Dexamethasone Regimens for BPD Prevention in Preterm Infants

NCT07052201 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2025-IRB-0185-P-02
• Study Type: interventional
• Target: 970
• Locations: 1 country
• Sites: 24

Brief 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. 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. 2.FiO₂ \> 40% and MAP \> 8 cmH₂O (maintained for at least 24 hours prior to enrollment).
3. 3.Parent/Legal guardian has provided signed informed consent.
4. 4.No use of other steroid medications prior to enrollment, as explicitly stated in the inclusion criteria.
5. 5.Presence of ventilator-associated pneumonia at the time of enrollment.
6. 6.Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.
7. 7.Suffering from other severe life-threatening illnesses with a short-expected survival time.
8. 8.Parent/Legal guardian refuses to participate in the study.

Conditions

Infant, Premature; Bronchopulmonary Dysplasia (BPD)

Outcome Measures

Primary Outcomes (1)

• Incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age

  Two different dexamethasone treatment regimens (DART regimen and moderate-dose tapering regimen) on the incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age in preterm infants meeting inclusion criteria BPD severity will be assessed at 36 weeks postmenstrual age (PMA) using the Jensen Criteria for BPD Severity, a categorical classification system. The Jensen Criteria define BPD severity based on the mode of respiratory support required at 36 weeks PMA: Grade 0: No BPD (no respiratory support) Grade 1: Nasal cannula ≤2 L/min Grade 2: Nasal cannula \>2 L/min or non-invasive positive airway pressure (e.g., continuous positive airway pressure (CPAP)), or noninvasive intermittent positive pressure ventilation (NIPPV) Grade 3: Invasive mechanical ventilation Higher grades represent worse outcomes (i.e., more severe BPD).

  36 weeks PMA

Secondary Outcomes (10)

• Extubation Rate (72 hours)

  72 hours

• Extubation Rate (7 days)

  7 days

• Incidence of Adverse Events Including Intestinal Perforation, Hyperglycemia, Hypertension, Infection, and Gastrointestinal Bleeding Following Dexamethasone Administration

  Within 72 hours and 7 days after dexamethasone administration

• Oxygenation index

  Baseline (Day 0) and on Days 3, 7, 10, 14, 28 Following Dexamethasone Therapy

• Total Duration of Invasive Mechanical Ventilation During Initial Hospitalization

  From birth until hospital discharge (up to approximately 44 weeks postmenstrual age)

Study Arms (2)

DART regimen

EXPERIMENTAL

DART regimen group (cumulative dose 0.89 mg/kg over 10 days)

Drug: Dexamethasone. Dart

Medium-dose tapering regimen

EXPERIMENTAL

Medium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days)

Drug: Dexametasone. Medium

Interventions

Dexamethasone. Dart DRUG

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.

DART regimen

Dexametasone. Medium DRUG

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.

Medium-dose tapering regimen

Eligibility Criteria

• Age: 14 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• FiO₂ \> 40% and MAP \> 8 cmH₂O (maintained for at least 24 hours prior to enrollment).
• Parent/Legal guardian has provided signed informed consent.

You may not qualify if:

• Presence of ventilator-associated pneumonia at the time of enrollment.
• Severe congenital malformations (e.g., severe cardiac anomalies, congenital diaphragmatic hernia, etc.), or known immunodeficiency.
• Suffering from other severe life-threatening illnesses with a short-expected survival time.
• Parent/Legal guardian refuses to participate in the study.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (24)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 0571, China

Location

Chengdu Maternal and Children's Health Care Hospital

Chengdu, China

Location

Children's Hospital of Chongqing Medical University

Chongqing, China

Location

Women and Children's Hospital of Chongqing Medical University

Chongqing, China

Location

Guangdong Women and Children Hospital

Guangdong, China

Location

Guangxi Maternal and Child Health Hospital

Guangxi, China

Location

Guiyang Maternity and Child Health Care Hospital

Guiyang, China

Location

Guizhou Provincial People's Hospital

Guizhou, China

Location

The First Hospital of Jilin University

Jilin, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, China

Location

Jiangxi Maternal and Child Health Hospital

Nanchang, China

Location

Nanjing Maternity and Child Health Care Hospital

Nanjing, China

Location

Ningbo Women & Children's Hospital

Ningbo, China

Location

QuanZhou Women and Children's Hospital

Quanzhou, China

Location

Qujing Maternal and Child Health Hospital

Qujing, China

Location

Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Shengjing Hospital

Shengyang, China

Location

Shenzhen Maternal and Child Health Hospital

Shenzhen, China

Location

Fourth Hospital of Shijiazhuang City

Shijiazhuang, China

Location

Xiamen Women's and Children's Hospital

Xiamen, China

Location

First Affiliated Hospital of Xinjiang Medical University

Xinjiang, China

Location

Zhangzhou Affiliated Hospital of Fujian Medical University

Zhangzhou, China

Location

Zhengzhou Children's Hospital, China

Zhengzhou, China

Location

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Zheng Chen

CONTACT

8613857151000; chenz@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of NICU

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 4, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (24)