Metoclopramide Use in Very Low Birth Weight Newborns

Infant, Premature Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242450
• Other study ID #: R-02-012
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2005
• Last updated: August 24, 2017
• Start date: March 2002
• Est. completion date: July 2005

Study information

• Verified date: May 2005
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature

Intervention

Drug:
• Metoclopramide

Locations

Country	Name	City	State
Canada	St Joseph's Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days required to attainment of full feeds.
Secondary	Weight at full enteral feeds (g).
Secondary	Weight at discharge (g).
Secondary	Duration of TPN (days).
Secondary	Length of stay(days).