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Dexamethasone Regimens for BPD Prevention in Preterm Infants

StatusNot Yet Recruiting
PhasePhase 3
Started2026-02-01
View on ClinicalTrials.gov ↗

Amendment history

2025-11-19
minor
Study Status, Study Description, Outcome Measures v3
Primary endpoints1 entry, revised
Incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age
Study description+2,755 characters
This study is a multicenter, prospective, randomized, parallel-controlled clinical trial. Study Sites: Multiple hospitals across China with high-level Neonatal Intensive Care Units (NICUs) will participate. Randomization: A randomization method will be used to assign participants to one of two study [...]
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
2025-06-26
minor
Original filing
The goal of this clinical trial is to compare the effectiveness of two different dexamethasone treatment regimens (the DART regimen and the medium-dose tapering regimen) in reducing the incidence of Bronchopulmonary Dysplasia (BPD) or death by 36 weeks of postmenstrual age in premature infants. This study will also assess the safety of these treatments. The main questions it aims to answer are: Does the DART regimen, compared to the medium-dose tapering regimen, lower the rate of BPD or BPD-related death by 36 weeks of postmenstrual age in eligible premature infants? How do the two regimens compare in terms of short-term respiratory outcomes (like time to come off the ventilator), complications at hospital discharge, and long-term neurodevelopmental outcomes at 18-24 months of corrected age? Researchers will compare the DART regimen group (lower cumulative dose, given over 10 days) to the medium-dose tapering regimen group (higher cumulative dose, given over 7 days) to see which one is more effective and safer. Participants will: Inclusion Criteria (Must meet ALL of the following) 1. Gestational age 24+0 to 29+6 weeks; requires invasive mechanical ventilation for ≥14 days after birth; within 14-28 days of age at first receive of dexamethasone. 2. FiO₂ \> 40% and MAP \> 8 cmH₂O (maintained for at least 24 hours prior to enrollment). 3. Parent/Legal guardian has provided signed informed consent. 4. No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria. 2\. Exclusion Criteria (Will be excluded if they meet ANY of the following) 1. Presence of ventilator-associated pneumonia at the time of enrollment. 2. Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency. 3. Suffering from other severe life-threatening illnesses with a short-expected survival time. 4. Parent/Legal guardian refuses to participate in the study.
Trial Details
NCT Number NCT07052201
Lead Sponsor The Children's Hospital of Zhejiang University School of Medicine
Collaborators: Children's Hospital of Chongqing Medical University
Conditions Infant, Premature, Bronchopulmonary Dysplasia (BPD)
Enrollment 970 participants
Start Date 2026-02-01
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-24