Metoclopramide Use in Very Low Birth Weight Newborns
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 Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|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|
- Days required to attainment of full feeds.
- Weight at full enteral feeds (g).
- Weight at discharge (g).
- Duration of TPN (days).
- Length of stay(days).
|Study Start Date:||March 2002|
|Estimated Study Completion Date:||July 2005|
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.
|St Joseph's Hospital|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator:||Orlando daSilva, MD||University of Westen Ontario|