Dexamethasone Regimens for BPD Prevention in Preterm Infants

Summary

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.

Conditions

• Infant, Premature
• Bronchopulmonary Dysplasia (BPD)

Interventions

DRUG

Dexamethasone. Dart

DART regimen group (cumulative dose 0.89 mg/kg over 10 days): intravenous dexamethasone administered as follows: 0.075 mg/kg/dose every 12 hours for 3 days 0.05 mg/kg/dose every 12 hours for 3 days 0.025 mg/kg/dose every 12 hours for 2 days 0.01 mg/kg/dose every 12 hours for 2 days, then discontinue. If extubation is not successful more than or equal to 2 weeks after completing the treatment, the regimen may be repeated.

DRUG

Dexametasone. Medium

Medium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days): intravenous dexamethasone administered as follows: 0.5 mg/kg/d for 3 days 0.25 mg/kg/d for 3 days 0.1 mg/kg/d for 1 day If extubation is not successful more than or equal to 2 weeks after completing the treatment, the regimen may be repeated.

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• The Children's Hospital of Zhejiang University School of Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Days

Max Age

28 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-01-31

Completion

2028-05-31

Countries

• China

Study Locations