Impact of Dietary Sodium Supplementation on Growth & Inte... | NCT05546814

Studies
Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome

NCT05546814

Sponsor

Medical College of Wisconsin

Status

Completed

Last Update Posted

Aug 11, 2025Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Preterm Birth

Interventions

Sodium algorithm

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2023Actual

Primary Completion Date

Apr 14, 2025Actual

Completion Date

Apr 14, 2025Actual

First Submitted Date

Sep 15, 2022

First Submission Date that Met QC Criteria

Sep 19, 2022

First Posted Date

Sep 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2025

Last Update Posted Date

Aug 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeffrey Segar, Principal Investigator, Medical College of WisconsinPrincipal Investigator

Lead Sponsor

Medical College of WisconsinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this project is to determine the direct impact of sodium supplementation in preterm infants and to see the overall improvement of their growth and health status.

from this study will help us develop a better treatment for in the future.

Detailed Description

Premature infants are at an increased risk of postnatal growth failure and as well as developing short or long-term impaired neurodevelopment and cardio metabolic health.

For many years, it has been recognized that ideal growth is attainable with sufficient sodium intake and a positive sodium balance. The results of this study could have a significant impact on the care of preterm infants.

Infants will be randomized into one of two groups. One group will receive sodium supplementation as guided by a urine sodium concentration algorithm, one group will be managed by current standards. Randomization will occur at 2 weeks of postnatal age

Standard of care group Care for the participant will remain the same as if they were not in the study. Nutritional information, including sodium intake will be collected on three separate days weekly for 8 weeks. Stool samples will be collected for determining intestinal microbiome at 2 weeks, 5 weeks, 8 weeks and the day they are discharged from the hospital.

The study team will also collect detailed health information from participants hospital stay from the medical chart. Which will include gestational age, birth weight, sex, race ,ethnicity, mode of delivery and exposure to any steroids, antibiotics and clinical diagnoses.

Sodium supplementation group:

Participants will receive sodium supplementation per the urine sodium concentration algorithm. Urine sodium will be determined weekly, and if urine sodium concentration is below set value, dietary sodium supplementation is provided.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sodium algorithm	Experimental	Starting at 2 weeks of age, the sodium algorithm group will be started based on their sodium levels. This will be adjusted weekly based on weight gain and sodium levels.	Procedure: Sodium algorithm
Control	No Intervention	Subjects will be cared for by current protocols

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium algorithm	Procedure	Infants will receive sodium and follow a sodium supplementation schedule or algorithm. This means that based on the sodium levels collected from the samples (stool and urine) they will receive an increase or maintain the same amount to help

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preterm infant weight gain	To determine the relationship among sodium intake, bodily growth and the gut in preterm infants	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Microbiome	Microbiome diversity according to study group	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Birthweight >500 grams and
Gestational age at least 25 0/7weeks but less than 30 weeks.
<14 days of age at time of randomization

Exclusion Criteria:

Non-English speaking parents
Major congenital anomalies
grade underlying renal dysfunction (serum creatinine > 1.0 mg/dL or increase of >0.3 mg/DL between any two consecutive measurements)
use of diuretics at the time initiation of intervention (approximately 14 days of age) But this is not completely an exclusion-the research can wait 2 days and at the time of 2 week time period of the study we can re check their levels
any structural genitourinary criteria.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Weeks

Maximum Age

30 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Segar, MD	Medical College of Wisconsin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's wisconsin		Milwaukee	Wisconsin	53226	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

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