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Dexamethasone Regimens for BPD Prevention in Preterm Infants
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
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.
Official title: The Outcomes of Different Dexamethasone Regimens for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
14 Days - 28 Days
Study Type
INTERVENTIONAL
Enrollment
970
Start Date
2026-02-01
Completion Date
2028-05-31
Last Updated
2025-11-24
Healthy Volunteers
No
Interventions
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.
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.
Locations (24)
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Chengdu Maternal and Children's Health Care Hospital
Chengdu, China
Children's Hospital of Chongqing Medical University
Chongqing, China
Women and Children's Hospital of Chongqing Medical University
Chongqing, China
Guangdong Women and Children Hospital
Guangdong, China
Guangxi Maternal and Child Health Hospital
Guangxi, China
Guiyang Maternity and Child Health Care Hospital
Guiyang, China
Guizhou Provincial People's Hospital
Guizhou, China
The First Hospital of Jilin University
Jilin, China
First Affiliated Hospital of Kunming Medical University
Kunming, China
Jiangxi Maternal and Child Health Hospital
Nanchang, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, China
Ningbo Women & Children's Hospital
Ningbo, China
QuanZhou Women and Children's Hospital
Quanzhou, China
Qujing Maternal and Child Health Hospital
Qujing, China
Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shengjing Hospital
Shengyang, China
Shenzhen Maternal and Child Health Hospital
Shenzhen, China
Fourth Hospital of Shijiazhuang City
Shijiazhuang, China
Xiamen Women's and Children's Hospital
Xiamen, China
First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, China
Zhengzhou Children's Hospital, China
Zhengzhou, China