NCT05546814

Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 25 Weeks – 30 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-08
• Primary completion: 2025-04-14
• Completion: 2025-04-14
• First posted: 2022-09-21
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States