Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome.
试验速览
- 阶段
- 4 期
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Bronchopulmonary dysplasia or death
研究概览
简要总结
This study evaluates the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome. Half of the participants will receive budesonide and poractant alfa in combination, and the other half will receive poractant alfa with saline.
详细描述
A randomized double bind controlled trial, designed to evaluate the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia (BPD) in preterm infants with respiratory distress syndrome (RDS).
The usual treatment of RDS includes ventilatory support and exogenous surfactant, however, a cronic lung disease known as BPD, is a complication found in many of these patients.
BPD is a complex disease occurring in preterm infants recovering from RDS and inflammation plays a key role in its physiopathology.
Animal derived surfactants have demonstrated to decrease the incidence of BPD, and porcine surfactant (poractant alfa) has and increased effect compared with bovine surfactant (beractant).
Budesonide is an inhaled anti-inflammatory steroid that has shown to reduce BPD when combined with beractant by decreasing lung inflammation, without secondary systemic effects, when combined with poractant alfa it could enhance even more this anti-inflammatory effect.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 12 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight <1500g
- •Gestational age ≥ 26 weeks
- •Respiratory distress syndrome that requires exogenous surfactant at birth or in the first 12 hours of life.
排除标准
- •Major congenital anomalies.
- •Perinatal asphyxia
- •Respiratory depression secondary to general anesthesia.
研究组 & 干预措施
Poractant alfa/budesonide
A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal
干预措施: Budesonide (Drug)
Poractant alfa/budesonide
A mixture of poractant (200mg/kg) and budesonide (0.25 mg/kg) will be instilled intratracheal
干预措施: Poractant Alfa (Drug)
Poractant alfa/saline
A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal
干预措施: Poractant Alfa (Drug)
Poractant alfa/saline
A mixture of poractant (200mg/kg) and saline (1 ml/kg) will be instilled intratracheal
干预措施: Saline (Drug)
结局指标
主要结局
Bronchopulmonary dysplasia or death
时间窗: Oxygen requirement at 36 weeks post menstrual age in patients <32 weeks. Oxygen requirement between 29 to 55 days of age in patients >32 weeks
Diagnosis of bronchopulmonary dysplasia according to NICHD criteria
次要结局
未报告次要终点
研究者
Raúl Héctor Roque Sánchez
MD
Hospital Central "Dr. Ignacio Morones Prieto"