Single Dose Antenatal Corticosteroids (SNACS) Pilot Randomized Control Trial for Women at Risk of Preterm Birth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of the study protocol
研究概览
简要总结
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome, in preterm infants.
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity.
We plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (total 12 mg) of betamethasone to the standard double dose (total 24 mg) of betamethasone.
The results of this pilot will be combined with the full-scale RCT (NCT05114096) for which we have received funding from the Canadian Institutes of Health Research (CIHR).
详细描述
Preterm infants are at risk of mortality and morbidity. Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome.
Standard of care for women at risk of preterm birth includes 2 doses of 12 mg betamethasone (for a total of 24 mg) to accelerate fetal lung maturity. There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses.
Pilot trials are now viewed as an "almost essential prerequisite" to large, expensive, full scale studies. Thus, we plan to conduct a pilot clinical trial to determine the feasibility of a trial comparing half the usual dose (12 mg of betamethasone + placebo) to the standard double dose (12 mg + 12 mg of betamethasone), as well as the feasibility of the study protocol. Secondary outcomes will include process outcomes and pilot clinical outcomes, that will be combined with the full-scale RCT for which we have received funding from CIHR.
We plan to conduct a 24-month corrected gestational age follow-up, which will consist principally of 2 validated parent-filled questionnaires:
- Ages and Stages Questionnaire-3 (ASQ)
- Child Behavior Checklist
- A single question parent report of whether there has been a physician diagnosis of cerebral palsy. (recommended by our parent partners)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at risk of preterm birth with a singleton or twins between =>22+0/7 and <=34+6/7 weeks' gestation
- •Pregnant with either singletons or twins
- •Has already received the first dose of 12 mg intramuscular betamethasone within the past 24 hours
- •All fetuses are alive and without compromise as per ultrasound or fetal heart monitor
- •Is capable of giving informed, written consent in English
排除标准
- •Any contraindications to receiving corticosteroids
- •Requires chronic doses of corticosteroids secondary to a medical condition (e.g. systemic lupus erythematosus, severe asthma, congenital adrenal hyperplasia, etc.)
- •Received any prior doses of antenatal corticosteroids except for the 1st dose of 12 mg intramuscular betamethasone
- •Had any previous participation in this trial
- •Pregnant with a fetus with severe congenital anomaly (e.g. anencephaly, transposition of the great arteries, etc.) or major chromosomal abnormalities (e.g. Trisomy 18, Trisomy 21, etc.)
- •Pregnant with monoamniotic/monochorionic (Mono/Mono) twins
研究组 & 干预措施
Single-Dose (12 mg betamethasone + placebo)
The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed.
Participants randomized to the experimental "Single-Dose" arm will receive a similar appearing placebo injection instead of the standard 2nd dose of 12 mg of betamethasone (i.e. they will receive the experimental single-dose regimen, total 12 mg of betamethasone only from the first injection).
干预措施: 12 mg betamethasone + placebo (Drug)
Double-Dose (12 mg betamethasone + 12 mg betamethasone)
The standard course of betamethasone consists of 2 intramuscular injections of 12 mg betamethasone 24 hours apart for a total dose of 24 mg. Before enrolment and randomization in the SNACS trial, all women will have received a first 12 mg injection of betamethasone according to local hospital protocols. After this first injection, randomization is performed.
Participants randomized to the "Double-Dose" arm will receive the standard 2nd dose of 12 mg of betamethasone injected intramuscularly (i.e. they will receive the standard double-dose regimen, total 24 mg of betamethasone).
干预措施: 24 mg betamethasone (Drug)
结局指标
主要结局
Feasibility of the study protocol
时间窗: 5-6 months
Feasibility of the study intervention will be defined as =\> 98% compliance with the protocol
Feasibility of conducting a full-scale trial
时间窗: 5-6 months
Feasibility of conducting a full-scale trial will be defined as =\> 50% recruitment of approached participants
次要结局
- Severe intraventricular haemorrhage rates(5-6 months)
- Neonatal mortality rates(5-6 months)
- Process outcomes(5-6 months)
- Duration of mechanical ventilation requiring an endotracheal tube(5-6 months)
- Anthropometry composite (<10% of expected weight, length, or head circumference for birth week)(5-6 months)
- 24-month follow-up(18-30 months)
- Respiratory morbidity rates(5-6 months)
- Duration of ventilatory support not requiring an endotracheal tube(5-6 months)
- Length of stay in neonatal intensive care unit(5-6 months)
- Rates of severe bowel problems due to necrotizing enterocolitis(5-6 months)
- Late respiratory morbidity (i.e. bronchopulmonary dysplasia) rates(5-6 months)
- Severe late brain injury (periventricular leukomalacia) rates(5-6 months)
- Intrauterine fetal demise rates(5-6 months)
- Rates of hypotension < 48 hours of life requiring treatment with hydrocortisone or inotropic medications(5-6 months)
- Need for supplemental oxygen and duration(5-6 months)
- Early neonatal sepsis rates(5-6 months)
- Number of infants with retinopathy of prematurity needing treatment(5-6 months)
- Patent ductus arteriosus needing a closure procedure(5-6 months)
研究者
Sarah McDonald
Principal Investigator
McMaster University