Metoclopramide Pilot Trial

The Hospital for Sick Children

Status and phase

Terminated

Phase 3

Conditions

Gastroschisis

Treatments

Drug: intravenous metoclopramide

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02098915

1000038585

169334 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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Subjects can be withdrawn from the study if meet one of the following criteria: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

Enrollment

10 patients

Sex

All

Ages

33+ weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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