Evaluating the Efficacy and Safety of an Innovative and Affordable Goat Lung Surfactant for the Treatment of Respiratory Distress Syndrome in Preterm Neonates: a Multi-site Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 900
- 主要终点
- BPD free survival
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of Cadisurf (goat lung surfactant extract) as compared to Survanta (beractant) in the treatment of respiratory distress syndrome in preterm neonates (with gestation of 26 to 32 weeks).
详细描述
Title: Evaluating the Efficacy and Safety of an Innovative and Affordable Lung Surfactant for the treatment of Respiratory Distress Syndrome (RDS) in preterm neonates: a multi-site randomized clinical trial
Phase of Development: Phase II/ III
Indication: Respiratory Distress Syndrome
Primary Objective: To compare the incidence of survival without bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age in preterm neonates (≤32 wk) with RDS randomized to receive intratracheal administration (100 mg/kg) of either goat lung surfactant extract (GLSE) or the standard preparation (Beractant; Survanta; Abbott, USA)
Secondary Objective: 1 To compare area under curve (AUC) for oxygen requirement (FiO2) requirement in first 48 h of surfactant administration
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
- 26 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates born at the study sites and fulfilling all of the following criteria will be eligible for enrolment in the study
- •Gestational age ≤32 completed weeks
- •Onset of respiratory distress within six hours of age
- •If baby meets criteria for surfactant replacement therapy:
- •FiO2 needed is 40% or higher while the baby is on CPAP to maintain pre-ductal oxygen saturation between 90% to 95% or
- •Baby needs intubation because of CPAP failure or severe respiratory distress (Chest X-ray is not mandatory for deciding the need for SRT). Detailed SOPs will be developed with respect to assessing the eligibility for SRT
排除标准
- •Neonates with any of the following criteria will be excluded:
- •Gestation below 26 wk
- •Babies with severe birth asphyxia as defined by the need for chest compressions and/or initial (umbilical arterial/or within 1 hour of birth) pH <7.0
- •Major congenital malformations
- •Prophylactic surfactant administration, i.e. administration of surfactant before the infant develops respiratory distress
- •Air leak or pulmonary hemorrhage prior to enrollment
- •Shock requiring vasopressor support prior to enrollment
研究组 & 干预措施
Cadisurf (goat lung surfactant extract)
Neonates in the intervention group will be intratracheally administered 100 mg/kg of GLSE (CADISURF®).
干预措施: Cadisurf (Drug)
Survanta (Beractant)
干预措施: Survanta (Drug)
结局指标
主要结局
BPD free survival
时间窗: 36 weeks post menstrual age
Survival free from BPD defined as per the definition provided by NIH
次要结局
- IVH grade 3 or 4(72±24 hrs)
- Area under the curve for (AUC) for oxygen requirement (FiO2) requirement in first 48 h(48 hours after surfactant replacement therapy)
- Any air leak within 72 hours of administration of surfactant(72 hours after surfactant replacement therapy)
- Retinopathy of prematurity (ROP)(Eyes of the babies would be examined by the ophthalmologists starting from 4 wk of life)
- Neonatal Mortality(first 28 days of life)
- PVL-cystic and non-cystic(28±7days)
- Pulmonary haemorrhage(48 hours after surfactant replacement therapy)
- Respiratory support at 7 days of age(7 days of age)
- Respiratory support at 72 h(72 hours of age)
- Duration of mechanical ventilation and CPAP(36 weeks postmenstrual age)
- Duration of hospital stay(36 weeks postmenstrual age)
- Periventricular Leukomalacia (PVL)-cystic and non-cystic(72±24 hrs)
- Sepsis(7 days of age)
研究者
Ramesh K Agarwal
Additional Professor
All India Institute of Medical Sciences, New Delhi