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Trial · NCT03169881

Outcomes14

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYBayley III Composite Cognitive Score22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlierThe analysis population includes all randomized infants with available data up to the two-year followup.score on a scaleMEAN
SECONDARYNumber of Transfusions Per InfantBirth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)The analysis population includes all randomized infants with available data during the initial hospitalization.TransfusionsMEAN
SECONDARYTotal Volume of Transfusions Per InfantBirth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)The analysis population includes all randomized infants that were ever transfused.mLMEAN
SECONDARYNumber of Donor Exposures Per InfantBirth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)The analysis population includes all randomized infants with available data during the initial hospitalization.DonorsMEAN
SECONDARYHematocritat 2 and at 7 weeks in the studyThe analysis population includes all randomized infants with available data during the initial hospitalization.Percent of blood volume made up of RBCsLEAST_SQUARES_MEAN
SECONDARYRed Cell Massat 2 and at 7 weeks in the studyThe analysis population includes all randomized infants with available data during the initial hospitalization.mLLEAST_SQUARES_MEAN
SECONDARYNecrotizing Enterocolitis, Bells Stage >=2 With SurgeryBirth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)The analysis population includes all randomized infants with available data during the initial hospitalization.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYBronchopulmonary Dysplasia Grades 2 or 3At 36 weeks postmenstrual ageThe analysis population includes all randomized infants with available data during the initial hospitalization.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 94 days)The analysis population includes all randomized infants with available data during the initial hospitalization.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYIntraventricular Hemorrhage Grade I+Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)The analysis population includes all randomized infants with available data during the initial hospitalization.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYLength of Hospital StayAt initial hospital discharge or at death if it occurs earlier (a median of 94 days), assessed up to one year of life.The analysis population includes all randomized infants with available data during the initial hospitalization.DaysMEAN
SECONDARYDeathBirth, through the 22-26 months corrected age follow-up window, which corresponds to a median of 29 months calendar age in the analysis populationThe analysis population includes all randomized infants with available data up to the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNeurodevelopmental ImpairmentAt 22-26 months corrected age (a median of 25 months corrected age)The analysis population includes all randomized infants with available data at the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAny Cerebral PalsyAt 22-26 months corrected age (a median of 25 months corrected age)The analysis population includes all randomized infants with available data at the two-year followup.ParticipantsCOUNT_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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