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Dietary Supplement

Optimized Infant Nutrition for Premature Infants

N/A

Waitlist Available

Led By Luc P Brion, MD

Research Sponsored by University of Texas Southwestern Medical Center

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 at 1 year of age and 3 years of age

Awards & highlights

Study Summary

This trial will compare three different ways of fortifying milk for preterm infants. It will look at whether one method results in better growth and development outcomes than the others.

Who is the study for?

This trial is for preterm infants born before 29 weeks or small for their gestational age (SGA) before 35 weeks, who are at Parkland Health and Hospital System. They must be planned to be breastfed or receive donor milk bank milk. Infants on comfort care, with major birth defects, or too unstable in the first week for accurate measurements can't join.Check my eligibility

What is being tested?

The study tests three ways of fortifying human milk: standard fortification, individualized based on daily nutrient analysis and volume of milk, and optimized based on growth rate and blood tests. It aims to see which method best supports growth in the NICU and long-term health including brain development.See study design

What are the potential side effects?

Since this trial involves nutritional interventions rather than drugs, side effects may not be as pronounced but could include potential digestive issues due to different fortification methods or allergic reactions if donor milk is used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1-3 years of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1-3 years of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1-3 years of age for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Growth Velocity

Linear Growth Velocity

Secondary outcome measures

Assessment of Biomarkers of Adiposity

Assessment of Renal Glomerular Function

Blood Pressure

+10 more

Other outcome measures

Mortality

Necrotizing Enterocolitis

Trial Design

2Treatment groups

Experimental Treatment

Group I: Optimized NutritionExperimental Treatment1 Intervention

Optimized nutrition

Group II: Individualized and Optimized NutritionExperimental Treatment2 Interventions

Individualized nutrition Optimized nutrition

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Individualized Nutrition

2010

N/A

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Gerber FoundationOTHER

41 Previous Clinical Trials

5,876 Total Patients Enrolled

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,679 Total Patients Enrolled

Children's Medical Center DallasOTHER

22 Previous Clinical Trials

5,012,753 Total Patients Enrolled

Media Library

Individualized Nutrition (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT02372136 — N/A

Premature Infant Diseases Research Study Groups: Optimized Nutrition, Individualized and Optimized Nutrition

Premature Infant Diseases Clinical Trial 2023: Individualized Nutrition Highlights & Side Effects. Trial Name: NCT02372136 — N/A

Individualized Nutrition (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02372136 — N/A

Frequently Asked Questions

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

What aims does this clinical trial hope to fulfill?

"The primary analysis of this medical trial spans a 35-37 week period and will observe the growth velocity of participants. Secondary metrics include weight, length, and serum levels of adipokines such as leptin, adiponectin and resistin for comparison with expected values according to age and gender."

Answered by AI

Are there any sign-up opportunities available for the research project?

"As reported on clinicaltrials.gov, this particular medical trial has ceased active recruitment of patients and was last updated on May 10th 2022. Despite the status of this study, there are 19 separate studies actively recruiting candidates at present time."

Answered by AI

Recent research and studies

Journal of PerinatologyJournal

Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants: Double-blinded Randomized Controlled Trial

Brion, Luc P., Charles R. Rosenfeld, Roy Heyne, L. Steven Brown, Cheryl S. Lair, Elen Petrosyan, Theresa Jacob, Maria Caraig, and Patti J. Burchfield. 2020. “Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants: Double-blinded Randomized Controlled Trial”. Journal of Perinatology. Springer Science and Business Media LLC. doi:10.1038/s41372-020-0609-1.

clinicaltrials.govStudy

Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants

Luc P. Brion, MD 2016. "Optimizing Individual Nutrition in Preterm Very Low Birth Weight Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02372136.