Clinical Trial: Metoclopramide Pilot Trial
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Use of Metoclopramide vs. Placebo in Infants With Gastroschisis. A Pilot Double Blind Randomized Controlled Trial
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 Summary:
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Subjects can be withdrawn from the study if meet one of the following criteria: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 opini
Sponsor: The Hospital for Sick Children
Current Primary Outcome: Days to achieve full enteral feeding [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
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
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration until initiation of enteral feeds [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Duration (days) until initiation of enteral feeds will be recorded
- Duration on parenteral nutrition [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Duration (days) on parenteral nutrition will be recorded
- Weight gain [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Weight gain, measured by grams per day per week during therapy will be recorded
- Occurrence of adverse effects [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Occurrence of adverse effects associated with the use of metoclopramide will be recorded.
- Rate of catheter-related sepsis episodes [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Rate of catheter-related sepsis episodes during intravenous treatment (line positive blood cultures necessitating antibiotic treatment or catheter removal) will be recorded.
- Incidence of necrotizing enterocolitis (NEC) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Incidence of necrotizing enterocolitis (NEC) during the therapy based on clinical criteria and presence of pneumatosis intestinalis on an abdominal X-ray will be recorded.
- Duration of hospitalization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Duration of hospitalization (number of days from admission until final hospital discharge) will be recorded.
Original Secondary Outcome:
- Duration until initiation of enteral feeds [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Duration (days) until initiation of enteral feeds will be recorded
- Duration on parenteral nutrition [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Duration (days) on parenteral nutrition will be recorded
- Weight gain [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Weight gain, measured by grams per day per week during therapy will be recorded
- Occurrence of adverse effects [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Occurrence of adverse effects associated with the use of metoclopramide will be recorded.
- Rate of catheter-related sepsis episodes [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Rate of catheter-related sepsis episodes during intravenous treatment (line positive blood cultures necessitating antibiotic treatment or catheter removal) will be recorded.
- Incidence of necrotizing enterocolitis (NEC) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Incidence of necrotizing enterocolitis (NEC) during the therapy based on clinical criteria and presence of pneumatosis intestinalis on an abdominal X-ray will be recorded.
- Duration of hospitalization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Duration of hospitalization (number of days from admission until final hospital discharge) will be recorded.
- Conjugated bilirubin levels [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 4 weeks. Conjugated bilirubin levels will be measured weekly during the therapy.
Information By: The Hospital for Sick Children
Dates:
Date Received: March 21, 2014
Date Started: March 2014
Date Completion: June 2017
Last Updated: January 18, 2017
Last Verified: January 2017
- Duration until initiation of enteral feeds [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
