Dexamethasone Regimens for BPD Prevention in Preterm Infants
Status:
NOT_YET_RECRUITING
Trial end date:
2028-05-31
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to compare the effectiveness and safety of three different dexamethasone treatment regimens (DART regimen, low-dose tapering regimen, and medium-dose tapering regimen) in improving extubation success rates in preterm infants who require prolonged invasive mechanical ventilation. The main questions it aims to answer are:
What is the extubation success rate (defined as no reintubation within 72 hours and 7 days) after the first course of treatment in each group? How do the three regimens differ in terms of safety, including the incidence of short-term and long-term complications? Researchers will compare the DART regimen, low-dose tapering regimen, and medium-dose tapering regimen to see if any regimen leads to higher extubation success rates and fewer adverse outcomes.
Participants will:
Be randomized 1:1:1 to receive one of the three dexamethasone regimens via intravenous injection.
Receive standard respiratory and medical management in addition to the study drug.
Undergo regular assessments of oxygenation index (OI) at days 0, 3, 7, 10, 14, and 28 of treatment.
Be monitored for adverse events such as gastrointestinal bleeding, hyperglycemia, and hypertension.
Be followed until hospital discharge for outcomes including BPD severity, complications (e.g., ROP, IVH, NEC), and total duration of ventilation and hospitalization.
Undergo neurodevelopmental follow-up at 18-24 months corrected age using Bayley-III or Griffiths developmental scales.
Participants are preterm infants born between 24 and 29+6 weeks of gestation who require invasive ventilation for at least 8 days and meet strict oxygen and pressure criteria before enrollment. Infants with major congenital anomalies, immunodeficiencies, or life-threatening conditions will be excluded.
Phase:
PHASE3
Details
Lead Sponsor:
The Children's Hospital of Zhejiang University School of Medicine
Collaborator:
Children's Hospital of Chongqing Medical University