Metoclopramide Use in Very Low Birth Weight Newborns

NCT ID: NCT00242450

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2005-07-31

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.

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.

Conditions

Infant, Premature

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Metoclopramide

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 72 Hours
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Orlando daSilva, MD

Role: PRINCIPAL_INVESTIGATOR

University of Westen Ontario

Locations

St Joseph's Hospital

London, Ontario, Canada

Countries

Canada

References

Kearns GL, van den Anker JN, Reed MD, Blumer JL. Pharmacokinetics of metoclopramide in neonates. J Clin Pharmacol. 1998 Feb;38(2):122-8. doi: 10.1002/j.1552-4604.1998.tb04400.x.

Reference Type: BACKGROUND

PMID: 9549642 (View on PubMed)

Other Identifiers

R-02-012

Identifier Type: -

Identifier Source: org_study_id