Metoclopramide Use in Very Low Birth Weight Newborns

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's30 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Infant, Premature

Interventions

MetoclopramideDRUG

Eligibility

Sex: ALLMin age: 72 HoursMax age: 7 Days

Medical Language ↔ Plain English

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

Locations (1)

St Joseph's Hospital

London, Ontario, Canada

Outcomes

Primary Outcomes

Days required to attainment of full feeds.

Secondary Outcomes

Weight at full enteral feeds (g).

Weight at discharge (g).

Duration of TPN (days).

Length of stay(days).

Data from ClinicalTrials.gov

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