Effects of sodium supplementation on growth and gut health in preterm infants
Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome in Preterm Infants
This study tests if adding sodium to the diets of preterm infants can help them grow better and improve their gut health compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 25 Weeks to 30 Weeks |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05546814 on ClinicalTrials.gov |
What this trial studies
This project aims to investigate the impact of sodium supplementation on the growth and health of preterm infants. Infants will be randomly assigned to receive either sodium supplementation based on a urine sodium concentration algorithm or standard care. The study will monitor nutritional intake and collect stool samples to analyze the intestinal microbiome at various stages. Health information will also be gathered from medical records to assess the overall outcomes of the intervention.
Who should consider this trial
Good fit: Ideal candidates are preterm infants weighing more than 500 grams and born between 25 to 30 weeks of gestation, who are less than 14 days old at the time of randomization.
Not a fit: Patients with major congenital anomalies or significant renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved growth and health outcomes for preterm infants.
How similar studies have performed: Other studies have suggested that sodium supplementation can positively influence growth in preterm infants, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milwaukee, Wisconsin
- Children's wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Segar, MD — Medical College of Wisconsin
- Study coordinator: Jeffrey Segar, MD
- Email: jsegar@mcw.edu
- Phone: 414-266-6820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.