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Trial · NCT03340727

Outcomes22

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Days Between Randomization and Hospital DischargeRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.daysMEDIAN
SECONDARYThe Number of Days to Physiologic Maturity After RandomizationRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.daysMEDIAN
SECONDARYThe Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 HrsRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.daysMEDIAN
SECONDARYThe Number of Days to Apnea/ Bradycardia Free for 5 Consecutive DaysRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.daysMEDIAN
SECONDARYThe Number of Days to Oral Feeds >140 ml/kg/Day or Growing on Less Than 140 ml/kg/Day for at Least 48 HoursRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.daysMEDIAN
SECONDARYPost-menstrual Age at DischargeRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.weeksMEAN
SECONDARYWeight Gain From Randomization Until StatusRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.grams per dayMEAN
SECONDARYThe Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours ApartRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.daysMEDIAN
SECONDARYTreatment for High Blood PressureRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYThe Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 HoursRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.episodesMEDIAN
SECONDARYUse of Anti-reflux MedicationsRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Days That Significant Apnea/BradycardiaRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.daysMEDIAN
SECONDARYAll-cause MortalityRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of All-cause Readmissions Within First 4 Weeks Post-dischargeDischarge through 4 weeks post-dischargeAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.count of readmissionsMEDIAN
SECONDARYNumber of All-cause Readmissions Within Second 4 Weeks Post-discharge4 weeks through 8 weeks post-dischargeAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.count of readmissionsMEDIAN
SECONDARYNumber of All-cause Readmissions Within First 8 Weeks Post-dischargeDischarge through 8 weeks post-dischargeAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.count of readmissionsMEDIAN
SECONDARYNumber of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 4 Weeks Post-dischargeDischarge through 4 weeks post-dischargeAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.count of sick visitsMEDIAN
SECONDARYNumber of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 4 Weeks Post-discharge4 weeks through 8 weeks post-dischargeAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.count of sick visitsMEDIAN
SECONDARYNumber of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 8 Weeks Post-dischargeDischarge through 8 weeks post-dischargeAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.count of sick visitsMEDIAN
PRIMARYNumber of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-dischargeDischarge through 4 weeks post-dischargeAn intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.count of apnea visitsMEDIAN

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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