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Trial · NCT07447739

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryThe rate of successful respiratory weaningFrom initiation of treatment until 7 days after treatment completion
* Defined by a 20% reduction from baseline in mean airway pressure or FiO2 if patient remains intubated * or successful extubation and maintenance of extubation for 7 days after betamethasone completion
SecondaryThe incidence of adverse eventsDuring betamethasone administration period (5 days)The incidence of hyperglycemia (\>150 mg/dL) during administration period
SecondaryThe incidence of adverse eventsFrom the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes firstThe incidence of hypertension (requiring medication) anytime during hospitalization
SecondaryThe incidence of adverse eventsDuring betamethasone administration period and up to 72 hours after completion of betamethasone administrationThe incidence of gastrointestinal perforation (during or less than 72 hours after treatment completion)
SecondaryThe incidence of adverse eventsFrom the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes firstThe incidence of culture-positive infection that requires treatment
SecondaryThe incidence of mortbidities associated with extreme prematurityFrom admission until the time of NICU discharge or 52 weeks of age, whichever comes firstThe incidence of * Severe intraventricular hemorrhage * Periventricular leukomalacia * Retinopathy of prematurity * Hemodynamically signifcant patent ductus arteriosus
SecondaryAnthropometric measurementsFrom discharge to 24 months corrected age
weight at the time of discharge (in grams and percentile rank using Fenton growth curve 2013 for gestational age) and at 24 months corrected age (in grams and their corresponding percentile rank for age using CDC growth chart 0-36 months)
SecondaryAnthropometric measurementsFrom discharge to 24 months corrected age
length at the time of discharge (in centimeters and percentile rank using Fenton growth curve 2013 for gestational age) and at 24 months corrected age (in centimeters and their corresponding percentile rank for age using CDC growth chart 0-36 months)
SecondaryAnthropometric measurementsFrom discharge to 24 months corrected age
Head circumference at the time of discharge (in centimeters and percentile rank using Fenton growth curve 2013 for gestational age) and at 24 months corrected age (in centimeters and their corresponding percentile rank for age using CDC growth chart 0-36 months)
SecondaryNeurodevelopmental outcomesat 24 months corrected age
the results of evaluation utilizing the Bayley Scales of Infant Development. The minimum score is 40 and the maximun score is 160, with a higher score represents better outcome. The score of 100 is average, and 15 points represents 1 standard deviation either way.
SecondaryBronchopulmonary dysplasia diagnosisat 36 weeks corrected ageUsing the 2019 Jensen criteria: * Grade 1 - nasal cannula ≤2 L/min * Grade 2 - nasal cannula \>2 L/min or noninvasive positive airway pressure * Grade 3 - invasive mechanical ventilation

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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