Metoclopramide Pilot Trial

NCT02098915 | Terminated Phase 3 DMC

• 2 other identifiers: 1000038585169334
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroschisis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Days to achieve full enteral feeding

  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

  Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcomes (7)

• 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

• Rate of catheter-related sepsis episodes

  Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

intravenous metoclopramide

EXPERIMENTAL

the experimental arm will receive intravenous metoclopramide

Drug: intravenous metoclopramide

control arm

PLACEBO COMPARATOR

the control arm will receive placebo

Other: Placebo

Interventions

intravenous metoclopramide DRUG

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

intravenous metoclopramide

Placebo 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

control arm

Eligibility Criteria

• Age: 33 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacob C Langer, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jacob C Langer, MD, FRCSC

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: March 28, 2014
• Study Start: March 1, 2014
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-12

Locations

CA (1)