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Trial · NCT01958320

Outcomes12

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits)through hospital discharge (approximately 6 months unless death occurs first)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDuration of Gavage Feeding Assistanceup to 20 weeks of agedaysMEDIAN
SECONDARYIncidence of Necrotizing Enterocolitis or Spontaneous Perforationthrough hospital discharge (approximately 6 months unless death occurs first)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYthe Average Daily Weight Gainup to 20 weeks of agegm/kg/dayMEAN
SECONDARYIncidence of Bronchopulmonary Dysplasia or Deathdetermined between 36-37 weeks corrected ageParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYIncidence of Deaththrough hospital discharge (approximately 6 months unless death occurs first)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYthe Incidence of Persistent Moderate-to-large PDA Shunt 10 Days After Enrollment10 days after enrollmentParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYthe Incidence of Rescue Treatment Eligibility Criteria Metthrough hospital discharge (approximately 6 months unless death occurs first)ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Infants Receiving ≥ 14 Days of Diuretic Treatmentthrough hospital discharge (approximately 6 months unless death occurs first)ParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDNumber of Infants Who Received Dopamine for ≥3 Daysthrough hospital discharge (approximately 6 months unless death occurs first)ParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDIncidence of Bacteremiathrough hospital discharge (approximately 6 months unless death occurs first)ParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDIncidence of Pulmonary Hemorrhagethrough hospital discharge (approximately 6 months unless death occurs first)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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