Metoclopramide Pilot Trial

• Status: Terminated
• Trial end date: 2019-12-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: The Physicians' Services Incorporated Foundation
• Treatments: Metoclopramide

Criteria

Inclusion Criteria:

1. Diagnosis of uncomplicated neonatal gastroschisis treated by primary fascial closure or delayed closure using a pre-formed silo (fascial closure or plastic closure)

2. Expectation of the treating physician that the patient will require intravenous therapy for at least 7 days post-enrolment

Exclusion Criteria:

1. Presence of other significant congenital malformation (ie life-threatening, requiring surgical intervention, or having an effect on intestinal motility)

2. Presence of intestinal atresia, intestinal necrosis or intestinal perforation (ie complicated gastroschisis)

3. Gestational age <32 weeks

4. Birth weight < 1500 gm

5. Received an investigational product within the past 30 days