[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurodevelopmental-outcome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurodevelopmental-outcome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644802","bilirubin-thresholds-in-preterm-infants-on-neonatal-intensive-care-units-the-b-nice-trial-100644802",false,"NCT07674537","Bilirubin Thresholds in Preterm Infants on Neonatal Intensive CarE Units: The B-NICE Trial","B-NICE","Inclusion Criteria:\n\n* Gestational age at birth \\\u003C30+0 weeks.\n* Admission to a participating NICU within 24 hours after birth.\n* Parental consent according to the approved consent procedure\n\nExclusion Criteria:\n\n* Major congenital anomalies, excluding intraventricular hemorrhage, expected to affect survival or neurodevelopmental outcome.\n* Antenatal diagnosis of immune hemolytic disease of the fetus or newborn (such as RhD antagonism) requiring protocolized alternative management.","ALL","24 Weeks","29 Weeks",{"count":20,"type":21},680,"ESTIMATED","INTERVENTIONAL",[24],"NA","Rationale: Neonatal hyperbilirubinemia is highly prevalent in very preterm infants born \\\u003C30 weeks. Since 2008, uniform Dutch phototherapy thresholds for preterm infants have been used nationwide, largely based on consensus. Consequently, \\>80% of very preterm infants receive phototherapy for several days, accompanied by repeated blood sampling and reduced opportunities for skin-to-skin care. The corresponding UK National Institute for Health and Care Excellence (NICE) guideline applies higher (less strict) thresholds, which may reduce overtreatment, but comparative safety for very preterm infants has not been established in a randomized trial. The investigators hypothesize that using NICE thresholds is non-inferior to Dutch thresholds for survival without neurodevelopmental impairment (NDI) at two years' corrected age, while reducing treatment burden.\n\nObjective: Primary: To determine whether initiating phototherapy according to NICE thresholds is non-inferior to Dutch thresholds with regard to survival without NDI at two years' corrected age in infants born \\\u003C30 weeks of gestation. Secondary: To compare phototherapy exposure (incidence, duration and cumulative exposure) and monitoring burden (e.g., number of bilirubin blood samples, temperature instability, biomarkers of oxidative stress (subpopulation)), and to evaluate parent-infant outcomes (skin-to-skin contact time, parental stress\u002Fsatisfaction), and nursing workload (time dedicated to bilirubin-related care).\n\nStudy design: Nationwide multicenter, parallel-group, open-label randomized non-inferiority trial with 1:1 allocation, stratified by center and gestational age category (\\\u003C28 weeks and ≥28 weeks). Follow-up continues to the routine neurodevelopmental assessment at two years' corrected age. Planned project duration: 36 months.\n\nStudy population: Very preterm infants born \\\u003C30+0 weeks of gestation, admitted to a participating Dutch NICU within 24 hours after birth.\n\nIntervention: Bilirubin monitoring and phototherapy according to one of two threshold strategies: (1) current Dutch phototherapy thresholds (control) or (2) thresholds from the UK NICE guideline (intervention). Phototherapy is delivered using standard NICU devices.\n\nMain study parameters\u002Fendpoints: Primary endpoint: survival without NDI at two years' corrected age. NDI is defined as Bayley Scales of Infant and Toddler Development, fourth Edition, Dutch Version (BSID-IV-NL) cognitive and\u002For motor composite score \\\u003C85 and\u002For hearing impairment and\u002For visual impairment.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Both strategies reflect accepted standards of care with routine bilirubin monitoring. Incremental burden consists mainly of additional registration (phototherapy use, bilirubin sampling, skin-to-skin contact, temperature instability), parental questionnaires and, in selected centers, collection of stress-related biomarkers from urine, feces, or waste material from routine blood samples to explore the physiological impact of phototherapy. No biobanking for future unspecified research is planned. The investigators will also use routinely collected and stored monitor data to assess sleep (sleep-wake states and sleep fragmentation) in a subset of infants. Neurodevelopmental follow-up at two years corrected age is routine care in Dutch NICUs. Bilirubin levels above thresholds in both groups will be mitigated by routine monitoring and management according to this study protocol. The study is group-related because bilirubin management and potential neurotoxicity thresholds are specific to very preterm infants.",[27,28,29,30,31],"Neonatal Hyperbilirubinemia","Treatment Decisions","Neurodevelopmental Outcome","Phototherapy","Exchange Transfusion",[33,34],"neonatal jaundice","preterm infants \u003C 30 weeks GA","NOT_YET_RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":21},"2026-08-01",{"date":43,"type":21},"2029-11-01",{"name":45,"class":46},"University Medical Center Groningen","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":47},"100558026","admission-to-kangaroo-mother-care-kmc-ward-and-maternal-postpartum-depression-100558026","NCT06545760","Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression","Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled Trial","KMC PPD","Inclusion Criteria:\n\n-AIM #1-2 and #5\n\nMothers to newborns who are:\n\n1\\) Birthweight between 1000-2000gm 2) Admitted to the Women and Neonates Hospital-University Teaching Hospital Neonatal Intensive Care Unit (WNH-UTH NICU) (\\>48hrs) 3) Stable preterm eligible for continuing kangaroo mother care (KMC) in the NICU or NICU discharge 4) 16+ years of age (Mother) 5) Residing within Lusaka Province with no intensions to relocate in the coming 18 months\n\n* AIM #3\n\n  1. Parents (mothers and fathers) whose newborn has been enrolled in the study\n  2. Trusted family member or friend of the mother whose newborns is enrolled into the study\n  3. 16+ years of age (mothers and fathers)\n  4. 18+ years of age (family members)\n* AIM # 4:\n\n  1. Fathers whose newborn has been enrolled into the study\n  2. 16+ years of age (father)\n\nExclusion Criteria:\n\n* AIM #1-2 and #5\n\n  1. Mothers who are on treatment for depression and\u002For anxiety\n  2. Mothers who did not consent\n  3. Underage mothers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study\n* AIM #3\n\n  1\\) Family members of parents who do not consent to study participation\n* AIM # 4:\n\n  1. Fathers who are on treatment for depression and\u002For anxiety\n  2. Fathers who did not provide informed consent\n  3. Underage fathers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study","1 Day","89 Years",{"count":59,"type":21},1908,[24],"The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are:\n\n* Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting?\n* Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting?\n* What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting?\n* What is the prevalence of paternal depression in a low resource setting?\n* Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge?\n\nResearchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings.\n\nParticipants (infants) will:\n\n* At time of discharge from the NICU, when clinically stable, spend either \\\u003C 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge.\n* Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression.\n* Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.",[63,64,65,29,66],"Low Birth Weight","Kangaroo Mother Care","Postpartum Depression","Pre-Term",[68,64,69,70],"Low resource setting","Paternal depression","Cost-effectiveness","RECRUITING","2026-06-18",{"date":74,"type":39},"2026-06-22",{"date":76,"type":39},"2024-12-01",{"date":78,"type":21},"2027-09-30",{"name":80,"class":46},"University of Alabama at Birmingham",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100349133","30-or-60-oxygen-at-birth-to-improve-neurodevelopmental-outcomes-in-very-low-birthweight-infants-100349133","NCT03825835","30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants","Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial","HiLo","Inclusion Criteria:\n\n* Infants born at 23 0\u002F7 weeks to 28 6\u002F7 weeks' gestational age who will receive full resuscitation and are without major congenital abnormalities\n\nExclusion Criteria:\n\n* Infants who are outborn - initial resuscitation not performed at the study centre\n* Infants who are not born within the eligible gestational age range- this trial is specific to preterm infants\n* Infants who are born with a major congenital abnormality- congenital abnormalities may affect oxygenation or neurodevelopmental outcomes\n* Infants who will not receive full resuscitation at birth- these infants will not receive resuscitation","0 Minutes","10 Minutes",{"count":92,"type":21},1200,[24],"Preterm birth, or birth before 37 weeks' gestation, is increasingly common, occurring in 8 percent of pregnancies in Canada. Preterm birth is associated with many health complications, particularly when the birth happens before 29 weeks' gestation. At this gestational age, the lungs are not fully developed and it is not uncommon for infants to have problems breathing at the time of birth. One complication that can arise is when an infant stops breathing and needs to be resuscitated. When preterm babies need to be resuscitated doctors must take special care because of the small infant size and the immaturity of the brain and lungs. Oxygen is used to resuscitate babies who need it, but unfortunately there is disagreement about the best oxygen concentration to use. Oxygen concentration is important because both too much and too little oxygen can cause brain injury. This research aims to fill this knowledge gap by participating in an international clinical trial to compare the effects of resuscitating babies less than 29 weeks' gestational age with either a low oxygen concentration or a high oxygen concentration. The oxygen concentrations have been selected using the best available knowledge.\n\nThis will be a cluster randomized trial where each participating hospital will be randomized to either 30 or 60 percent oxygen for the recruitment of 30 infants, and afterwards randomized to the other group for the recruitment of another 30 infants. After the trial, the investigator will determine whether the babies resuscitated with low oxygen or those resuscitated with high oxygen have better survival and long-term health outcomes. This research fills a critical knowledge gap in the care of extremely preterm babies and will impact their survival both here in Canada and internationally.",[96,97,29],"Premature Infant","Respiratory Distress Syndrome in Premature Infant",[99,100,96,101],"Delivery Room","Resuscitation","Oxygen","2026-05-22",{"date":104,"type":39},"2026-05-26",{"date":106,"type":39},"2022-06-27",{"date":108,"type":21},"2029-12-30",{"name":110,"class":46},"University of Alberta",21]