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Trial · NCT01702805

Outcomes30

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYDeath or Neurodevelopmental ImpairmentBirth to 22-26 months corrected ageThe analysis population includes all randomized infants with available data for death and/or neurodevelopmental impairment.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYDeathBirth to 22-26 months corrected ageThe analysis population includes all randomized infants with available vital status.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNeurodevelopmental Impairmentat 22-26 months corrected ageThe analysis population includes all randomized infants with available data for neurodevelopmental impairment.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYCognitive Delayat 22-26 months corrected ageThe analysis population includes all randomized infants with available data at the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYModerate or Severe Cerebral Palsyat 22-26 months corrected ageThe analysis population includes all randomized infants with available data at the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYSevere Vision Impairmentat 22-26 months corrected ageThe analysis population includes all randomized infants with available data at the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYSevere Hearing Impairmentat 22-26 months corrected ageThe analysis population includes all randomized infants with available data at the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSurvival to Discharge Without Severe ComplicationsBirth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)The analysis population includes all randomized infants with available data up to hospital discharge or death.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYBronchopulmonary Dysplasia, Diagnosed on the Basis of the Need for Supplemental Oxygen After a Standardized Oxygen Reduction Test at 36 Weeks of Postmenstrual Ageat 36 weeks postmenstrual ageThe analysis population includes all randomized infants with available data at 36 weeks postmenstrual age.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYRetinopathy of Prematurity Stage >=3 or Treatment for That Condition ReceivedBirth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)The analysis population includes all randomized infants with available data up to hospital discharge or death.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYGrade 3 or 4 Intraventricular Hemorrhage, Cystic Periventricular Leukomalacia, or Ventriculomegaly Diagnosed on Ultrasonographic ExaminationBirth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)The analysis population includes all randomized infants with available data up to hospital discharge or death.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNecrotizing Enterocolitis, Bell's Stage >=2Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)The analysis population includes all randomized infants with available data up to hospital discharge or death.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Transfusions Per InfantBirth, up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual age (PMA)The analysis population includes all randomized infants with available data up to death, hospital discharge, or 36 weeks PMA, whichever occurs firstTransfusionsMEAN
SECONDARYWeight-for-age: Z-scoreat 36 weeks postmenstrual age or initial hospital discharge, whichever occurs firstThe analysis population includes all randomized infants with available data at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first.Z-scoreMEAN
SECONDARYLength-for-age: Z-scoreat 36 weeks postmenstrual age or initial hospital discharge, whichever occurs firstThe analysis population includes all randomized infants with available data at 36 weeks postmenstrual age or initial hospital discharge, whichever occurs first.Z-scoreMEAN
SECONDARYHead Circumference-for-age: Z-scoreat 36 weeks postmenstrual age or initial hospital discharge, whichever occurs firstThe analysis population includes all randomized infants with available data at 36 weeks postmenstrual age or at initial hospital discharge, whichever occurs first.Z-scoreMEAN
SECONDARYPostmenstrual Age at Final Trachael Extubationat final trachael extubation, assessed from birth up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual ageThe analysis population includes all randomized infants with available data on trachael extubation.WeeksMEAN
SECONDARYPostmenstrual Age at Final Caffeine Dose in Infants Who Received Caffeine Treatmentat final caffeine dose, assessed from birth up to the earliest of: death, hospital discharge, or 36 weeks postmenstrual ageThe analysis population includes all randomized infants with available data on caffeine treatment.WeeksMEAN
SECONDARYLength of Stayat initial hospital discharge or at death if it occurs earlier (a median of 97 days)The analysis population includes all randomized infants with available data up to the initial hospital discharge or death, whichever occurs first.DaysMEDIAN
SECONDARYTime to Full Enteral Feedingat first full enteral feeding, assessed from birth up to initial hospital discharge or to death if it occurs earlier (a median of 97 days)The analysis population includes all randomized infants with available data on enteral feeding.DaysMEDIAN

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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