An interventional study of Exclusive Enteral Nutrition and Progressive Enteral Nutrition in Premature; Infant, Light-for-dates and Enteral Feeding Intolerance, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 1 Hour to 48 Hours. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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.
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).
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 102 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 60-80 ml/kg/day after randomization within the first 24 hours.
Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.
Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth
Days of full feeds in the first 28 days after birth
Time frame: Birth to 28 days
Time to establish full enteral feeding
Time interval between birth and full enteral feeding at 150ml/kg/day
Time frame: Birth to 28 days
Number of episodes of feeding intolerance
Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
Time frame: Birth to 28 days
Number of days receiving parenteral nutrition and IV fluids
Time frame: Birth to 28 days
Number of days receiving central line access
Time frame: Birth to 28 days
Number of episodes of culture proven sepsis
Positive blood cultures
Time frame: Birth to 60 days or discharge, whichever occurs first
Number of participants with diagnosis of necrotizing enterocolitis
Diagnosis of necrotizing enterocolitis stage 2 or 3
Time frame: Birth to 60 days or discharge, whichever occurs first
Number of participants with diagnosis of intestinal perforation
Pneumoperitoneum on abdominal radiograph
Time frame: Birth to 14 days
Death
Time frame: Birth to 60 days
Weight
Weekly measurements of weight in g
Time frame: Birth to 60 days
Length
Weekly measurements of length in cm
Time frame: Birth to 60 days
Head circumference
Weekly measurements of head circumference in cm
Time frame: Birth to 60 days
Duration of hospital stay in days
Time frame: Birth to 60 days
Intestinal microbiome profile
Determined by molecular analyses of bacterial fragments in fecal samples
Time frame: At postnatal day 14
Fat-free mass z score
Determined by air-displacement plethysmography
Time frame: At postnatal day 14
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham