The Outcomes of Different Dexamethasone Regimens for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 970
- 试验地点
- 24
- 主要终点
- Incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age
研究概览
简要总结
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)
- 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.
- 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)
- 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.
详细描述
This study is a multicenter, prospective, randomized, parallel-controlled clinical trial.
Study Sites: Multiple hospitals across China with high-level Neonatal Intensive Care Units (NICUs) will participate.
Randomization:
A randomization method will be used to assign participants to one of two study groups in a 1:1 ratio. Subjects will receive a unique randomization number in the order of enrollment and will be assigned to one of the following treatment groups:
- DART regimen
- Moderate-dose tapering regimen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DART regimen
DART regimen group (cumulative dose 0.89 mg/kg over 10 days)
干预措施: Dexamethasone. Dart (Drug)
Medium-dose tapering regimen
Medium-dose tapering regimen group (cumulative dose 2.35 mg/kg over 7 days)
干预措施: Dexametasone. Medium (Drug)
结局指标
主要结局
Incidence of Bronchopulmonary dysplasia (BPD) and/or death at 36 weeks corrected age
时间窗: 36 weeks PMA
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).
次要结局
- 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))
- Total Length of Initial Hospitalization (Days from Birth to Discharge)(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age ))
- Incidence of Neonatal Complications Including ROP, IVH, Hemodynamically Significant PDA, Late-Onset Sepsis, PVL, NEC, SIP, Short Bowel Syndrome, and Pulmonary Hypertension(From birth until hospital discharge (up to approximately 44 weeks postmenstrual age))
- Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Cognitive Composite Score (MDI)(At 18 to 24 months corrected age)
- Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) - Motor Composite Score (PDI)(At 18 to 24 months corrected age)
- Griffiths Mental Development Scales - General Development Score(At 18 to 24 months corrected age)
研究者
Yanping Xu
Principal Investigator, Department of NICU
The Children's Hospital of Zhejiang University School of Medicine