Clinical trial NCT02098915: Metoclopramide Pilot Trial
Official title: The Use of Metoclopramide vs. Placebo in Infants With Gastroschisis. A Pilot Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastroschisis
Keywords: gastroschisis
intestinal motility
prokinetic agents
intravenous metoclopramide
time to full enteral feeding
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2014-03-28
Enrollment: 10
Sex: ALL
Minimum age (years): 33
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Days to achieve full enteral feeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
measure: Duration until initiation of enteral feeds
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Duration on parenteral nutrition
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Weight gain
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Occurrence of adverse effects
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Rate of catheter-related sepsis episodes
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Incidence of necrotizing enterocolitis (NEC)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Duration of hospitalization
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: University of Toronto
name: Jacob C Langer, MD
role: PRINCIPAL_INVESTIGATOR
References: