NCT00242450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2005

Completed
Last Updated

August 25, 2017

Status Verified

May 1, 2005

First QC Date

October 19, 2005

Last Update Submit

August 24, 2017

Conditions

Infant, Premature

Keywords

metoclopramidefeedingvery low birthweightnewborn

Outcome Measures

Primary Outcomes (1)

  • Days required to attainment of full feeds.

Secondary Outcomes (4)

  • Weight at full enteral feeds (g).

  • Weight at discharge (g).

  • Duration of TPN (days).

  • Length of stay(days).

Interventions

MetoclopramideDRUG

Eligibility Criteria

Age72 Hours - 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • birth weight 500 to 1,250g
  • clinically stable
  • no contraindications to initiating minimal enteral feeding

You may not qualify if:

  • birth weight \> 1,250g
  • clinically unstable
  • any major congenital anomaly
  • significant GI pathology
  • severe IUGR
  • cholestasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

Related 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. doi: 10.1002/j.1552-4604.1998.tb04400.x.

    PMID: 9549642BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Orlando daSilva, MD

    University of Westen Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2005

First Posted

October 20, 2005

Study Start

March 1, 2002

Study Completion

July 1, 2005

Last Updated

August 25, 2017

Record last verified: 2005-05

Locations

CA(1)