Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia: A Study in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 511
- 试验地点
- 21
- 主要终点
- Survival Without BPD at 36 Weeks Post Menstrual Age.
研究概览
简要总结
The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated infants.
详细描述
This is a multi-center, blinded, randomized controlled clinical trial to evaluate the effects of booster doses of exogenous surfactant (Infasurf®, calfactant) in addition to inhaled nitric oxide (iNO) on the outcome of survival without bronchopulmonary dysplasia (BPD, or chronic lung disease of prematurity, characterized by chronic lung dysfunction) at 36 weeks' post-menstrual age (PMA) in extremely low gestational age (ELGAN) infants that are at high risk of the development of BPD. This multi-center trial, with a planned enrollment of 524 infants, will also enable us to evaluate for any adverse effects of late surfactant treatment on short- and long-term outcomes, as we will be collecting data on effects of dosing of late surfactant, co-morbidities of prematurity and neurodevelopmental and pulmonary outcome at 1 year and 24 months corrected age. In addition, we will collect biological specimens for evaluation of the effects of late surfactant replacement therapy (administered as described in this trial) on surfactant function and inflammatory markers.
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
- 年龄范围
- 7 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<=28 0/7 weeks gestational age
- •Day of life 7-14
- •Intubated and mechanically ventilated
- •Plan to treat with inhaled nitric oxide
排除标准
- •Serious congenital malformations or chromosomal abnormalities
- •Life expectancy <7 days from enrollment
- •Clinically unstable
- •Less tha 48 hours since last dose surfactant
- •Ability to obtain 36 week primary outcome information is unlikely
研究组 & 干预措施
Infasurf surfactant (ONY, Inc.)
Infants already receiving inhaled nitric oxide will receive scheduled doses of late surfactant (Infasurf) on study days 0, 2, 4, 6 and 8.
干预措施: Infasurf surfactant (ONY, Inc.) (Drug)
Sham (No Treatment)
Infants already receiving inhaled nitric oxide will receive "Sham (no treatment)" doses on study days 0,2,4,6, and 8.
干预措施: Sham (No Treatment) (Drug)
结局指标
主要结局
Survival Without BPD at 36 Weeks Post Menstrual Age.
时间窗: 36 weeks post menstrual age +/- 1 week
BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction.
次要结局
- Respiratory Outcomes of TOLSURF Infants at 1 Year Corrected Age(1 year)
- Pulmonary Outcomes Through 2 Years of Age(2 years)
- Percentage of Participants With Neurodevelopmental Impairment (NDI) at 2 Years.(2 years)
- Survival Without BPD at 40 Weeks(40 weeks PMA +/- 1 week)
研究者
Roberta Ballard
Professor of Pediatrics
University of California, San Francisco