Metoclopramide Use in Very Low Birth Weight Newborns

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