During the first 7 days of life very small babies will receive the drug metoclopramide or a salt solution through an intravenous line. They will also begin to receive a very small amount of breast milk or formula within the first 72 hours of life, in addition toother nourishment that is provided by an intravenous line, according to standard hospital procedure. We think that the babies who receive...
Date First Received: October 19, 2005
Last Updated: December 14, 2005
Verified by: Lawson Health Research Institute, May 2005
Clinical Trial Phase: Phase 4 | Start Date: March 2002
Overall Status: Completed
Estimated Enrollment: 30
Brief Summary
Official Title: “The Effect of Metoclopramide on Feeding in Very Low Birthweight Newborns : a Randomized, Double Blind, Placebo Controlled Pilot Study and a Proposal for a Multicentre Trial”
Condition Keyword(s):
Intervention(s):
During the first 7 days of life very small babies will receive the drug metoclopramide or a salt solution through an intravenous line. They will also begin to receive a very small amount of breast milk or formula within the first 72 hours of life, in addition toother nourishment that is provided by an intravenous line, according to standard hospital procedure. We think that the babies who receive the medication may reach full oral feeds than babies who receive the salt solution.
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Detailed Clinical Trial Description
Clinically stable, premature babies (birth weight between 500 and 1,250g) will be randomized to receive metoclopramide (0.1 mg/kg IV q8h)or an equal volume of placebo for 7 days.A transition feeding schedule will begin within the first 72 hours of life. The time to full feeds for the 2 groups will be analyzed.
Intervention(s) in this Clinical Trial
- Drug: Metoclopramide
Outcome Measures for this Clinical Trial
Primary Measures
- Days required to attainment of full feeds.
Secondary Measures
- Weight at full enteral feeds (g).
- Weight at discharge (g).
- Duration of TPN (days).
- Length of stay(days).
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- birth weight 500 to 1,250g
- clinically stable
- no contraindications to initiating minimal enteral feeding
Exclusion Criteria:
- birth weight > 1,250g
- clinically unstable
- any major congenital anomaly
- significant GI pathology
- severe IUGR
- cholestasis
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 7 Days
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Lawson Health Research Institute
Overall Clinical Trial Officials and Contacts
Orlando daSilva, MD Principal Investigator University of Westen Ontario
Related Publications
References
Kearns GL, van den Anker JN, Reed MD, Blumer JL. Pharmacokinetics of metoclopramide in neonates. J Clin Pharmacol. 1998 Feb;38(2):122-8.
Additional Information
Information obtained from ClinicalTrials.gov on August 27, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00242450
Study ID Number: R-02-012
ClinicalTrials.gov Identifier: NCT00242450
Health Authority: Canada: Health Canada
Clinical Trials Authorship and Review
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