Randomized Controlled Trial of Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- The primary outcome to be studied is the need for NICU admission and/or oxygen therapy or PPV for >30 minutes.
研究概览
简要总结
This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (>34 and <40 weeks of gestation) who are scheduled to undergo a planned Cesarean section. The study design is to determine the efficacy and safety of betamethasone in the prevention of breathing problems commonly seen in this population.
In infants born by elective Cesarean section, it is hypothesized that antenatal betamethasone treatment will reduce the risk of neonatal intensive care unit (NICU) admission from 11% to 8% and/or oxygen therapy +/- positive pressure ventilation (PPV) for >30 minutes from 4.5% to 2.5%.
详细描述
The purpose of this pilot study is to determine if antepartum betamethasone given to mothers undergoing elective cesarean section (ECS) delivery at term or near term gestation (>34 and < 40 weeks of gestation) is safe and feasible in reducing neonatal respiratory morbidity and the related admissions to neonatal intensive care units (NICU).
The data from this pilot study will be used to support a NIH application for a multicenter randomized trial to determine, if compared to placebo treatment, antenatal betamethasone initiated 2-7 days prior to an ECS results in decreased occurrence of respiratory morbidity and NICU admissions in the newborn.
The multicenter protocol was recently reviewed by the NICHD network for clinical trial. The reviewers were enthusiastic about the scientific merit and public health importance of the study but asked for a pilot study to determine feasibility before launching the national trial. Given the rise in the rate of CS deliveries, we project substantial health cost savings from this preventive strategy if it were found to be successful in reducing neonatal morbidity.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women >/= 34 weeks gestation scheduled to undergo operative delivery within 48-72 hours after study enrollment
排除标准
- •Known contraindication to the use of betamethasone in the mother
- •Known lethal or non-lethal congenital anomaly diagnosed antenatally
- •Spontaneous labor
- •Premature rupture of membranes
研究组 & 干预措施
Betamethasone
Betamethasone injection
干预措施: Betamethasone (Drug)
Placebo
Placebo injection
干预措施: Betamethasone (Drug)
结局指标
主要结局
The primary outcome to be studied is the need for NICU admission and/or oxygen therapy or PPV for >30 minutes.
时间窗: 24 hours
Respiratory distress in the first 24 hours after birth.
次要结局
未报告次要终点
研究者
Lucky Jain
Principal Investigator
Emory University