Metoclopramide Use in Very Low Birth Weight Newborns

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double

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.

Interventions

  • Drug: Metoclopramide

Clinical Trial Outcome Measures

Primary Measures

  • Days required to attainment of full feeds.

Secondary Measures

  • Weight at full enteral feeds (g).
  • Weight at discharge (g).
  • Duration of TPN (days).
  • Length of stay(days).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 72 Hours

Maximum Age: 7 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lawson Health Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Orlando daSilva, MD, Principal Investigator, University of Westen Ontario

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.

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