Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Metoclopramide Use in Very Low Birth Weight Newborns

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00242450
First received: October 19, 2005
Last updated: December 14, 2005
Last verified: May 2005
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Lawson Health Research Institute:
metoclopramide
feeding
very low birthweightnewborn

Additional relevant MeSH terms:
Metoclopramide
Antiemetics
Autonomic Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014