Efficacy Of Intratracheal Administration Of Budesonide To Prevent Bronchopulmonary Dysplasia In Neonate With Gestational Age Less Than 32 Weeks/Birth Weight Less Than 1500 Grams With Respiratory Distress Syndrome Who Received Surfactant
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Bronchopulmonary dysplasia
研究概览
简要总结
The goal of this clinical trial is to learn if budesonide works to prevent bronchopulmonary dysplasia in newborn less than 32 weeks gestational age or birth weight less than 1500 g with respiratory distress syndrome who needs surfactants. Does budesonide lower the incidence of bronchopulmonary dysplasia? What medical problems do participants have after given budesonide? Researchers will compare intratracheal budesonide and surfactant to intratracheal surfactant only to see if budesonide works to prevent bronchopumonary dysplasia.
Participants will:
Given intratracheal budesonide and surfactant and followed up until 36 weeks of post menstrual age to determine whether they have bronchopulmonary dysplasia or not
详细描述
Subject is all neonates born with gestational age less than 32 weeks or birth weight under 1500 g with respiratory distress syndrome and need surfactant was randomized into two groups: intervention and control Intervention group will received budesonide (pulmicort) 0.25 mg/kgBB diluted with beractant (survanta) 100 mg/kgBB intratracheal, the solution is divided into 3 aliquotes Control group will received beractant (survanta) 100 mg/kgBB intratracheal divided into 3 aliquotes All subjects will be followed up until 36 weeks post menstruational age do define whether the developed bronchopulmonary dysplasia or not
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
- Double (Investigator, Outcomes Assessor)
盲法说明
This was a single-blind study. The intervention team was aware of the treatment allocation owing to preparation requirements, whereas the attending pediatricians and clinical staff responsible for patient management and outcome assessment were blinded to the group assignment.
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birth weight less than 1500 g
- •gestational age less than 32 weeks
- •less than 48 hours of age
- •diagnosed as respiratory distress syndrome and need surfactant
- •get parental consent
排除标准
- •- chromosom abnormality
- •critical congenital heart disease
- •congenital pulmonal disease
- •Need surgery within 1 month
- •mother with chorioamnionitis
- •received postnatal corticosteroid before
结局指标
主要结局
Bronchopulmonary dysplasia
时间窗: subject collection: 8 months, data processing 1 month, publication 1 month
The primary outcome was the incidence of BPD of any severity at 36 weeks' postmenstrual age in infants born at \<32 weeks' gestation or weighing \<1500 g.
次要结局
未报告次要终点
研究者
Adhi Teguh Perma Iskandar, Sp
Clinical Investigator
Indonesia University