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Trial · NCT00955487

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCombined Endpoint of Bronchopulmonary Dysplasia (BPD) or MortalityWeek 36 or earlier, if participants are discharged from the hospitalNumber of participants that developed bronchopulmonary dysplasia and/or that died
PrimaryCombined Endpoint of Bronchopulmonary Dysplasia (BPD) or Mortality Stratified by Birth WeightRandomization to dischargeNumber of participants that developed bronchopulmonary dysplasia and/or that died, stratified by birth weight (grams)
SecondarySeverity of Bronchopulmonary Dysplasia (BPD)36 weeks corrected gestational ageAssessment of the severity of BPD as defined by the oxygen reduction test
SecondaryNeed for Mechanical VentilationAnytime after randomization up to 36 weeks corrected gestational ageNumber of participants who required endotracheal intubation and mechanical ventilation
SecondaryTotal Ventilation DaysAfter randomization up until hospital dischargeOf those participants who required mechanical ventilation, the total number of days receiving ventilation
SecondaryNecrotizing Enterocolitis (NEC)After randomization through hospital dischargeNumber of participants diagnosed with necrotizing enterocolitis
SecondarySymptomatic PDA Requiring Medical TreatmentFrom randomization until dischargeNumber of participants with a symptomatic PDA that required medical treatment
SecondarySymptomatic PDA Requiring Surgical LigationRandomization through dischargeNumber of participants with symptomatic PDA that required surgical ligation
SecondaryThreshold Retinopathy of Prematurity (ROP)Randomization to dischargeThreshold ROP defined as requiring interventional therapy
SecondarySevere Intracranial HemorrhageRandomization to dischargeNumber of participants that developed severe intracranial hemorrhage (grade 3-4)
SecondarySepsisRandomization to dischargeNumber of participants that developed sepsis
OtherDays in HospitalFrom birth to hospital dischargeLength of stay of participants

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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