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Completed

NCT Number: NCT00242450

Metoclopramide Use in Very Low Birth Weight Newborns

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.

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Key information

Conditions

Infant, Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

72 hour–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Joseph's Hospital

London, Ontario, N6A 4V2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoclopramide

Drug

Primary outcomes

  1. Days required to attainment of full feeds.

Secondary outcomes

  1. Weight at full enteral feeds (g).

  2. Weight at discharge (g).

  3. Duration of TPN (days).

  4. Length of stay(days).

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2005
First posted
Oct 20, 2005
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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