Efficacy and Safety of Glycerin Suppositories for Treatment of Feeding Intolerance in Very Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Time to full feeding (days)
研究概览
简要总结
Feeding intolerance is a common problem in preterm infants.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with birth weight equal or less than 1500 g
排除标准
- •Significant congenital malformations
- •Severity of illness such that death is likely in the first few days after birth
研究组 & 干预措施
Glycerin group (GG)
Glycerin group "GG" will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery.
干预措施: Glycerin (Drug)
Rectal stimulation group (SG)
Rectal stimulation "SG" by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall.
干预措施: Rectal stimulation (Procedure)
Control group (CG)
Control group "CG" will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes.
干预措施: Control (Other)
结局指标
主要结局
Time to full feeding (days)
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Days to achieve full enteral feeding
次要结局
- Length of hospital stay (days)(At discharge from hospital, an expected average of 8 weeks)
- Incidence of feeding intolerance(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Incidence of proven late onset infection(Participants will be followed for the duration of hospital stay, an expected average of 8 weeks)
- Incidence of necrotizing enterocolitis (NEC)(Participants will be followed for the duration of hospital stay, an expected average of 8 weeks)
- Incidence of hyperbilirubinemia(Participants will be followed for the duration of hospital stay, an expected average of 8 weeks)