",{"name":171,"class":52},"Uludag University",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":182,"studyType":128,"phases":4,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100538550","the-pars-study-paediatric-advanced-respiratory-service-study---an-observational-diagnostic-feasibility-study-100538550","NCT06292299","The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study","PARS","Inclusion Criteria:\n\nGroup 1 - CR-poly group\n\n* Patient undergoing overnight CR-poly\n* Age birth to \\>=16 years\n* Are willing and able to give informed assent\u002Fconsent or have available next of Kin to provide informed consent on the participant\\'s behalf\n* Able (in the Investigators opinion) to comply with all study requirements\n* Can speak and read English\n\nGroup 2 - Apnoea group\n\n* Inpatient in neonatal unit\n* Age birth (from 30 weeks gestational age) to term corrected\n* Parents willing and able to give informed consent\n* Able (in the Investigators opinion) to comply with all study requirements\n* Can speak and read English\n\nGroup 3- VT Group attending epilepsy monitoirng unit\n\n* Inpatient receiving video-telemetry epilepsy monitoring unit\n* Age birth to \\\u003C16 years\n* Parents willing and able to give informed consent\n* Able (in the Investigators opinion) and willing to comply with all study requirements\n* Can speak and read English\n\nExclusion Criteria:\n\nGroup 1 - CR-poly group\n\n* Unable to provide consent and no next of kin to provide consent on participants behalf\n* Treating clinician deems patient inappropriate to be included in study\n\nGroup 2 - Apnoea group\n\n* No next of kin to provide consent on participants behalf\n* Treating clinician deems patient inappropriate to be included in study\n\nGroup 3- VT Group attending epilepsy monitoirng unit\n\n* Unable to provide consent and no next of kin to provide consent on participants behalf\n* Treating clinician deems patient inappropriate to be included in study","16 Years",{"count":181,"type":22},225,"7 Days","Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with \"gold standard equipment\". Children with sensory\u002Fbehavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomes\n\nInfants in the neonatal period can have immature breathing control which manifests as excessive central breathing pauses, apnoea's, whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected neonatal collapse, even in \"low risk\" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard monitoring equipment. Effective monitoring and appropriate treatment of apnoea's has been shown to improve prognosis in terms of 5-year mortality and neurodevelopmental outcomes.\n\nChildren with epilepsy are at risk of epileptic apnoea during a seizure (ictal) or post-ictal apnoea following an epileptic seizure. Epileptic and post-ictal apnoea have been implicated as causes of sudden unexpected death in epilepsy (SUDEP). Epilepsy affects approx. 50 million people worldwide. The risk of SUDEP varies in different underlying causes of epilepsy but is estimated to be the cause of 1.2 deaths for every 1,000 children with epilepsy each year.\n\nThis observational study is part of a phased clinical program of research that aims to validate a small wearable biosensor developed by PneumoWave Ltd in a paediatric clinical setting with the overall primary endpoints of monitoring and assessing respiratory pattern as an aid to sleep diagnostics, and as a device to monitor apnoea in neonatal patients and children with epilepsy at risk of SUDEP.",[185,31,186,187],"Sleep Disordered Breathing","Respiratory Rate","Sudden Unexpected Death in Epilepsy",[185,189,190,191,186,192,193],"Neonatal Apnoea","Sleep Diagnostics","Wearable Device","Respiratory Pattern","Epilepsy","2026-04-13",{"date":196,"type":45},"2026-04-14",{"date":198,"type":45},"2024-03-01",{"date":200,"type":22},"2027-12",{"name":202,"class":52},"NHS Greater Clyde and Glasgow",2,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":211,"sex":17,"minAge":4,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":203},"100623397","efficacy-of-pimun-by-reducing-intermittent-hypoxia-events-100623397","NCT07396103","Efficacy of PIMUN by Reducing Intermittent Hypoxia Events","Clinical Study of Intermittent Hypoxia Reduction Using PIMUN: Efficacy Proof-of-Concept","Inclusion Criteria:\n\n* Preterm infants with a gestational age at birth \\\u003C34 weeks\n* Age \\\u003C30 days at the time of enrollment\n* Documented diagnosis of apnea of prematurity (AOP)\n\nExclusion Criteria:\n\n* Currently receiving mechanical ventilation (MV)\n* Presence of major congenital malformations\n* Clinically unstable or critically ill at the time of screening\n* Active sepsis or undergoing treatment for sepsis\n* Intraventricular hemorrhage (IVH) Grade \\> II\n* Receiving sedatives or anticonvulsant medications",true,"30 Days",{"count":214,"type":22},20,[216],"NA","The goal of this clinical trial is to learn if the use of PIMUN(medical device) works to reduce the intermittent hypoxemia of 24-34 weeks of birth gestational age babies. . It will also learn about the safety of the use of PIMUN. The main questions it aims to answer are:\n\nDoes PIMUN lower the time of oxygen saturation under 90%? What medical problems do participants have using PIMUN? Researchers will compare the use of PIMUN during 48 hours to 48 hours of usual treatments (not using PIMUN).\n\nParticipants will:\n\nUse\u002F or not use of PIMUN for a 48 hours period- randomly assigned. Regional brain oxygenation by near infrared spectroscopy (NIRS) monitoring at the first day of each 48 hours period. 4-6 hours of polysomnography at the second day of each intervention. Plasma and urine stress oxygen metabolites at the end of each 48-hours intervention.",[219,31,220],"Preterm","Hypoxemia","2026-02-03",{"date":223,"type":45},"2026-02-09",{"date":225,"type":45},"2024-09-01",{"date":227,"type":22},"2026-05-31",{"name":229,"class":52},"Pontificia Universidad Catolica de Chile",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":4},"100614082","the-effect-of-caffeine-therapy-in-cardiovascular-stability-in-preterm-neonates-at-assiut-university-children-hospital-nicu-100614082","NCT07274969","The Effect of Caffeine Therapy in Cardiovascular Stability in Preterm Neonates at Assiut University Children Hospital NICU","The Effect of Caffeine Therapy in Cardiovascular Stability in Preterm Neonates: a Prospective Study at the Neonatal Intensive Care Unit of Assiut University Children Hospital","Inclusion Criteria:\n\n* Preterm neonates with gestational age \\\u003C37 weeks\n* Receiving caffeine therapy for apnea of prematurity\n* Hemodynamically stable before caffeine initiation\n\nExclusion Criteria:\n\n* Presence of major congenital anomalies\n* Use of vasopressors at baseline\n* Severe intraventricular hemorrhage (Grade III-IV)","37 Weeks",{"count":239,"type":22},40,"Preterm neonates younger than 37 weeks gestational age receiving caffeine therapy for apnea of prematurity in a NICU setting.",[242,31],"Preterm Neonates",[244,106],"Preterm neonates","2025-12-09",{"date":247,"type":45},"2025-12-10",{"date":249,"type":22},"2026-06-30",{"date":251,"type":22},"2027-12-30",{"name":253,"class":52},"Assiut University",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":261,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":53},"100462214","the-effect-of-womb-recordings-on-maturation-of-respiratory-control-in-preterm-infants-100462214","NCT05298748","The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants","Womb Recordings and Respiratory Control Maturation in Neonates","Inclusion Criteria:\n\n* preterm infants 29-33 weeks gestational age at birth\n* 34 weeks corrected age\n* off respiratory support \\>1.5 lpm\n\nExclusion Criteria:\n\n* on respiratory support \\>1.5 lpm\n* congenital anomalies","1 Week","5 Weeks",{"count":264,"type":22},34,[216],"The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.",[31,268,269],"Intermittent Hypoxemia","Bradycardia",[271],"apnea, intermittent hypoxemia, bradycardia, audio recording","2025-12-04",{"date":274,"type":45},"2025-12-05",{"date":276,"type":45},"2022-09-16",{"date":278,"type":22},"2026-11",{"name":280,"class":52},"Case Western Reserve University",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":4},"100590855","caffeine-citrate-to-improve-neonatal-outcomes-100590855","NCT06972849","Caffeine Citrate to Improve Neonatal Outcomes.","BabyCCINO: Caffeine Citrate to Improve Neonatal Outcomes. A Neonatal Domain Within PLATIPUS.","BabyCCINO","PLATFORM ELIGIBILITY\n\nParticipants must meet all core PLATIPUS platform inclusion criteria:\n\n* Born before 37 weeks gestation\n* Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and\n* Meet eligibility criteria for one or more platform domains.\n\nParticipants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:\n\n* (Parent) Inability to consent for their infant, unless a domain-level waiver of consent is deemed appropriate.\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening), including if neonatal intensive care is not being provided to the infant.\n\nInfants who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for BabyCCINO-specific eligibility.\n\nBabyCCINO-SPECIFIC ELIGIBILITY\n\nPlatform-eligible participants must meet all BabyCCINO-specific inclusion criteria:\n\n1. Very preterm infants born \\\u003C32 weeks' gestation\n2. \\\u003C72 hours old\n3. Very preterm infants born at \\\u003C32 weeks' gestation, \\\u003C72 hours of age, with any clinical indication for commencing caffeine, as determined by the treating clinician, including:\n\n   * Prevention or treatment of apnoea\n   * Facilitating extubation from mechanical ventilation\n   * Prevention of BPD\n   * For longer-term benefit.\n\nParticipants will be excluded from participation if they meet any BabyCCINO-specific exclusion criteria:\n\n1. Prior treatment with caffeine, other methylxanthines, or doxapram\n2. Major congenital anomalies: major congenital cardiac disease (not including patent ductus arteriosus or isolated atrial\u002Fventricular septal defects), major gastrointestinal malformations, congenital diaphragmatic hernia, known genetic syndromes, known brain malformations\n3. Death considered to be imminent in the next 24 hours, or intensive care not going to be offered or continued\n4. Pre-existing tachyarrhythmia (e.g., antenatal or postnatal supraventricular tachycardia)\n5. Pre-existing seizures\n6. No parental\u002Fcaregiver consent or not satisfying the principles and criteria for waiver with consent to continue, as approved in the relevant jurisdiction\n\nPlatform-eligible participants who meet all BabyCCINO-specific inclusion criteria and none of the BabyCCINO-specific exclusion criteria will be eligible to participate in BabyCCINO.","32 Weeks",{"count":291,"type":22},3900,[216],"The goal of this clinical trial to learn what dose\u002Fs of caffeine citrate works to treat preterm born babies who have episodes where they stop breathing. It will also learn about the safety of different doses of caffeine citrate for the variety of preterm-born babies that are prescribed this.\n\nThe main question it aims to answer is: Which dose is the optimal dose of caffeine citrate for very preterm babies to prevent short-term death and disease?\n\nResearchers will compare three different doses of caffeine citrate, which are already used in clinical practice to treat breathing stoppages in preterm babies, to see which dose works best. No placebo will be used.\n\nParticipants will be given a 'loading' dose of caffeine citrate \\\u003C72 hours of life, and a smaller 'maintenance' dose once a day, for as long as the baby needs this.\n\nThis trial will be undertaken as part of the PLATIPUS trial (NCT06461429).",[31],[296,31,297,298],"Preterm infant","Apnoea of Prematurity","Caffeine citrate","2025-05-06",{"date":301,"type":45},"2025-05-15",{"date":303,"type":22},"2025-10",{"date":305,"type":22},"2050-12",{"name":307,"class":52},"University of Melbourne",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":203},"100544842","prapela-svs-incubator-pad-for-apnea-of-prematurity-100544842","NCT06374147","\"Prapela® SVS Incubator Pad for Apnea of Prematurity","\"Prapela® SVS Incubator Pad: a Cost-effective Stochastic Vibrotactile Device to Improve the Clinical Course of Infants with Apnea of Prematurity.\"","Prapela AOP","Inclusion Criteria:\n\n* 22 week 0 days-32 weeks 6 days gestational age (preterm)\n* Either sex\n* Single birth\n* At least 4 clinically documented apnea events in the previous 24 hours\n* Caffeine citrate at least 5 mg\u002Fkg\u002Fday dosing, with or without respiratory support oxygen, nasal cannula, or CPAP without and added rate or pressure support, if considered necessary by the clinical team)\n\nExclusion Criteria:\n\n* Intubation and mechanical ventilation, or non-invasive positive pressure ventilation (NIPPV) if not intubated, or pressure support breaths while on CPAP.\n* Refusal or withdrawal of consent\n* Major congenital malformations (not including patent ductus arteriosus, small hernia)\n* Known disorder of breathing other than apnea of prematurity (e.g., congenital central hypoventilation syndrome, laryngotracheomalacia)\n* Caffeine citrate dosing exceeding FDA recommended dosing in the first 24 hours, if deemed necessary by the clinical team","3 Months",{"count":318,"type":22},140,[216],"The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk\u002Fbenefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay.",[31],"2025-03-04",{"date":324,"type":45},"2025-03-07",{"date":326,"type":45},"2025-02-06",{"date":328,"type":22},"2026-12-31",{"name":330,"class":52},"Tufts Medical Center",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":203},"100546908","phase-4-the-effect-of-an-additional-pre-extubational-loading-dose-of-caffeine-citrate-100546908","NCT06401083","The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate","NEOKOFF22","Inclusion Criteria:\n\n* Premature infant born before 32nd week of gestation is completed;\n* Had been mechanically ventilated for at least 48 hours;\n* Before the first planned extubation.\n\nExclusion Criteria:\n\n* Lack of informed consent, refusal to participate in the study;\n* Major congenital anomaly;\n* Had not received surfactant treatment;\n* Hydrops foetalis;\n* Persistent tachycardia before extubation, fetal\u002Fneonatal arrhythmia;\n* Asphyxia.",{"count":339,"type":22},226,[25],"The goal of this clinical trial is to answer whether the use of a single loading dose (20 mg\u002Fkg) of caffeine citrate one hour before extubation has an impact on the success rate of extubation among preterm neonates. In addition, the investigators would like to assess the frequency of apneas and side effects of the intervention, as well as the development of NEC, BPD, IVH, PVL, and long-term neurodevelopmental outcomes in the investigated populations.\n\nAccording to institutional protocol, preterm infants born before the 32nd week of gestation receive a standard dose of caffeine citrate therapy. This covers a maintenance dose of 5-10 mg\u002Fkg of caffeine citrate administered intravenously once or twice daily after a loading dose of 20 mg\u002Fkg on the first day of life. In this trial, preterm infants born before the 32nd gestational week and who had been mechanically ventilated for at least 48 hours before planned extubation are planned to be randomly allocated into intervention and control groups. The intervention group will receive an additional loading dose of caffeine citrate 60 minutes before extubation. The control group will receive standard dosing regimens.",[31,97,343],"Respiratory Failure",[103,101,345,106,346],"methylxanthine","extubation failure","2024-05-01",{"date":349,"type":45},"2024-05-06",{"date":351,"type":45},"2023-12-21",{"date":353,"type":22},"2028-12",{"name":355,"class":52},"Semmelweis University",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":17,"minAge":363,"maxAge":124,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":383},"100395568","phase-3-doxapram-therapy-in-preterm-infants-doxa-trial-100395568","NCT04430790","Doxapram Therapy in Preterm Infants (DOXA Trial)","Doxapram Versus Placebo in Preterm Newborns: An International Double Blinded Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Admitted to the neonatal intensvie care unit (NICU) of one of the participating centres\n* Written informed consent of both parents or legal representatives\n* Gestational age at birth \\\u003C 29 weeks\n* Caffeine therapy, adequately dosed (see also under co-medication)\n* Optimal Non-invasively supported with nasal Continuous Positive Airway Pressure (CPAP) or ventilation ((S)NIPPV, NIV-NAVA, BIPAP\u002FDuopap, SIPAP)\n* Apnea that require a medical intervention as judged by the attending physician\n\nExclusion Criteria:\n\n* Previous use of open label doxapram\n* Use of theophylline (to replace doxapram)\n* Chromosomal defects (e.g. trisomy 13, 18, or 21)\n* Major congenital malformations that: compromise lung function (e.g. surfactant protein deficiencies, congenital diaphragmatic hernia); result in chronic ventilation (e.g. Pierre Robin sequence); increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations, chromosomal abnormalities);\n* Palliative care or treatment limitations because of high risk of impaired outcome.","23 Weeks",{"count":365,"type":22},396,[367],"PHASE3","Preterm infants often suffer from apnea of prematurity (AOP; a cessation of breathing) due to immaturity of the respiratory system. AOP can lead to oxygen shortage and a low heart rate which might harm the development of the newborn, especially the central nervous system. In order to prevent oxygen shortage, infants are treated with non-invasive respiratory support and caffeine. Despite these treatments, many preterm newborns still suffer from AOP and need invasive mechanical ventilation. Although this will result in complete resolution of AOP, invasive mechanical ventilation has the disadvantage of being a major risk of chronic lung disease and impaired neurodevelopmental outcome. Restrictive invasive ventilation is therefore advocated nowadays in preterm infants. Doxapram is a respiratory stimulant that has been administered off-label to treat AOP. Doxapram, as add-on treatment, seems to be effective in treating AOP and to prevent invasive mechanical ventilation. It is unclear if a preterm infant benefit from doxapram treatment on the longer term. This study compares doxapram to placebo and hypothesizes that doxapram will protect preterm infants from both invasive ventilation (and related lung disease) and AOP related oxygen shortage (and related impaired brain development).",[31,370],"Respiratory Insufficiency",[136,372,373],"Hypoxia","Doxapram","2024-04-03",{"date":376,"type":45},"2024-04-04",{"date":378,"type":45},"2020-06-15",{"date":380,"type":22},"2034-05-01",{"name":382,"class":52},"Erasmus Medical Center",24]