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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Preterm infant weight gain

Secondary outcome measures

Microbiome

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,553 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants in this clinical trial?

"Affirmative. The information accessible on clinicaltrials.gov confirms that this medicinal study, which was first offered on November 1st 2022, is actively recruiting volunteers. Around 30 participants must be enrolled from a single medical centre."

Answered by AI

Who has been granted access to participate in this trial?

"The research team is currently looking for 30 participants who were born prematurely between 25 and 30 weeks. To qualify, these newborns must have weighed more than 500 grams at birth, been randomised in the first 14 days after delivery, and met certain gestational age criteria."

Answered by AI

Are participants still being welcomed to join this experiment?

"Confirmed. Clinicaltrials.gov provides evidence that this research program, which was initially made public on November 1st 2022, is actively searching for participants. The trial needs to recruit 30 individuals from a single location."

Answered by AI

Can persons aged over 50 years partake in the experiment?

"This clinical trial has specified that prospective participants must be between 25 and 30 Weeks old. The study is open to 184 minors and 74 seniors who meet the requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome

Jeffrey Segar 2023. "Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05546814.

All > Microbiome