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Trial · NCT01353313

Outcomes40

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYSurvival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD)From day of randomization to 36 weeks post menstrual ageThe analysis population includes all randomized infants with available data at hospital discharge.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYSurvival Without Moderate/Severe Neurodevelopmental Impairment (NDI)From day of randomization to 22-26 months corrected ageThe analysis population includes all randomized infants with available data at the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Successful ExtubationFrom day of randomization to day 14 post randomizationThe analysis population includes all randomized infants with available data at hospital discharge.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTotal Deaths Before DischargeFrom day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthThe analysis population includes all randomized infants with available data at hospital discharge.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Bronchopulmonary Dysplasia (BPD) Grade at 36 Weeks Postmenstrual AgeAt 36 weeks postmenstrual ageThe analysis population includes all randomized infants with available data at hospital discharge.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDays of Mechanical Ventilation to 36 Weeks Postmenstrual Age (PMA)From birth to 36 weeks postmenstrual ageThe analysis population includes all randomized infants with available data at hospital discharge.DaysMEDIAN
SECONDARYDuration of Oxygen Supplementation up to StatusFrom birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birthThe analysis population includes all randomized infants with available data who survived up to hospital discharge.DaysMEDIAN
SECONDARYLength of Hospital Stay in Days Among Survivors to DischargeFrom birth up to one yearThe analysis population includes all randomized infants with available data at hospital discharge.DaysMEDIAN
SECONDARYNumber of Participants With Dexamethasone Given Before 36 Weeks Postmenstrual Age (PMA)From birth to 36 weeks postmenstrual ageThe analysis population includes all randomized infants with available data at hospital discharge.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Normal/Mild, Moderate or Severe/Profound NDIAt 22-26 months corrected ageThe analysis population includes all randomized infants with available data who survived up to the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Gross Motor Function Greater Than or Equal to Level 2At 22-26 months corrected ageThe analysis population includes all randomized infants with available data who survived up to the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Moderate-severe Cerebral PalsyAt 22-26 months corrected ageThe analysis population includes all randomized infants with available data who survived up to the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Severe Hearing Impairment (by Report)At 22-26 months corrected ageThe analysis population includes all randomized infants with available data who survived up to the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With no/Some Functional VisionAt 22-26 months corrected ageThe analysis population includes all randomized infants with available data who survived up to the two-year followup.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYWeight Growth Measure Following Extremely Preterm BirthAt 36 weeks post-menstrual ageThe analysis population includes all randomized infants with available data between 35 and 37 weeks at discharge.Z-scoreMEAN
SECONDARYFollow-up Weight Growth Measure Following Extremely Preterm BirthAt 22-26 months corrected ageThe analysis population includes all randomized infants with available data between 18 and 30 months at follow-up.Z-scoreMEAN
SECONDARYLength Growth Measure Following Extremely Preterm BirthAt 36 weeks post-menstrual ageThe analysis population includes all randomized infants with available data between 35 and 37 weeks at discharge.Z-scoreMEAN
SECONDARYFollow-up Length Growth Measure Following Extremely Preterm BirthAt 22-26 months corrected ageThe analysis population includes all randomized infants with available data between 18 and 30 months at follow-up.Z-scoreMEAN
SECONDARYHead Circumference Growth Measure Following Extremely Preterm BirthAt 36 weeks post-menstrual ageThe analysis population includes all randomized infants with available data between 35 and 37 weeks at discharge.Z-scoreMEAN
SECONDARYFollow-up Head Circumference Growth Measure Following Extremely Preterm BirthAt 22-26 months corrected ageThe analysis population includes all randomized infants with available data between 18 and 30 months at follow-up.Z-scoreMEAN

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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