University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Completed
NCT Number: NCT04337710
Exclusive Enteral Nutrition in Preterm Neonates
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
1 hour–48 hour
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Exclusive Enteral Nutrition
ProcedureMom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.
Progressive Enteral Nutrition
ProcedureMom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.
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
-
Time to establish full enteral feeding
Time frame: Birth to 28 days
Time interval between birth and full enteral feeding at 150ml/kg/day
-
Number of episodes of feeding intolerance
Time frame: 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
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
Time frame: Birth to 60 days or discharge, whichever occurs first
Positive blood cultures
-
Number of participants with diagnosis of necrotizing enterocolitis
Time frame: 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
Time frame: Birth to 14 days
Pneumoperitoneum on abdominal radiograph
-
Death
Time frame: Birth to 60 days
-
Weight
Time frame: Birth to 60 days
Weekly measurements of weight in g
-
Length
Time frame: Birth to 60 days
Weekly measurements of length in cm
-
Head circumference
Time frame: Birth to 60 days
Weekly measurements of head circumference in cm
-
Duration of hospital stay in days
Time frame: Birth to 60 days
Other outcomes
-
Intestinal microbiome profile
Time frame: At postnatal day 14
Determined by molecular analyses of bacterial fragments in fecal samples
-
Fat-free mass z score
Time frame: At postnatal day 14
Determined by air-displacement plethysmography
Sponsors and collaborators
Lead sponsor
University of Alabama at Birmingham
Other
Registry information
Official study title
Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial
Acronym: ENACT
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2025
- First posted
- Apr 8, 2020
- Registry last updated
- Jun 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
The Effect of the Physiotherapy Program Applied in the Neonatal Intensive Care Unit
NCT05845684
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Female Urogenital Diseases and Pregnancy Complications
Samsun, Atakum, Turkey (Türkiye)
View Trial Details
Completed
Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
NCT02915549
Female Urogenital Diseases and Pregnancy Complications, Obstetric Labor Complications
Birmingham, Alabama, United States
View Trial Details
Completed
Cue-based Tactile Stimulation and Infant Stress Reactivity
NCT01121523
Female Urogenital Diseases and Pregnancy Complications, Obstetric Labor Complications
Hershey, Pennsylvania, United States
View Trial Details
Completed
Re-feeding Gastric Residuals in Preterm Infants
NCT01420263
Female Urogenital Diseases and Pregnancy Complications, Obstetric Labor Complications
Birmingham, Alabama, United States
View Trial Details