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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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
635 Previous Clinical Trials
1,181,672 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a structural issue with my urinary system.I am using diuretics and can pause for the study's initial 2 weeks.I am between 25 and 30 weeks pregnant.I am less than 14 days old.My kidney function is impaired (high creatinine levels).
Research Study Groups:
This trial has the following groups:- Group 1: Sodium algorithm
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.