Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 224
- Locations
- 2
- Primary Endpoint
- Weight gain
Study Overview
Brief Summary
The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day
Detailed Description
The proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). This is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 1 Month (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks
Exclusion Criteria
- •Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support
Outcomes
Primary Outcomes
Weight gain
Time Frame: baseline to average 12 weeks of age
Average change in weight between baseline and 12 weeks
Secondary Outcomes
- Length of stay(36 weeks or discharge)
- Change in length z score(36 weeks or discharge)
- Length(baseline to average 12 weeks of age)
- Caloric intake(36 weeks)
- Change in weight z score(36 weeks or discharge)
- Mid arm circumference(baseline to average 12 weeks of age)
- Head circumference(baseline to average 12 weeks of age)
- Change in head circumference z score(36 weeks or discharge)
- Rates of infants less than 10th percentile for weight(36 weeks or discharge)
Investigators
Colm Travers
Principal Investigator
University of Alabama at Birmingham