2025-11-15
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Document Section v2
Start date2025-07-01→2026-02-01
Enrollment target1212→970
Study sites22→24
Study arms3→2
InterventionsDexametasone (Drug), Dexamethasone (Drug), Dexamethasone (Drug)→Dexametasone. Medium (Drug), Dexamethasone. Dart (Drug)
Eligibility criteria+83 characters
Inclusion Criteria: (Must meet ALL of the following)
Gestational age between24+0 24to 29+6 weeks; 0 days and 29 weeks 6 days
Requiresrequires invasive mechanical ventilation for ≥814 days postnatally
Firstafter dosebirth; ofwithin study medication administered between 8 and 14-28 days of lifeage at first receive of dexamethasone.
FiO₂ > 40% and Mean Airway Pressure (MAP) > 8 cmH₂O, (maintained for at least 24 hours prior to enrollment).
SignedParent/Legal guardian has provided signed informed consent form from parent(s) or legal guardian(s).
No prior use of systemicother steroid medications be [...] [...]
Secondary endpoints9 to 10 entries
IncidenceExtubation and Severity of Bronchopulmonary DysplasiaRate (BPD72 hours)
Extubation at 36 Weeks Postmenstrual AgeRate (PMA7 days), Classified Using the Jensen Criteria
Primary endpoints2 to 1 entries
ExtubationIncidence Rateof (7BPD days)
Extubationand/or Ratedeath (72at hours)36 weeks corrected age
2025-07-04
minor
Study Status, Sponsor/Collaborators, Outcome Measures, Document Section v1
Secondary endpointsdetails revised at 2 of 9 entries