Metoclopramide Pilot Trial

NCT ID: NCT02098915

Last Updated: 2019-12-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2019-12-12

Brief 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.

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Subjects can be withdrawn from the study if meet one of the following criteria: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

Conditions

Gastroschisis

Keywords

gastroschisis; intestinal motility; prokinetic agents; intravenous metoclopramide; time to full enteral feeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

intravenous metoclopramide

the experimental arm will receive intravenous metoclopramide

Group Type: EXPERIMENTAL

intravenous metoclopramide

Intervention Type: DRUG

the experimental arm will receive intravenous metoclopramide dosed according to the current Sick Kids guidelines based upon weight and age

control arm

the control arm will receive placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

equivalent volume to intravenous metoclopramide (dosed according to the current Sick Kids guidelines based upon weight and age ) of sterile sodium chloride 0.9% injection as a placebo

Interventions

intravenous metoclopramide

the experimental arm will receive intravenous metoclopramide dosed according to the current Sick Kids guidelines based upon weight and age

Intervention Type: DRUG

Placebo

equivalent volume to intravenous metoclopramide (dosed according to the current Sick Kids guidelines based upon weight and age ) of sterile sodium chloride 0.9% injection as a placebo

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 33 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jacob Langer

Jacob C Langer, MD, FRCSC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob C Langer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

169334

Identifier Type: OTHER

Identifier Source: secondary_id

1000038585

Identifier Type: -

Identifier Source: org_study_id