Premature; Infant, Light-for-datesENACTNCT04337710
Exclusive Enteral Nutrition in Preterm Neonates
A study testing Exclusive Enteral Nutrition and Progressive Enteral Nutrition in people with Premature; Infant, Light-for-dates and Enteral Feeding Intolerance, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 hour to 48 hours
- Conditions the study is for
- Premature; Infant, Light-for-dates, Enteral Feeding Intolerance
- What is being tested?
- Exclusive Enteral Nutrition and Progressive Enteral Nutrition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 28 and 32 weeks of gestation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial
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.
Read the 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).
- Being tested
- Exclusive Enteral Nutrition, Progressive Enteral Nutrition
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive Enteral NutritionProcedure or surgery
Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.
Progressive Enteral NutritionProcedure or surgery
Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Exclusive Enteral Nutrition | Experimental | 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. Receives: Procedure: Exclusive Enteral Nutrition |
| Progressive Enteral Nutrition | Active comparator | 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. Receives: Procedure: Progressive Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Birth to 28 days
Secondary outcomes (12)
Time to establish full enteral feeding
Time interval between birth and full enteral feeding at 150ml/kg/day
Measured: 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
Measured: Birth to 28 days
Number of days receiving parenteral nutrition and IV fluids
Measured: Birth to 28 days
Number of days receiving central line access
Measured: Birth to 28 days
Number of episodes of culture proven sepsis
Positive blood cultures
Measured: 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
Measured: Birth to 60 days or discharge, whichever occurs first
Number of participants with diagnosis of intestinal perforation
Pneumoperitoneum on abdominal radiograph
Measured: Birth to 14 days
Death
Measured: Birth to 60 days
Weight
Weekly measurements of weight in g
Measured: Birth to 60 days
Length
Weekly measurements of length in cm
Measured: Birth to 60 days
Head circumference
Weekly measurements of head circumference in cm
Measured: Birth to 60 days
Duration of hospital stay in days
Measured: Birth to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start27 May 2021
- Primary completion12 Sep 2022
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature; Infant, Light-for-datesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariel A. Salas, University of Alabama at Birmingham
- Investigators
- Vivek Shukla, MD, Study chair, University of Alabama at BirminghamAriel Salas, MD, MSPH, Study director, University of Alabama at BirminghamJacqueline Razzaghy, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337710
- Sponsor's protocol ID
- IRB-300004922
- Acronym
- ENACT
- Status last verified
- Jun 2026
- First submitted
- 3 Apr 2020
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salas AA, Stewart CJ, Young GR. Early gut microbiome composition of very preterm infants randomised to receive human milk volumes of 60 ml/kg/day or more within the first 36 hours after birth. Pediatr Res. 2026 Jun;99(5):1964-1969. doi: 10.1038/s41390-025-04456-5. Epub 2025 Oct 2.
PubMed 41034647Razzaghy J, Shukla VV, Gunawan E, Reeves A, Nguyen K, Salas AA. Early and exclusive enteral nutrition in infants born very preterm. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):378-383. doi: 10.1136/archdischild-2023-325969.
PubMed 38135494
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04337710
- Acronym / sponsor ID
- ENACT / IRB-300004922
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusive Enteral Nutrition | Experimental | Procedure: Exclusive Enteral NutritionThis 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. |
| Progressive Enteral Nutrition | Active comparator | Procedure: Progressive Enteral NutritionThis 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. |
Who may qualify
- Ages
- 1 hour to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age between 28 and 32 weeks of gestation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exclusive Enteral NutritionMom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours. | Procedure or surgery | Exclusive Enteral Nutrition |
| Progressive Enteral NutritionMom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours. | Procedure or surgery | Progressive Enteral Nutrition |
Primary outcome
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
12 secondary outcomes
Time to establish full enteral feeding
Time frame: Birth to 28 days
Number of episodes of feeding intolerance
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
Time frame: Birth to 60 days or discharge, whichever occurs first
Number of participants with diagnosis of necrotizing enterocolitis
Time frame: Birth to 60 days or discharge, whichever occurs first
Number of participants with diagnosis of intestinal perforation
Time frame: Birth to 14 days
Death
Time frame: Birth to 60 days
Weight
Time frame: Birth to 60 days
Length
Time frame: Birth to 60 days
Head circumference
Time frame: Birth to 60 days
Duration of hospital stay in days
Time frame: Birth to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 41034647Salas AA, Stewart CJ, Young GR. Early gut microbiome composition of very preterm infants randomised to receive human milk volumes of 60 ml/kg/day or more within the first 36 hours after birth. Pediatr Res. 2026 Jun;99(5):1964-1969. doi: 10.1038/s41390-025-04456-5. Epub 2025 Oct 2.
- Results publication: PubMed 38135494Razzaghy J, Shukla VV, Gunawan E, Reeves A, Nguyen K, Salas AA. Early and exclusive enteral nutrition in infants born very preterm. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):378-383. doi: 10.1136/archdischild-2023-325969.
- CommentaryLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Premature; Infant, Light-for-dates
Active, not recruiting
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Infant Malnutrition, Light-For-Dates With Signs of Fetal Malnutrition
Active, not recruiting
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Prematurity, Light-For-Dates
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Shukla, MD study chair
University of Alabama at Birmingham
Ariel Salas, MD, MSPH study director
University of Alabama at Birmingham
Jacqueline Razzaghy, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exclusive Enteral Nutrition and Progressive Enteral Nutrition in people with Premature; Infant, Light-for-dates and Enteral Feeding Intolerance, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth (time frame: Birth to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337710, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.