Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature; Infant, Light-for-dates
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
To test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged use of parenteral nutrition.
Detailed Description
Qualifying participants will be randomly assigned to one of two study groups: 1) Exclusive Enteral Feeds or 2) Progressive Enteral Feeds with supplemental parenteral nutrition. Regardless of study group assignment, donor human milk will be offered if the mother's expressed breast milk is not enough to complete the intervention as assigned. Intervention group: Feeds will be initiated with a target volume of 60-80 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150ml/kg/day is achieved. Control group: Enteral feeds will be initiated with a target volume of 20-30 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150 ml/kg/day is achieved. If parent agrees, stool "dirty" diapers will be collected 2 times during this study. One time around the time of birth and one time at 28 days or discharge (whichever occurs first).
Investigators
Ariel A. Salas
Assistant Professor
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •Gestational age between 28 and 32 weeks of gestation
Exclusion Criteria
- •Intrauterine growth restriction (birth weight \< 10th percentile)
- •Major congenital or chromosomal anomalies
- •Terminal illness in which decisions to withhold or limit support have been made
Outcomes
Primary Outcomes
Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth
Time Frame: Birth to 28 days
Days of full feeds in the first 28 days after birth
Secondary Outcomes
- Number of days receiving parenteral nutrition and IV fluids(Birth to 28 days)
- Number of days receiving central line access(Birth to 28 days)
- Duration of hospital stay in days(Birth to 60 days)
- Time to establish full enteral feeding(Birth to 28 days)
- Number of participants with diagnosis of necrotizing enterocolitis(Birth to 60 days or discharge, whichever occurs first)
- Length(Birth to 60 days)
- Number of episodes of culture proven sepsis(Birth to 60 days or discharge, whichever occurs first)
- Weight(Birth to 60 days)
- Number of episodes of feeding intolerance(Birth to 28 days)
- Number of participants with diagnosis of intestinal perforation(Birth to 14 days)
- Death(Birth to 60 days)
- Head circumference(Birth to 60 days)