Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Days to full enteral feeding (150 ml/kg/day)
研究概览
简要总结
All premature babies have problems with feeding and nutrition. Some can develop a life-threatening bowel infection necrotizing enterocolitis. This can result in the need for emergency surgery, loss of bowel, lifelong feeding problems, and death. Giving premature babies glycerin suppositories may be one way to stimulate the digestive tract and help prevent these problems. To see if this treatment works, the investigators need to study hundreds of premature babies in a large trial involving multiple hospitals. The purpose of this project is to carry out a small study first and make sure that the larger trial is feasible. The investigators will invite approximately 30 premature babies from the Neonatal Intensive Care Unit at McMaster University Medical Centre to participate in this study over a 6-month period. The investigators will focus on feasibility issues, including cost, safety, and rate of participation. This will allow us to rigorously test our study protocol and lay the groundwork for the larger study involving multiple hospitals.
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
- •Gestational age 24-32 weeks OR
- •Birth weight 500-1500 grams
排除标准
- •Congenital gastrointestinal anomalies
- •Surgery within 48 hours of birth
- •Culture-proven sepsis*
- •Vasopressors within 6 hours of first intervention
- •Nitric oxide
- •Duct-dependent congenital heart defect requiring prostaglandins
- •Suspected coagulopathy (mucosal bleeding from any orifice)
- •Confirmed coagulopathy (any one of the following):
- •International Normalized Ratio greater than 1.4
- •Partial Thromboplastin Time greater than 39 seconds
- •Fibrinogen less than 1.00 grams/liter
- •Thrombocytopenia (platelet count less than 100 x 10^9/liter)**
- •Neutropenia (absolute neutrophil count less than 0.5 x 10^9/liter)
- •Complete meconium evacuation (2 normal bowel movements) within 48 hours of life
- •Parent or legal guardian unable to understand English
- •* C-reactive protein is not an exclusion criteria
- •** Indomethacin alone is not an exclusion criteria
研究组 & 干预措施
Glycerin Suppository
干预措施: Glycerin Suppository (Drug)
Sham Suppository
干预措施: Sham Suppository (Other)
结局指标
主要结局
Days to full enteral feeding (150 ml/kg/day)
时间窗: Up to 4 months
次要结局
- Days to complete meconium evacuation(Up to 4 months)
- Compliance with treatment regimen(Up to 4 months)
- Feeding volume on day 14 of life (ml/kg/day)(14 days)
- Mortality(Up to 4 months)
- Necrotizing enterocolitis(Up to 4 months)
- Culture-proven line sepsis(Up to 4 months)
- Days of parenteral nutrition(Up to 4 months)