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Sodium Supplementation for Premature Birth

N/A
Recruiting
Led By Jeffrey Segar, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether sodium supplements can help improve the growth and health status of preterm infants. The results will help guide future treatment for preterm infants.

Who is the study for?
This trial is for preterm infants with a birth weight over 500 grams, born between 25 and less than 30 weeks of gestation, and who are younger than 14 days old at the time they join. Infants with major birth defects, kidney problems indicated by high creatinine levels, or those on diuretics can't participate unless their condition stabilizes.
What is being tested?
The study is testing how adding sodium to the diets of premature babies affects their growth and gut bacteria. Researchers will use an algorithm to decide how much sodium these babies need. The goal is to find out if this helps them grow better.
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include imbalances in electrolytes like high blood sodium which could affect hydration and organ function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Preterm infant weight gain
Secondary study objectives
Microbiome

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sodium algorithmExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Subjects will be cared for by current protocols

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
631 Previous Clinical Trials
1,181,928 Total Patients Enrolled
7 Trials studying Premature Birth
6,884 Patients Enrolled for Premature Birth
Jeffrey Segar, MDPrincipal InvestigatorMedical College of Wisconsin
2 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Sodium algorithm Clinical Trial Eligibility Overview. Trial Name: NCT05546814 — N/A
Premature Birth Research Study Groups: Sodium algorithm, Control
Premature Birth Clinical Trial 2023: Sodium algorithm Highlights & Side Effects. Trial Name: NCT05546814 — N/A
Sodium algorithm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546814 — N/A
~11 spots leftby Dec 2025
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