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Trial · NCT01318278

Outcomes13

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life24 hours of life
This outcome is only reportable in the two treatment groups as it evaluates the response to treatment of hypotension in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.
participantsNUMBER
SECONDARYHeart Rate Change From Baseline96 hours or until hypotension completely resolved and medications stopped
This outcome is only reportable in the two treatment groups as it evaluates the change in heart rate in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.
beats per minuteMEAN
SECONDARYAcid-base Status96 hours or until hypotension resolved and medication completely stoppedTreatment groups during study drug administration. Comparison group during first 96 hours of life. For all- only arterial gasespHMEAN
SECONDARYHyponatremia96 hours or until medication completely stoppedparticipantsNUMBER
SECONDARYUrine Output96 hours or until hypotension resolved and medication completely stoppedml/kg/hrMEAN
SECONDARYEvidence of Ischemic Changes96 hours or until medication completely stoppedparticipantsNUMBER
SECONDARYNecrotizing Enterocolitisuntil hospital discharge, up to 12 weeksparticipantsNUMBER
SECONDARYVentilator DaysUntil hospital discharge, up to 15 monthsdaysMEDIAN
SECONDARYPresence of Patent Ductus Arteriosus (PDA)until hospital discharge, up to 12 weeksparticipantsNUMBER
SECONDARYGrade 3 Intraventricular Hemorrhage or Worse on Head UltrasoundUntil hospital discharge, up to 15 monthsparticipantsNUMBER
SECONDARYRetinopathy of Prematurity Stage 3 or HigherUntil hospital discharge, up to 15 monthsparticipantsNUMBER
SECONDARYPresence of Bronchopulmonary Dysplasia (BPD)36 weeks postmenstrual ageparticipantsNUMBER
SECONDARYAll Cause Mortalityadmission to hospital discharge, up to 15 monthsparticipantsNUMBER

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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