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NCT05546814 Clinical Trial

Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome

Preterm Birth Clinical Trial

Official title:
Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05546814
Other study ID # IRBNet 1846631
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 8, 2023
Est. completion date December 2025

Study information
Verified date March 2024
Source Medical College of Wisconsin
Contact Jeffrey Segar, MD
Phone 414-266-6820
Email jsegar@mcw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Weeks to 30 Weeks
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Sodium algorithm
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

Locations
Country Name City State
United States Children's wisconsin Milwaukee Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Preterm infant weight gain To determine the relationship among sodium intake, bodily growth and the gut in preterm infants 8 weeks
Secondary Microbiome Microbiome diversity according to study group 8 weeks
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