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Metoclopramide Use in Very Low Birth Weight Newborns

L

Lawson Health Research Institute

Status and phase

Completed
Phase 4

Conditions

Infant, Premature

Treatments

Drug: Metoclopramide

Study type

Interventional

Funder types

Other

Identifiers

NCT00242450
R-02-012

Details and patient eligibility

About

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 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.

Sex

All

Ages

72 hours to 7 days old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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