Very Preterm and Extremely Preterm BirthSAFENCT07562997
Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants
A study testing Urine sodium testing, Serum sodium testing and Milk fortification in people with Very Preterm and Extremely Preterm Birth, run by University of Washington at 3 sites in United States.
Trial summary
The goal of the trial is to learn if targeted sodium supplementation (including blood and urine sodium testing) versus standard milk fortification (including blood sodium testing) improves growth and body composition in very preterm infants? Read more about this study
- Who is it for?
- Ages 0 to 14 days
- Conditions the study is for
- Very Preterm and Extremely Preterm Birth
- What is being tested?
- Urine sodium testing, Serum sodium testing and Milk fortification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 May 2026to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted to the University of Washington, Oregon Health and Sciences, or University of Cincinnati NICU at 14 days of age
- Born between 24w0days and 31w6d
- Achieved full enteral feeding
Who cannot join
- Congenital or chromosomal anomalies affecting growth
- Acute renal insufficiency (KDIGO stage 1 or higher)
- Necrotizing enterocolitis (modified Bell's stage IIA or higher)
- Anticipated NICU stay less than 30 days
- Enrollment in a concurrent interventional study that may confound study outcomes
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Debbie Ng, MPH contact
United States3 sites, 3 recruiting
- Not yet recruiting
University of Cincinnati
Cincinnati, Ohio, 45221
Ting Ting Fu, MD, 513-636-4200, futn@ucmail.uc.edu
- Not yet recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Brian Scottoline, MD, PhD, (503) 494-8122, scottoli@ohsu.edu
- Recruiting
University of Washington
Seattle, Washington, 98195
Katie M Strobel, MD, MSCR, (206) 543-3200, kmstrob@uw.edu
D Taylor Hendrixson, MD, MPH
About this study
The goal of the trial is to learn if targeted sodium supplementation (including blood and urine sodium testing) versus standard milk fortification (including blood sodium testing) improves growth and body composition in very preterm infants?
Read the detailed description
Very preterm infants (born <32 weeks gestational age) are at high risk for postnatal growth faltering, which is associated with adverse neurodevelopmental outcomes. Despite routine use of enriched human milk fortification in the NICU, many infants fail to achieve adequate somatic and lean mass growth. Sodium depletion has been identified as a potentially modifiable contributor to this problem: renal tubular immaturity in preterm infants results in obligate urinary sodium wasting. Total body sodium depletion has been associated with poor growth in infants and poor muscle mass development in animal studies.
Current NICU practice relies primarily on serum sodium to guide supplementation; however, serum sodium is a late and insensitive marker of total body sodium depletion. Urine sodium is a more sensitive indicator of sodium balance and may identify depletion before serum levels fall. Gestational-age-specific urine sodium thresholds to guide supplementation have recently been proposed (Stalter et al., 2025), but have evaluated body composition in a prospective randomized trial.
This trial tests whether a structured, urine sodium-guided supplementation protocol based on every other week urine and serum sodium monitoring improves anthropometric growth and lean mass accrual compared to standard enriched fortification alone. The intervention runs from day of life 14 through 36 weeks postmenstrual age, with tapering through 38 weeks PMA.
Body composition assessment incorporates two complementary modalities: serial point-of-care ultrasound (POCUS) of the biceps, rectus femoris, and subcutaneous fat for longitudinal lean and fat mass tracking, and Air Displacement Plethysmography (PeaPod) at 36 weeks postmenstrual age or discharge for criterion-standard whole-body composition. Fat mass, fat-free mass, and body fat percentage will be referenced against the Norris et al. preterm normative curves.
The trial uses an open-label design with block randomization stratified by gestational age. A Data Safety and Monitoring Board will conduct oversight and interim safety reviews.
- Conditions
- Very Preterm and Extremely Preterm Birth
- Being tested
- Urine sodium testing, Serum sodium testing, Milk fortification
- Keywords
- growth, body composition, sodium monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine sodium testingDiagnostic test
The investigators will utilize urine sodium testing every two weeks in conjunction with serum sodium testing to determine if sodium supplementation is indicated.
Serum sodium testingDiagnostic test
The investigators will use serum sodium testing to determine if sodium supplementation or adjustments to sodium supplementation need to be made.
Milk fortificationDietary supplement
The investigators will provide milk fortification using either a bovine-based or a human-milk-based fortifier (per unit protocol), based on growth trajectories.
| Study group | Role | What they receive |
|---|---|---|
| Targeted sodium supplementation | Experimental | Every two weeks serum sodium and urine sodium testing with sodium supplementation if indicated by algorithm. Milk fortification per growth metrics. Receives: Diagnostic Test: Urine sodium testing; Diagnostic Test: Serum sodium testing; Dietary Supplement: Milk fortification |
| Enriched Milk Fortification | Active comparator | Serum sodium testing every two weeks with sodium supplementation if indicated by clinical team. Milk fortification per growth metrics. Receives: Diagnostic Test: Serum sodium testing; Dietary Supplement: Milk fortification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition by point-of-care ultrasound
Evaluate muscle and subcutaneous fat accretion from enrollment to 36 weeks posmtnestrual age. The study team will perform biceps and rectus femoris cross-sectional area measurements using point-of-care ultrasound every 2 weeks. We will perform arm and mid-thigh subcutaneous fat measurements using point-of-care ultrasound every 2 weeks.
Measured: Enrollment to study completion, on average 4-10 weeks
Secondary outcomes (1)
Body composition using air-displacement plethysmography
We will conduct air-displacement plethysmography when the infant is off of oxygen at 36 weeks postmenstrual age or prior to discharge, whichever comes earlier.
Measured: At study completion, on average 4-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start18 May 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Preterm and Extremely Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Strobel, University of Washington
- Investigators
- Katie Strobel, MD, MSCR, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562997
- Sponsor's protocol ID
- STUDY00023657
- Acronym
- SAFE
- Status last verified
- May 2026
- First submitted
- 31 Mar 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study and planned analyses are complete, we will submit de-identified participant data to a public database such as Zenodo.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants
- ClinicalTrials.gov ID
- NCT07562997
- Acronym / sponsor ID
- SAFE / STUDY00023657
- Conditions
- Very Preterm and Extremely Preterm Birth
- Keywords
- growth, body composition, sodium monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 1 May 2026 (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 goal of the trial is to learn if targeted sodium supplementation (including blood and urine sodium testing) versus standard milk fortification (including blood sodium testing) improves growth and body composition in very preterm infants?
Detailed description
Very preterm infants (born <32 weeks gestational age) are at high risk for postnatal growth faltering, which is associated with adverse neurodevelopmental outcomes. Despite routine use of enriched human milk fortification in the NICU, many infants fail to achieve adequate somatic and lean mass growth. Sodium depletion has been identified as a potentially modifiable contributor to this problem: renal tubular immaturity in preterm infants results in obligate urinary sodium wasting. Total body sodium depletion has been associated with poor growth in infants and poor muscle mass development in animal studies.
Current NICU practice relies primarily on serum sodium to guide supplementation; however, serum sodium is a late and insensitive marker of total body sodium depletion. Urine sodium is a more sensitive indicator of sodium balance and may identify depletion before serum levels fall. Gestational-age-specific urine sodium thresholds to guide supplementation have recently been proposed (Stalter et al., 2025), but have evaluated body composition in a prospective randomized trial.
This trial tests whether a structured, urine sodium-guided supplementation protocol based on every other week urine and serum sodium monitoring improves anthropometric growth and lean mass accrual compared to standard enriched fortification alone. The intervention runs from day of life 14 through 36 weeks postmenstrual age, with tapering through 38 weeks PMA.
Body composition assessment incorporates two complementary modalities: serial point-of-care ultrasound (POCUS) of the biceps, rectus femoris, and subcutaneous fat for longitudinal lean and fat mass tracking, and Air Displacement Plethysmography (PeaPod) at 36 weeks postmenstrual age or discharge for criterion-standard whole-body composition. Fat mass, fat-free mass, and body fat percentage will be referenced against the Norris et al. preterm normative curves.
The trial uses an open-label design with block randomization stratified by gestational age. A Data Safety and Monitoring Board will conduct oversight and interim safety reviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted sodium supplementation | Experimental | Diagnostic Test: Urine sodium testing, Diagnostic Test: Serum sodium testing, Dietary Supplement: Milk fortificationEvery two weeks serum sodium and urine sodium testing with sodium supplementation if indicated by algorithm. Milk fortification per growth metrics. |
| Enriched Milk Fortification | Active comparator | Diagnostic Test: Serum sodium testing, Dietary Supplement: Milk fortificationSerum sodium testing every two weeks with sodium supplementation if indicated by clinical team. Milk fortification per growth metrics. |
Who may qualify
- Ages
- 0 to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Admitted to the University of Washington, Oregon Health and Sciences, or University of Cincinnati NICU at 14 days of age
- Born between 24w0days and 31w6d
- Achieved full enteral feeding
Key exclusion criteria (5 listed)
- Congenital or chromosomal anomalies affecting growth
- Acute renal insufficiency (KDIGO stage 1 or higher)
- Necrotizing enterocolitis (modified Bell's stage IIA or higher)
- Anticipated NICU stay less than 30 days
- Enrollment in a concurrent interventional study that may confound study outcomes
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 |
|---|---|---|
| Urine sodium testingThe investigators will utilize urine sodium testing every two weeks in conjunction with serum sodium testing to determine if sodium supplementation is indicated. | Diagnostic test | Targeted sodium supplementation |
| Serum sodium testingThe investigators will use serum sodium testing to determine if sodium supplementation or adjustments to sodium supplementation need to be made. | Diagnostic test | Enriched Milk Fortification, Targeted sodium supplementation |
| Milk fortificationThe investigators will provide milk fortification using either a bovine-based or a human-milk-based fortifier (per unit protocol), based on growth trajectories. | Dietary supplement | Enriched Milk Fortification, Targeted sodium supplementation |
Primary outcome
Body composition by point-of-care ultrasound
Time frame: Enrollment to study completion, on average 4-10 weeks
Evaluate muscle and subcutaneous fat accretion from enrollment to 36 weeks posmtnestrual age. The study team will perform biceps and rectus femoris cross-sectional area measurements using point-of-care ultrasound every 2 weeks. We will perform arm and mid-thigh subcutaneous fat measurements using point-of-care ultrasound every 2 weeks.
1 secondary outcome
Body composition using air-displacement plethysmography
Time frame: At study completion, on average 4-10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. Once the study and planned analyses are complete, we will submit de-identified participant data to a public database such as Zenodo.
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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.
Debbie Ng, MPH contact
Katie Strobel, MD, MSCR principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine sodium testing, Serum sodium testing and Milk fortification in people with Very Preterm and Extremely Preterm Birth, run by University of Washington at 3 sites 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Feltner, MS ((206) 543-3200, jfeltner@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition by point-of-care ultrasound (time frame: Enrollment to study completion, on average 4-10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2026.