Metoclopramide Use in Very Low Birth Weight Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00242450
Recruitment Status : Completed
First Posted : October 20, 2005
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Infant, Premature Drug: Metoclopramide Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Actual Study Start Date : March 2002
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Primary Outcome Measures :
  1. Days required to attainment of full feeds.

Secondary Outcome Measures :
  1. Weight at full enteral feeds (g).
  2. Weight at discharge (g).
  3. Duration of TPN (days).
  4. Length of stay(days).

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242450

Canada, Ontario
St Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Orlando daSilva, MD University of Westen Ontario

Responsible Party: Lawson Health Research Institute Identifier: NCT00242450     History of Changes
Other Study ID Numbers: R-02-012
First Posted: October 20, 2005    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: May 2005

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lawson Health Research Institute:
very low birthweightnewborn

Additional relevant MeSH terms:
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action