Clinical trial NCT05546814: Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome
Official title: Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome in Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two cohorts; experimental and control
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preterm infant weight gain
timeFrame: 8 weeks
Secondary outcomes:
measure: Microbiome
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Jeffrey Segar, MD
role: PRINCIPAL_INVESTIGATOR
References: