An open-label randomized controlled trial to compare the time to reach full enteral feeds between the use of prophylactic Glycerin enema and Glycerin suppository and standard of care in neonates less than 1500 grams at birth
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day
研究概览
简要总结
Enteral nutrition optimization in Very Low Birthweight neonates is challenging due to feed intolerance. Delayed meconium passage is more common in more premature infants, leading to obstructed deep intestinal segments and a delay in achieving full feeds.Glycerin laxatives stimulate passage of meconium by acting as an osmotic dehydrating agent and increasing osmotic pressure in the gut; they stimulate rectal contraction, potentially reducing the incidence of feeding intolerance.The Glycerin laxatives are among the commonly used strategies in preterm infants to treat or prevent feeding intolerance and to facilitate normal stooling pattern. However the evidence on the use of Glycerin laxatives in promoting feeding tolerance is limited. In this study, we aim to do a three-arm randomized controlled trial to compare the efficacy of Glycerin enema versus Glycerin suppository versus standard of care in reducing the time to reach full enteral feeds in neonates less than 1500 grams at birth. We hypothesize that there would be no difference in time to reach full enteral feeds in either of the study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •neonates admitted to neonatal intensive care unit (NICU) on day-1 of life with birthweight less than 1500 grams at birth.
排除标准
- •Congenital anomalies 2)Major surgery within 48 h of birth.
- •Neonate with APGAR less than 7 at 5 minutes of life.
- •Hemodynamically unstable neonate- e.g those requiring inotrope support.
结局指标
主要结局
The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day
时间窗: The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day | for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with | standard of care in neonates less than 1500 grams at birth.
for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with
时间窗: The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day | for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with | standard of care in neonates less than 1500 grams at birth.
standard of care in neonates less than 1500 grams at birth.
时间窗: The time (in days) required to achieve full enteral feeds (enteral feed volume of 150 ml/kg/day | for atleast 24 hours) between the use of prophylactic glycerin enema, glycerin suppository with | standard of care in neonates less than 1500 grams at birth.
次要结局
- 1)To compare time required to regain birth weight between the use of prophylactic glycerin(enema, glycerin suppository with standard of care in neonates less than 1500 grams at)
研究者
Prasoon Bansal
Bharati Vidyapeeth Deemed University Medical College, Pune