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Human Milk Oligosaccharide

2'-fucosyllactose for Premature Birth (2'FL Trial)

N/A

Recruiting

Led By Ethan Mezoff, MD

Research Sponsored by Nationwide Children's Hospital

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 nicu course (or from birth thru 36 weeks pma)

Awards & highlights

2'FL Trial Summary

This trial will test if 2'-Fucosyllactose given to premature infants will help with development. 90 infants will be randomly given the Fucosyllactose or a placebo and will be compared at the end of the study for neurological development.

2'FL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ nicu course (or from birth thru 36 weeks pma)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~nicu course (or from birth thru 36 weeks pma)

This trial's timeline: 3 weeks for screening, Varies for treatment, and nicu course (or from birth thru 36 weeks pma) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Head circumference in centimeters

Height in centimeters

Weight in kilograms

Secondary outcome measures

Time to full enteral feedings

2'FL Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Treatment with 2'flExperimental Treatment1 Intervention

Receiving of the 2'fucosyllactose supplement

Group II: PlaceboPlacebo Group1 Intervention

Receiving of the placebo: dextrose

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,413 Total Patients Enrolled

8 Trials studying Premature Birth

7,435 Patients Enrolled for Premature Birth

Ethan Mezoff, MDPrincipal Investigator - Nationwide Children's Hospital

Nationwide Children's Hospital

Wright State University School Of Medicine (Medical School)

Frequently Asked Questions

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

What is the sample size of this clinical trial?

"Affirmative. According to data available on clinicaltrials.gov, this research is actively soliciting participants since it was initially posted in July 2018 and recently edited in January 2021. The trial requires 90 volunteers at one medical site for completion."

Answered by AI

Are there any remaining opportunities to join this clinical investigation?

"Affirmative. Clinicaltrials.gov showcases that this medical trial is currently looking for volunteers to join, and the project was first posted on July 4th 2018 with its last update occurring at January 19th 2021. 90 patients are expected to be enrolled from 1 site only."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of Human Milk Oligosaccharide 2'-Fucosyllactose

Ethan Mezoff 2018. "The Impact of Human Milk Oligosaccharide 2'-Fucosyllactose". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04718662.