To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Day of life to reach full feeds
研究概览
简要总结
To evaluate the duration to reach full feeds by comparing continuous gavage feeds versus bolus feeds in preterm infants who are on non-invasive respiratory support (RAM cannula - short binasal prongs).
详细描述
Methods:
The study will be a randomized control trial at our NICU (Neonatal Intensive Care Unit) (Level III). Preterm infants on non -invasive ventilation (nasal intermittent positive pressure ventilation (NIPPV)/ continuous positive airway pressure (CPAP)) will be randomly assigned into either continuous feeds or bolus feeds groups. Baby will be fed enterally through a nasogastric tube via continuous or bolus feeds using either maternal milk or formula, according to parental choice. Feeds will be advanced as per the feeding guidelines or per treating physician. Currently we use both bolus and continuous feeding practice in our NICU, as per physician's discretion.
Intervention:
Infants will be randomized into 2 groups; one will receive continuous nasogastric feeding and the other group will receive intermittent bolus feeds. Continuous feeds will be delivered via an indwelling nasogastric/orogastric tube with a continuous infusion pump. Intermittent bolus feedings will be given by gravity every 3 hours over 15- 30 minutes.
Parents' consent will be taken when the infant is qualified for the study. The consent will be taken by one of the coinvestigators. Each coinvestigator will be trained to consent for standardization. Non-English-speaking parents will be consented using the medical video interpreter (Voyce). Accent will not be obtained as neonates aren't mature to give accent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Caregivers, study personnel and nurses will not be blinded, as blinding will be hard for the treating team. Parents will not be blinded as we inform about the infant's progress and plan routinely. Statisticians will be blinded during (they will receive de-identified data).
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm Infants 24- 34 weeks of gestation
- •On Non-invasive ventilation (NIPPV/CPAP/HFNC)
- •Nothing by mouth (NPO) or on trophic feeds (<20 ml/kg/day) at the time of randomization.
排除标准
- •Gestational Age > 34 weeks
- •Infants on invasive ventilation or low flow nasal cannula and on feeding volume more than trophic feeds.
- •Major congenital anomalies.
结局指标
主要结局
Day of life to reach full feeds
时间窗: From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.
the day of life to reach full feed, that is, 120 ml/kg/day.
次要结局
- Feeding interruptions(From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.)
- Use of investigative medicine for feeding intolerance(From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.)
- Time to reach (day of life) first oral feed(From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.)
- Weight gain, head circumference (HC) and Length.(From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.)
- Length of hospital stay(From the date of randomization until the date of NICU discharge/death, assessed up to 1 year.)
研究者
Rajeev Kumar
Principal Investigator
Cook County Health