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Trial · NCT03340727

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Days Between Randomization and Hospital DischargeRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAThe number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death.
PrimaryNumber of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-dischargeDischarge through 4 weeks post-dischargeNumber of sick visits related to apneic or apparent life-threatening events within first 4 weeks post-discharge MEASTYPE=SEC
SecondaryThe Number of Days to Physiologic Maturity After RandomizationRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days to physiologic maturity after randomization. Physiologic maturity is defined: 1. Temperature: out of the incubator for at least 48 hours with normal body temperature; 2. Feeding: oral feeding at a volume of at least 140 ml/kg for 48 hours or growing on less than 140 ml/kg/day for at least 48 hours; 3. Respiratory: apnea-free for at least 5 consecutive days. This outcome is censored at 48 weeks PMA
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 PMAThe number of days to when out of incubator for 48 hours: when maintained stable temp for 48 hrs. This outcome is censored at 48 weeks PMA
SecondaryThe Number of Days to Apnea/ Bradycardia Free for 5 Consecutive DaysRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAThe number of days to apnea/ bradycardia free for 5 consecutive days. This outcome is censored at 48 weeks PMA
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 PMAThe number of days oral feeds \>140 ml/kg/day or growing on less than 140 ml/kg/day for at least 48 hours. This outcome is censored at 48 weeks PMA
SecondaryPost-menstrual Age at DischargeRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAThe post-menstrual age of the infant at discharge censored at 48 weeks PMA and at time of transfer or death
SecondaryWeight Gain From Randomization Until StatusRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAWeight gain from randomization until status %(discharge up to 48 wks PMA, with censoring at time of transfer or death%).
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 PMAThe number of days after randomization until status that infant had at least two consecutive heart rates \>200 documented at least 3 hours apart
SecondaryTreatment for High Blood PressureRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMATreatment for high blood pressure initiated after randomization until status.
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 PMAThe number of episodes between randomization and status that infant was placed NPO for \>= 24 hours
SecondaryUse of Anti-reflux MedicationsRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAThe use of anti-reflux medications started between randomization and status
SecondaryNumber of Days That Significant Apnea/BradycardiaRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA
The number of days that significant apnea/bradycardia, as defined by documentation of infant receiving any of the following between randomization and status: open label caffeine, other methylxanthines, doxapram, CPAP or ventilatory support for apnea/bradycardia.
SecondaryAll-cause MortalityRandomization through hospital discharge, censored at time of transfer, death, or 48 wks PMAAll-cause mortality
SecondaryNumber of All-cause Readmissions Within First 4 Weeks Post-dischargeDischarge through 4 weeks post-dischargeNumber of all-cause readmissions within first 4 weeks post-discharge
SecondaryNumber of All-cause Readmissions Within Second 4 Weeks Post-discharge4 weeks through 8 weeks post-dischargeNumber of all-cause readmissions within second 4 weeks post-discharge
SecondaryNumber of All-cause Readmissions Within First 8 Weeks Post-dischargeDischarge through 8 weeks post-dischargeNumber of all-cause readmissions within first 8 weeks post-discharge
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-dischargeNumber of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 4 weeks post-discharge
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-dischargeNumber of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within second 4 weeks post-discharge
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-dischargeNumber of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 8 weeks post-discharge

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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