Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome
NCT ID: NCT05546814
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2023-02-08
2025-04-14
Brief Summary
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from this study will help us develop a better treatment for in the future.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Sodium algorithm
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.
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
Control
Subjects will be cared for by current protocols
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Gestational age at least 25 0/7weeks but less than 30 weeks.
* \<14 days of age at time of randomization
Exclusion Criteria
* 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.
25 Weeks
30 Weeks
ALL
Yes
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Jeffrey Segar
Principal Investigator
Principal Investigators
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Jeffrey Segar, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Children's wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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IRBNet 1846631
Identifier Type: -
Identifier Source: org_study_id
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