Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome

NCT05546814 | Completed

• 1 other identifier: IRBNet 1846631
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Preterm infant weight gain

  To determine the relationship among sodium intake, bodily growth and the gut in preterm infants

  8 weeks

Secondary Outcomes (1)

• Microbiome

  8 weeks

Study Arms (2)

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

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

Sodium algorithm

Eligibility Criteria

• Age: 25 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)
• any structural genitourinary criteria.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jeffrey Segar, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two cohorts; experimental and control

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: February 8, 2023
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)