Metoclopramide Use in Very Low Birth Weight Newborns

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00242450
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 40
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Mar 1, 2002
• Actual Study Completion Date: Jul 1, 2005

Outcome Measures

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). []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 72 Hours to 7 Days
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT00242450
• Other Study ID Numbers: R-02-012
• First Posted: Oct 20, 2005
• Last Update Posted: Aug 25, 2017
• Last Verified: May 1, 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: metoclopramide; feeding; very low birthweightnewborn
• Additional relevant MeSH terms: Metoclopramide

Study Results

No Results Posted as of Aug 25, 2017