The Use of Metoclopramide vs. Placebo in Infants With Gastroschisis. A Pilot Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Days to achieve full enteral feeding
研究概览
简要总结
Infants with gastroschisis typically have poor intestinal motility for the first weeks to months after birth. Prokinetic agents are often used in these infants to improve intestinal motility in an attempt to quicken the attainment of enteric feeds. However, the evidence to support this practice remains weak. Investigators hypothesize that a prokinetic agent given intravenously (infused into a vein) may be effective in improving gut motility in children with gastroschisis.
详细描述
The research question will be addressed in a pilot randomized double-blind placebo controlled clinical trial evaluating the efficacy of metoclopramide.Investigators will recruit 30 neonates (15 per arm) diagnosed with gastroschisis. There will be two arms to the trial: the experimental arm will receive intravenous metoclopramide and the control arm will receive placebo. Patients will receive prokinetic agent therapy, dosed according to weight, or placebo. Each subject will receive the intervention for 28 days or until achievement of full enteral feeding, whichever comes first. Primary outcome: Days to achieve full enteral feeding when all intake (at least 150 ml/kg/day for 72 hours) is given as breast milk or formula by gavage or by mouth. Secondary outcomes: 1. Duration (days) until initiation of enteral feeds. 2. Duration (days) on parenteral nutrition. 3. Weight gain, measured by grams per day per week during therapy. 4. Occurrence of adverse effects associated with the use of metoclopramide. 5. Rate of catheter-related sepsis episodes (line positive blood cultures necessitating antibiotic treatment or catheter removal). 6. Incidence of necrotizing enterocolitis (NEC) based on clinical criteria and presence of pneumatosis intestinalis on an abdominal X-ray. 7. Duration of hospitalization (number of days from admission until final hospital discharge).
Subjects can be withdrawn from the study if meet one of the following criteria:
- Subject develops extrapyramidal symptoms
- Subject has not established full enteral feeding by the end of day 28 of therapy
- Withdrawal of informed consent or refusal of further study participation by parent/legal guardian
- Serious adverse event which, in the opinion of the investigator, indicates that continued participation in the study is not in the best interest of the subject
- Any clinical adverse event, laboratory abnormality or intercurrent illness which, in the opinion of the investigator, indicates that continued participation in the study is not in the best interest of the subject
- Unpredictable discontinuation of metoclopramide drug supply
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 33 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of uncomplicated neonatal gastroschisis treated by primary fascial closure or delayed closure using a pre-formed silo (fascial closure or plastic closure)
- •Expectation of the treating physician that the patient will require intravenous therapy for at least 7 days post-enrolment
排除标准
- •Presence of other significant congenital malformation (ie life-threatening, requiring surgical intervention, or having an effect on intestinal motility)
- •Presence of intestinal atresia, intestinal necrosis or intestinal perforation (ie complicated gastroschisis)
- •Gestational age <32 weeks
- •Birth weight < 1500 gm
- •Received an investigational product within the past 30 days
研究组 & 干预措施
intravenous metoclopramide
the experimental arm will receive intravenous metoclopramide
干预措施: intravenous metoclopramide (Drug)
control arm
the control arm will receive placebo
干预措施: Placebo (Other)
结局指标
主要结局
Days to achieve full enteral feeding
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Days to achieve full enteral feeding will be recorded when all intake (at least 150 ml/kg/day for 72 hours) is given as breast milk or formula by gavage or by mouth
次要结局
- Rate of catheter-related sepsis episodes(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Incidence of necrotizing enterocolitis (NEC)(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Duration of hospitalization(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Duration until initiation of enteral feeds(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Duration on parenteral nutrition(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Weight gain(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
- Occurrence of adverse effects(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
研究者
Jacob Langer
Jacob C Langer, MD, FRCSC
The Hospital for Sick Children