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OpenTrials
Completed

NCT Number: NCT05546814

Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome

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.

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Key information

Age range

25 week–30 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Preterm infant weight gain

    Time frame: 8 weeks

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

Secondary outcomes

  1. Microbiome

    Time frame: 8 weeks

    Microbiome diversity according to study group

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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