Infant, Premature
Conditions
Keywords
metoclopramide, feeding, very low birthweightnewborn
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.
Interventions
DRUGMetoclopramide
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
72 Hours to 7 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days required to attainment of full feeds. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight at full enteral feeds (g). | — |
| Weight at discharge (g). | — |
| Duration of TPN (days). | — |
| Length of stay(days). | — |
Countries
Canada
Outcome results
None listed