Metoclopramide Pilot Trial
Metoclopramide Pilot Trial
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.
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 Subjects can be withdrawn from the study if meet one of the following criteria: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
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