Metoclopramide Use in Very Low Birth Weight Newborns
- Conditions
- Infant, Premature
- Registration Number
- NCT00242450
- Lead Sponsor
- Lawson Health Research Institute
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- birth weight 500 to 1,250g
- clinically stable
- no contraindications to initiating minimal enteral feeding
- birth weight > 1,250g
- clinically unstable
- any major congenital anomaly
- significant GI pathology
- severe IUGR
- cholestasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Days required to attainment of full feeds.
- Secondary Outcome Measures
Name Time Method Weight at full enteral feeds (g). Duration of TPN (days). Weight at discharge (g). Length of stay(days).
Trial Locations
- Locations (1)
St Joseph's Hospital
🇨🇦London, Ontario, Canada