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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04337710
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Active, not recruiting
Phase N/A
Start date May 27, 2021
Completion date July 2025

See also
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