a Multicentre, Double-blind, Randomized, Placebo-controlled Phase III Trial of the Inhaled β2-adrenergic Receptor Agonist Salbutamol for Transient Tachypnoea of the Newborn (the REFSAL Trial)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 608
- 试验地点
- 1
- 主要终点
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
研究概览
简要总结
Clinical trial evaluating the efficacy and safety of salbutamol for the treatment of neonates with a gestational age between 32 and 42 weeks with transient tachypnoea of the newborn (TTN).
详细描述
Multicentre, double-blind, phase III trial will include infants with a gestational age between 32 and 42 weeks and respiratory disorders treated in neonatal intensive care units in Poland. Infants will be enrolled no later than 24 h after birth and will be randomly assigned (1:1) to receive nebulized salbutamol with nCPAP or placebo (nebulized 0.9% NaCl) with nCPAP. The primary outcome is the percentage of infants with TTN who develop PPHN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth between 32 and 42 weeks.
- •Respiratory disorders (tachypnea and expiratory grunting) lasting longer than 15 minutes after birth, or present for at least 15 minutes in the first six hrs of life, or a need for non-invasive respiratory support between birth and six hrs of life.
- •Available chest radiographs obtained within six hrs after birth.
- •Available parameters of the acid-base balance (blood pH, partial pressure of O2 and CO2, base excess) and blood serum ionogram for Na+, K+, Ca2+ evaluated in the umbilical cord blood sample.
排除标准
- •Need for intubation directly after birth or perinatal asphyxia, defined as abnormal acid-base parameters detected in an umbilical cord blood sample (pH <7.0 or base excess < -14 mmol/L).
- •Multiple apnea-brady that require immediate intubation before a trial of NIV
- •Age >24 h.
- •Meconium aspiration syndrome.
- •Air leak syndrome.
- •Congenital heart disease.
- •Congenital diaphragmatic hernia.
- •Other severe congenital malformations and genetic disorders (diagnosed before and after birth) associated with increased risk of respiratory failure.
- •The need for a surfactant administration immediately after birth, regardless of the method of its administration (respiratory distress syndrome - RDS)
研究组 & 干预措施
CPAP+Salbutamol
All patients will receive nCPAP at 5-6 cm H2O pressure with an oxygen concentration of 21% or more to maintain preductal saturation between 90% and 95%. Patients assigned to the active group will be treated with 0.15 mg/kg body weight (diluted in 3 mL 0.9% NaCl) nebulised salbutamol (Ventolin®, GlaxoSmithKline, Dublin, Ireland) for 30 min.
干预措施: Salbutamol (Drug)
CPAP+Placebo
Patients in the placebo group will also receive nCPAP at 5-6 cm H2O pressure with an oxygen concentration of 21% or more to maintain preductal saturation between 90% and 95%. In addition, patients will receive 3 mL nebulised 0.9% NaCl administered for 30 min. as a placebo
干预措施: 0,9% Chloride Sodium (Drug)
结局指标
主要结局
Persistent Pulmonary Hypertension of the Newborn (PPHN)
时间窗: 7 days of life
PPHN defined as the need for ventilation with FiO2 \>0.30 and features of increased pulmonary pressure on echocardiogram
次要结局
- duration of ventilation(7 days of life)
- the severity of respiratory distress(48 hrs of life)
- need for intubation(7 days of life)
- duration of hospitalization(up to first month of life)