[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644802":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":55,"collaborators":57,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":98,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Dutch phototherapy and exchange thresholds (control)","ACTIVE_COMPARATOR","Current phototherapy and exchange thresholds according to the Dutch national guideline, which are lower than the UK (NICE) thresholds after the first days.",[13,14],"Other: Phototherapy","Other: Exchange Transfusion",{"label":16,"type":17,"description":18,"interventionNames":19},"United Kingdom phototherapy and exchange thresholds (NICE guideline; intervention)","EXPERIMENTAL","Current phototherapy and exchange thresholds according to NICE guideline, which are higher than the Dutch thresholds after the first days.",[13,14],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Phototherapy","This study is a nationwide multicenter, parallel-group, open-label randomized non-inferiority trial conducted in Dutch neonatal intensive care units (NICUs) within the Neonatology Network Netherlands (N3). Eligible infants will be randomized 1:1 to bilirubin management using either the current Dutch phototherapy and exchange thresholds (control) or the higher thresholds from the UK NICE guideline (intervention).\n\nThe trial is open-label because threshold application is embedded in routine clinical decision-making.",[9,16],null,{"type":6,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Exchange Transfusion",[9,16],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Christian V Hulzebos, MD, PhD, Assistent Professor","CONTACT","+31-503612488","c.v.hulzebos@umcg.nl",{"name":36,"role":32,"phone":33,"phoneExt":25,"email":37},"Peter H Dijk, MD, PhD","p.h.dijk@umcg.nl",[39],{"facility":40,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Beatrix Children's Hospital, University Medical Center Groningen","Groningen","Provincie Groningen","9713GZ","Netherlands","NL",{"type":47,"coordinates":48},"Point",[49,50],6.56667,53.21917,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":25,"phoneExt":25,"email":25},"Christian V Hulzebos",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[58,60,62,64,66,68,70,72],{"name":59,"class":6},"Isala",{"name":61,"class":6},"Maastricht University Medical Center",{"name":63,"class":6},"Leiden University Medical Center",{"name":65,"class":6},"Maxima Medical Center",{"name":67,"class":6},"UMC Utrecht",{"name":69,"class":6},"Erasmus Medical Center",{"name":71,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"name":73,"class":6},"University Medical Center Nijmegen","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":85,"type":86},680,"ESTIMATED","INTERVENTIONAL",[89],"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.",[92,93,94,22,27],"Neonatal Hyperbilirubinemia","Treatment Decisions","Neurodevelopmental Outcome",[96,97],"neonatal jaundice","preterm infants \u003C 30 weeks GA","NOT_YET_RECRUITING","2026-06-24",{"date":101,"type":102},"2026-06-29","ACTUAL",{"date":104,"type":86},"2026-08-01",{"date":106,"type":86},"2029-11-01",{"name":5,"class":6},1]