[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-newborn-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-newborn-diseases":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,86,121,159,197,228,252,283],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":46,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100569405","advanced-wireless-sensors-for-neonatal-care-in-the-delivery-room-100569405",false,"NCT06693817","Advanced Wireless Sensors for Neonatal Care in the Delivery Room","Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study","AWARD","Inclusion criteria:\n\n1. Newborns ≥35 weeks (gestational age)\n2. Newborns determined to be clinically stable at delivery\n3. Newborns with no skin abnormalities\n\nExclusion criteria:\n\n1. Newborns ≤ 35 weeks (gestational age)\n2. Newborns determined to not be clinically stable at delivery\n3. Newborns with Skin abnormalities",true,"ALL","35 Weeks","42 Weeks",{"count":22,"type":23},600,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to:\n\n1. Assess feasibility\n2. Evaluate safety\n3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Sudden Unexplained Infant Death","Apnea of Newborn","Newborn Morbidity","Newborn Asphyxia","Birth Outcome, Adverse","Birth Asphyxia","Pregnancy Related","Newborn; Vitality","ECG Electrode Site Reaction","Infant ALL","Infant Death","Infant, Newborn, Diseases","Infant Apnea","Infant Conditions","Parents","Delivery Problem for Fetus","Delivery Complication",[47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"Delivery Room","Newborn","Neonatal Resuscitation","Wireless Technology","Vital Sign Monitoring","Sudden Unexplained Post-Natal Collapse","SUPC","Obstetrical Center","Obstetrics","Neonate","Birth","Birthing Center","C-Section","Vaginal Delivery","Sensors","Heart Rate (HR)","Respiratory Rate (RR)","Blood Oxygen Saturation (SpO2)","Skin Temperature (Tskin)","Pulse Rate (PR)","International","Low-Income","Middle-Income","High-Income","Golden Hour","Post-Birth","RECRUITING","2026-05-05",{"date":76,"type":77},"2026-05-08","ACTUAL",{"date":79,"type":77},"2025-04-08",{"date":81,"type":23},"2027-12-30",{"name":83,"class":84},"Guilherme Sant'Anna, MD","OTHER",5,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":17,"sex":18,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":24,"phases":97,"briefSummary":98,"conditions":99,"keywords":106,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":120},"100568106","neonatal-platelet-transfusion-threshold-trial-100568106","NCT06676904","Neonatal Platelet Transfusion Threshold Trial","NeoPlaTT","Inclusion Criteria:\n\n* Gestational age of 23 0\u002F7 to 26 6\u002F7 weeks\n* Postnatal age of \\\u003C 48 hours\n\nExclusion Criteria:\n\n* Comfort care or withdrawal of care planned\n* Neonatal alloimmune thrombocytopenia or suspected\u002Fconfirmed congenital platelet or bleeding disorder\n* Receipt of platelet transfusion\n* No receipt of Vitamin K\n* Parents\u002Fguardian decline consent","1 Hour","48 Hours",{"count":96,"type":23},2433,[26],"The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0\u002F7 to 26 6\u002F7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0\u002F7 weeks' postmenstrual age (PMA).",[100,101,102,40,103,104,105],"Thrombocytopenia","Neonatal","Platelet Transfusion","Infant, Extremely Low Birth Weight","Infant, Small for Gestational Age","Thrombosis",[107,108,109],"platelet transfusion","neonatal","thrombosis","2026-03-24",{"date":112,"type":77},"2026-03-25",{"date":114,"type":77},"2025-06-13",{"date":116,"type":23},"2031-04-30",{"name":118,"class":119},"NICHD Neonatal Research Network","NETWORK",20,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":18,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":24,"phases":132,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100563231","phase-1-pkpd-of-digoxin-in-infants-with-svhd-100563231","NCT06613477","PK\u002FPD of Digoxin in Infants With SVHD","Pharmacokinetics and Pharmacodynamics of Digoxin in Infants With Single Ventricle Heart Disease","Digoxin R01","Inclusion Criteria:\n\n1. Diagnosis of single ventricle congenital heart disease\n2. Status post-surgical or hybrid stage 1 palliation but prior to surgical stage 2 palliation\n3. Age ≤ 30 days of life at time of stage 1 palliation\n4. Age \\\u003C 6 months at time of enrollment\n5. Require treatment with enteral digoxin per their treating medical provider\n6. Informed consent obtained from parent(s) or legal guardian(s)\n\nExclusion Criteria:\n\n1. Gestational age at birth \\\u003C35 weeks\n2. Serum creatinine \\> 2 mg\u002FdL at enrollment\n3. Diagnosis of second degree or higher atrioventricular conduction block at enrollment\n4. Diagnosis of clinically significant sinus bradycardia requiring intervention at enrollment\n5. Known hypersensitivity to digoxin or other forms of digitalis\n6. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) at enrollment\n7. Received digoxin prior to enrollment\n8. Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study","30 Days","6 Months",{"count":120,"type":23},[133,134],"PHASE1","PHASE2","The primary participant will be an infant with single ventricle heart disease.\n\nThis is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in pediatric cardiac intensive care units is processed by their bodies and how it may help their cardiac function.\n\nThe investigators will collect blood or will collect blood samples when bloodwork is checked as part of regular care (\"opportunistic\"). The investigators will also collect information from medical records.\n\nBeing part of this study will not change treatment plan or medications. The risks of this study include loss of confidentiality and risks associated with having blood drawn. The study team will make every effort to minimize these risks.",[137,42,40,138],"Single-ventricle","Infant, Premature, Diseases",[140,141,142,143,144,145,146,147,148],"Infants","SVD","SVHD","Single Ventricle","Digoxin","Pharmacokinetics","Pharmacodynamics","PK","PD","2026-01-28",{"date":151,"type":77},"2026-01-30",{"date":153,"type":77},"2024-10-10",{"date":155,"type":23},"2026-11-30",{"name":157,"class":84},"Duke University",2,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":18,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":24,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100535750","phase-4-treatment-of-gastroesophageal-reflux-disease-in-infants-100535750","NCT06255886","Treatment of Gastroesophageal Reflux Disease in Infants","Treatment of Gastroesophageal Reflux Disease in Infants- a Randomized Controlled Trial","Inclusion Criteria:\n\n* Infants diagnosed with gastroesophageal reflux disease (GERD)\n* Age \\\u003C 1 year at the time of referral\n* Age \\>1 month at start of treatment\n* At least 3 reflux episodes\u002Fdaily in average\n* At least one of following troublesome symptoms are present: Crying of unknown reason, discomfort\u002Firritability, problems gaining weight\u002F weightloss, rejects the breast or bottle, apnea, back-arching.\n\nExclusion Criteria:\n\n* Children with diagnosed or suspected syndrome \u002Fgenetic disorder\n* Congenital malformations (minor deformities are excepted)\n* Abdominal surgery\n* Metabolic disease\n* Treatment with proton pump inhibitor within the last week\n* Allergy for proton pump inhibitors\n* Allergy for cow milk protein\n* Infants on Cow's milk free diet","1 Month","1 Year",{"count":169,"type":23},96,[171],"PHASE4","Gastroesophageal reflux disease in infants is not fully understood. Infants are prescribed medical treatments that may not be effective or that contribute to adverse side effects and lead to concerns and expenses for the parents and healthcare system. Current guidelines recommend cow-milk-protein free diet as a first-line treatment, but these recommendations are based on weak evidence. This study investigate the efficacy of a cow-milk-protein free diet compared to treatment with a proton pump inhibitor (omeprazole)",[174,40],"Gastroesophageal Reflux",[176,140,177,178,179,180,181,182,183,184,185,186],"Reflux","GERD","GER","GORD","GOR","Cow milk protein","Bovine milk protein","CMP","Proton pump inhibitor","PPI","Omeprazole","2025-11-17",{"date":189,"type":77},"2025-11-20",{"date":191,"type":77},"2025-10-27",{"date":193,"type":23},"2026-12-26",{"name":195,"class":84},"Odense University Hospital",3,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":18,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":24,"phases":209,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":227},"100508968","phase-3-safeguarding-the-brain-of-our-smallest-children-iiiv-safeboosc-iiiv-100508968","NCT05907317","Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)","Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns","SafeBoosC-IIIv","Inclusion Criteria:\n\n* Gestational age more than or equal to 28+0\n* Postnatal age less than 28 days\n* Expected to receive invasive mechanical ventilation (intubation) for at least 24 hours, as judged by the physician intending to randomise\n* Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method\n* A cerebral oximeter available so monitoring can be started within six hours after initiation of invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Suspicion of or confirmed brain injury or disorder (e.g. severe hypoxic-ischemic encephalopathy, intraventricular haemorrhage grade 3 or 4, cerebral malformation, genetic or metabolic disease)\n* Suspicion or diagnosis of congenital heart malformations likely to require surgery","0 Days","28 Days",{"count":208,"type":23},1610,[210],"PHASE3","The objective of the SafeBoosC-IIIv trial is to assess benefits and harms of cerebral oximetry in newborns receiving invasive mechanical ventilation. The hypothesis is that:\n\ni. Cerebral oximetry added to usual care versus usual care alone in newborns receiving invasive mechanical ventilation will increase the number of hospital-free days within 90 days of randomisation.\n\nii. The intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and\u002For increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.",[213,40],"Hypoxia",[215,216,217],"Near-infrared spectroscopy","Randomised clinical trial","Mechanical ventilation","2025-04-23",{"date":220,"type":77},"2025-04-25",{"date":222,"type":77},"2025-04-11",{"date":224,"type":23},"2029-02-01",{"name":226,"class":84},"Copenhagen Trial Unit, Center for Clinical Intervention Research",1,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":18,"minAge":166,"maxAge":167,"enrollmentInfo":235,"targetDuration":4,"studyType":24,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":227},"100582406","effect-of-chest-physiotherapy-on-clinical-outcome-of-infants-with-bronchiolitis-100582406","NCT06862895","Effect of Chest Physiotherapy on Clinical Outcome of Infants With Bronchiolitis","Effect of Chest Physiotherapy Educational Program on Mother's Knowledge, Practice and Clinical Outcomes of Infants With Bronchiolitis","Inclusion Criteria:\n\n* 1\\. Mothers of infants diagnosed with bronchiolitis. 2. Presence of crackle on auscultation.\n\nExclusion Criteria:\n\n1. Children with contraindication of chest physiotherapy (ex. Fracture, recent surgery)\n2. Children who intubated and admitted to Intensive Care Unit (ICU).",{"count":236,"type":23},40,[26],"The goal of clinical trial study is to evaluate effect of chest physiotherapy educational on mother's knowledge, practice and clinical outcomes of infants aged less than 12 months diagnosed with bronchiolitis by physician\n\nThe main questions aims to answer:\n\n* Does chest physiotherapy improve clinical outcomes of infants with bronchiolitis?\n* Does educational program improve mothers knowledge and practice regarding chest physiotherapy?\n\nResearcher compare two groups one receive routine hospital care (control group) other receive chest physiotherapy applied by mothers in addition to routine hospital care and will be followed up for 3 days",[240,40,241,242],"Bronchiolitis","Chest Physiotherapy","Educational Program","2025-03-03",{"date":245,"type":77},"2025-03-06",{"date":247,"type":77},"2025-01-01",{"date":249,"type":23},"2025-09-01",{"name":251,"class":84},"Hawler Medical University",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":259,"minAge":260,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":263,"phases":4,"briefSummary":264,"conditions":265,"keywords":269,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":158},"100536644","increasing-neonatal-hiv-test-and-treat-to-maximize-the-long-term-impact-on-infant-health-and-novel-infant-antiretroviral-treatment-100536644","NCT06267508","Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment","LIFE2Scale","Inclusion Criteria:\n\n1. Voluntary and informed consent of the mother for her own study participation (if applicable);\n2. Voluntary and informed consent of the legal guardian of the child for participation of the child in the study;\n3. Mothers\u002Flegal guardians ≥18 years of age;\n4. Documented maternal HIV infection;\n5. Willingness to consent to HIV testing for the child and herself (or just her child); and\n6. Willingness to consent to active tracing including home tracing.\n\n   Exclusion Criteria:\n7. Deficiency in the mother, rendering it difficult, if not impossible, for her or her infant to take part in the study or understand the information provided to her.\n8. Having delivered more than 72h (3 days) ago;\n9. Prisoners;\n10. Women presenting with an emergency requiring immediate medical assistance if not resolved at study inclusion;\n11. Stillbirths;\n12. Infant requiring emergency care (e.g. immediate or rapid occurring life threatening conditions, resuscitation, prolonged obstetric related intensive care, severe jaundice) or born with severe malformation;\n13. If within the discretion of the investigator based on recommendation of the gynaecologist or paediatrician in charge study participation would possibly add not acceptable risk or burden to the mother or infant (e.g. significant congenital malformation, health deficiencies, very low birth weight less than 1500g); or\n14. Unlikely to comply with protocol as judged by the principal investigator or his designate","FEMALE","18 Years",{"count":262,"type":23},6000,"OBSERVATIONAL","This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system.",[266,267,39,268,40],"Vertical Human Immunodeficiency Virus Transmission","HIV Infection Pediatric","Infant Morbidity",[270,271,272,273],"Prevention of Vertical HIV Transmission (PVHT)","Infant HIV Prophylaxis","Early Infant HIV Diagnosis","Infant Antiretroviral Treatment","2024-11-14",{"date":276,"type":77},"2024-11-18",{"date":278,"type":77},"2024-04-30",{"date":280,"type":23},"2025-12",{"name":282,"class":84},"Michael Hoelscher",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":24,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":227},"100558932","prophylactic-surfactant-by-thin-endotracheal-catheter-for-preterm-infants-at-birth-the-protect-trial-100558932","NCT06557551","Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial","proTeCt","Inclusion criteria\n\n* Infants of any sex born before 28 weeks of gestation\n* Clinicians plan to provide intensive care\n* Consent for their participation provided by parent(s)\u002Fguardian(s) before their birth\n\nExclusion criteria\n\n• Major congenital anomalies (e.g. upper airway anomaly, diaphragmatic hernia, gastroschisis, exomphalos major, intestinal atresias, open neural tube defect, aneuploidy, cardiac lesions other than ASD\u002FPFO\u002FVSD\u002FPDA )","30 Minutes",{"count":292,"type":23},164,[26],"The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life.\n\nThe main question it aims to answer is:\n\nDo fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth?\n\nExtremely premature babies who are receiving breathing support through a face mask will either:\n\n* Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or\n* Continue on face mask breathing support.\n\nAll babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.",[40,296,297,298],"Prematurity","Prematurity; Extreme","Respiratory Distress Syndrome in Premature Infant","2024-10-08",{"date":301,"type":77},"2024-10-15",{"date":303,"type":77},"2024-08-19",{"date":305,"type":23},"2027-02-28",{"name":307,"class":84},"University College Dublin"]