Metoclopramide Use in Very Low Birth Weight Newborns - Full Text View

Sponsored by:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00242450

Purpose

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.

Condition	Intervention	Phase
Infant, Premature	Drug: Metoclopramide	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
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

Resource links provided by NLM:

Drug Information available for: Metoclopramide hydrochloride Metoclopramide

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Days required to attainment of full feeds.

Secondary Outcome Measures:

Weight at full enteral feeds (g).
Weight at discharge (g).
Duration of TPN (days).
Length of stay(days).

Estimated Enrollment:	30
Study Start Date:	March 2002
Estimated Study Completion Date:	July 2005

Detailed 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.

Eligibility

Ages Eligible for Study:	up to 7 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242450

Locations

Canada, Ontario
St Joseph's Hospital
London, Ontario, Canada, N6A 4V2

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Principal Investigator:

Orlando daSilva, MD

University of Westen Ontario

More Information

Publications:

Kearns GL, van den Anker JN, Reed MD, Blumer JL. Pharmacokinetics of metoclopramide in neonates. J Clin Pharmacol. 1998 Feb;38(2):122-8.

Study ID Numbers:	R-02-012, R3356A01
Study First Received:	October 19, 2005
Last Updated:	December 14, 2005
ClinicalTrials.gov Identifier:	NCT00242450 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

metoclopramide
feeding
very low birthweightnewborn

Study placed in the following topic categories:

Body Weight
Birth Weight
Signs and Symptoms
Neurotransmitter Agents
Dopamine

Antiemetics
Dopamine Agents
Peripheral Nervous System Agents
Metoclopramide

Additional relevant MeSH terms:

Birth Weight
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Antagonists
Metoclopramide

Pharmacologic Actions
Body Weight
Signs and Symptoms
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009