Dexamethasone Regimens for BPD Prevention in Preterm Infants

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,212

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

May 31, 2028

Conditions
Infant, PrematureBronchopulmonary Dysplasia (BPD)
Interventions
DRUG

Dexamethasone

"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 within one week after completing the treatment, the regimen may be repeated."

DRUG

Dexamethasone

"Low-dose tapering regimen group (cumulative dose 0.45 mg/kg over 3 days): intravenous dexamethasone administered as follows:~0.1 mg/kg/dose every 12 hours on Day 1 0.075 mg/kg/dose every 12 hours on Day 2 0.05 mg/kg/dose every 12 hours on Day 3 If extubation is not successful within one week after completing the treatment, the regimen may be repeated."

DRUG

Dexametasone

"Medium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days): intravenous dexamethasone administered as follows:~0.5 mg/kg/dose once daily for 3 days 0.25 mg/kg/dose once daily for 3 days 0.1 mg/kg/dose once daily for 1 day If extubation is not successful within one week after completing the treatment, the regimen may be repeated."

Trial Locations (22)

0571

Children's Hospital, Zhejiang University School of Medicine, Hangzhou

Unknown

Chengdu Maternal and Children's Health Care Hospital, Chengdu

Children's Hospital of Chongqing Medical University, Chongqing

Guangdong Women and Children Hospital, Guangdong

Guangxi Maternal and Child Health Hospital, Guangxi

Guiyang Maternity and Child Health Care Hospital, Guiyang

Guizhou Provincial People's Hospital, Guizhou

The First Hospital of Jilin University, Jilin

First Affiliated Hospital of Kunming Medical University, Kunming

Jiangxi Maternal and Child Health Hospital, Nanchang

Nanjing Maternity and Child Health Care Hospital, Nanjing

Ningbo Women & Children's Hospital, Ningbo

QuanZhou Women and Children's Hospital, Quanzhou

Qujing Maternal and Child Health Hospital, Qujing

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai

Shengjing Hospital, Shengyang

Shenzhen Maternal and Child Health Hospital, Shenzhen

Fourth Hospital of Shijiazhuang City, Shijiazhuang

Xiamen Women's and Children's Hospital, Xiamen

First Affiliated Hospital of Xinjiang Medical University, Xinjiang

Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou

Zhengzhou Children's Hospital, China, Zhengzhou

All Listed Sponsors
collaborator

Children's Hospital of Chongqing Medical University

OTHER

lead

The Children's Hospital of Zhejiang University School of Medicine

OTHER