Premature InfantNCT03586102
Effect of Increased Enteral Protein on Body Composition of Preterm Infants
A study testing High protein supplementation and Standard protein supplementation in people with Premature Infant, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age. Read more about this study
- Who is it for?
- Ages 1 day to 21 days
- Conditions the study is for
- Premature Infant
- What is being tested?
- High protein supplementation and Standard protein supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2018to 24 Apr 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 day to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 25 and 28 weeks of gestation
- Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.
Who cannot join
- Necrotizing enterocolitis (NEC) stage 2 or greater.
- Gastrointestinal or neurologic malformations.
- Terminal illness needing to limit or withhold support will be exclusion criteria.
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: Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
Read the detailed description
Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group).
Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding.
Control group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding.
If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).
- Conditions
- Premature Infant
- Being tested
- High protein supplementation, Standard protein supplementation
- Keywords
- Protein supplementation, Human milk fortification
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein supplementationDietary supplement
To increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive > 4.5 g/kg/day of enteral protein after establishment of full enteral feeding.
Standard protein supplementationDietary supplement
Infants assigned to the standard protein supplementation group will receive fortified human milk (< 4.5 g/kg/day of enteral protein)
| Study group | Role | What they receive |
|---|---|---|
| High protein supplementation | Experimental | Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first. Receives: Dietary Supplement: High protein supplementation |
| Standard protein supplementation | Active comparator | Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first. Receives: Dietary Supplement: Standard protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant body composition
Percent body fat estimated by air displacement plethysmography
Measured: Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age
Secondary outcomes (7)
Infant body composition
Percent body fat estimated by air displacement plethysmography
Measured: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
Growth
Weekly weight gain in grams
Measured: Birth to 3 months of corrected age
Length
Weekly length in cm
Measured: Birth to 3 months of corrected age
Head circumference
Weekly head circumference in cm
Measured: Birth to 3 months of corrected age
Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: Birth to 3 months of corrected age
Necrotizing enterocolitis
Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3
Measured: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
Death
Measured: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start23 Aug 2018
- Primary completion30 Apr 2020
- Study completion24 Apr 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 InfantStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Health System, Alabama
- Responsible party
- Principal investigator, Ariel A. Salas, University of Alabama at Birmingham
- Investigators
- Ariel A. Salas, MD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586102
- Sponsor's protocol ID
- 300000681
- Status last verified
- May 2025
- First submitted
- 1 Jun 2018
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salas AA, Jerome M, Finck A, Razzaghy J, Chandler-Laney P, Carlo WA. Body composition of extremely preterm infants fed protein-enriched, fortified milk: a randomized trial. Pediatr Res. 2022 Apr;91(5):1231-1237. doi: 10.1038/s41390-021-01628-x. Epub 2021 Jun 28.
PubMed 34183770Strobel KM, Jaspan HB, Gibbons SM, Salas AA. Microbial Interactions with Protein Intake and Preterm Infant Body Composition: Secondary Analysis of a Randomized Trial. J Nutr. 2026 Jul 12;156(9):101723. doi: 10.1016/j.tjnut.2026.101723. Online ahead of print.
PubMed 42437569
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial
- ClinicalTrials.gov ID
- NCT03586102
- Acronym / sponsor ID
- 300000681
- Conditions
- Premature Infant
- Keywords
- Protein supplementation, Human milk fortification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Children's Health System, Alabama
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 13 Jul 2018 (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.
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
Detailed description
Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group).
Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding.
Control group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding.
If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein supplementation | Experimental | Dietary Supplement: High protein supplementationInfants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first. |
| Standard protein supplementation | Active comparator | Dietary Supplement: Standard protein supplementationInfants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first. |
Who may qualify
- Ages
- 1 day to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age between 25 and 28 weeks of gestation
- Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.
Key exclusion criteria (3 listed)
- Necrotizing enterocolitis (NEC) stage 2 or greater.
- Gastrointestinal or neurologic malformations.
- Terminal illness needing to limit or withhold support will be exclusion criteria.
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 |
|---|---|---|
| High protein supplementationTo increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive > 4.5 g/kg/day of enteral protein after establishment of full enteral feeding. | Dietary supplement | High protein supplementation |
| Standard protein supplementationInfants assigned to the standard protein supplementation group will receive fortified human milk (< 4.5 g/kg/day of enteral protein) | Dietary supplement | Standard protein supplementation |
Primary outcome
Infant body composition
Time frame: Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age
Percent body fat estimated by air displacement plethysmography
7 secondary outcomes
Infant body composition
Time frame: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)
Growth
Time frame: Birth to 3 months of corrected age
Length
Time frame: Birth to 3 months of corrected age
Head circumference
Time frame: Birth to 3 months of corrected age
Body mass index
Time frame: Birth to 3 months of corrected age
Necrotizing enterocolitis
Time frame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
Death
Time frame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first
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 28 May 2025.
- Background: PubMed 34183770Salas AA, Jerome M, Finck A, Razzaghy J, Chandler-Laney P, Carlo WA. Body composition of extremely preterm infants fed protein-enriched, fortified milk: a randomized trial. Pediatr Res. 2022 Apr;91(5):1231-1237. doi: 10.1038/s41390-021-01628-x. Epub 2021 Jun 28.
- Derived from this study: PubMed 42437569Strobel KM, Jaspan HB, Gibbons SM, Salas AA. Microbial Interactions with Protein Intake and Preterm Infant Body Composition: Secondary Analysis of a Randomized Trial. J Nutr. 2026 Jul 12;156(9):101723. doi: 10.1016/j.tjnut.2026.101723. Online ahead of print.
- Individual participant dataSharing planned: No
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Growing Little PEAPODS Study
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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.
Ariel A. Salas, MD, MSPH 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 High protein supplementation and Standard protein supplementation in people with Premature Infant, 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 2 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 28 May 2025. 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?
Infant body composition (time frame: Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age). 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 NCT03586102, 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 28 May 2025.