ENACT: Exclusive Enteral Nutrition in Preterm Neonates
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exclusive Enteral Nutrition This group will receive enteral feeding volumes at a rate of 60-80 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day. |
Procedure: Exclusive Enteral Nutrition
Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.
|
| Active Comparator: Progressive Enteral Nutrition This group will receive enteral feeding volumes at a rate of 20-30 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day. |
Procedure: Progressive Enteral Nutrition
Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.
|
Outcome Measures
Primary Outcome Measures
- Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth [Birth to 28 days]
Days of full feeds in the first 28 days after birth
Secondary Outcome Measures
- Time to establish full enteral feeding [Birth to 28 days]
Time interval between birth and full enteral feeding at 150ml/kg/day
- Number of episodes of feeding intolerance [Birth to 28 days]
Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
- Number of days receiving parenteral nutrition and IV fluids [Birth to 28 days]
- Number of days receiving central line access [Birth to 28 days]
- Number of episodes of culture proven sepsis [Birth to 60 days or discharge, whichever occurs first]
Positive blood cultures
- Number of participants with diagnosis of necrotizing enterocolitis [Birth to 60 days or discharge, whichever occurs first]
Diagnosis of necrotizing enterocolitis stage 2 or 3
- Number of participants with diagnosis of intestinal perforation [Birth to 14 days]
Pneumoperitoneum on abdominal radiograph
- Death [Birth to 60 days]
- Weight [Birth to 60 days]
Weekly measurements of weight in g
- Length [Birth to 60 days]
Weekly measurements of length in cm
- Head circumference [Birth to 60 days]
Weekly measurements of head circumference in cm
- Duration of hospital stay in days [Birth to 60 days]
Other Outcome Measures
- Intestinal microbiome profile [At postnatal day 14]
Determined by molecular analyses of bacterial fragments in fecal samples
- Fat-free mass z score [At postnatal day 14]
Determined by air-displacement plethysmography
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
Sponsors and Collaborators
- University of Alabama at Birmingham
Investigators
- Study Chair: Vivek Shukla, MD, University of Alabama at Birmingham
- Study Director: Ariel Salas, MD, MSPH, University of Alabama at Birmingham
- Principal Investigator: Jacqueline Razzaghy, MD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 300004922