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Targeted Milk Fortification for Premature Infants

N/A
Recruiting
Led By Mandy B Belfort, MD, MPH
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronologic age <21 days
Gestational age 24 0/7 to 30 6/7 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years' corrected age
Awards & highlights

Study Summary

This trial is comparing 2 methods of fortifying human milk for preterm infants. Outcomes include physical growth, brain structure, and neurodevelopment.

Who is the study for?
This trial is for preterm infants in Brigham and Women's Hospital NICU, born between 24 to nearly 31 weeks of gestation, less than 21 days old, with mothers providing breast milk. It excludes those with major birth defects, severe growth issues, certain gastrointestinal conditions, multiples beyond twins, life-threatening health status or expected transfer before reaching 36 weeks postmenstrual age.Check my eligibility
What is being tested?
The study compares two human milk fortification methods for premature babies: standard care versus targeted fortification based on real-time milk analysis. The goal is to see which method better supports physical growth and brain development up to the age of two years.See study design
What are the potential side effects?
Since this trial involves nutrition rather than medication or invasive procedures, side effects are not typical as seen in drug trials. However, there may be potential risks associated with nutritional imbalances if the fortification does not meet individual needs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am less than 21 days old.
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My pregnancy is between 24 and 30 weeks.
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I am less than 21 days old.
Select...
My pregnancy is between 24 and 30 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years' corrected age
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years' corrected 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
Bayley-III cognitive score
Bayley-III motor score
Cerebellar volume
+3 more
Secondary outcome measures
Bayley-III language score
Behavioral difficulties
Behavioral inhibition
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Individually targeted fortificationExperimental Treatment1 Intervention
Standard of care fortification plus extra protein and/or calories to ensure that "base" milk has protein 1 g/dL and calories 67/dL.
Group II: Standard fortificationActive Control1 Intervention
Standard of care fortification with multicomponent human milk fortifier (24 kcal/oz) and liquid protein (0.27 g/dL); additional protein and/or calories added only for growth faltering.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,602 Previous Clinical Trials
11,463,095 Total Patients Enrolled
9 Trials studying Premature Birth
973 Patients Enrolled for Premature Birth
Mandy B Belfort, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Individually targeted fortification Clinical Trial Eligibility Overview. Trial Name: NCT03977259 — N/A
Premature Birth Research Study Groups: Standard fortification, Individually targeted fortification
Premature Birth Clinical Trial 2023: Individually targeted fortification Highlights & Side Effects. Trial Name: NCT03977259 — N/A
Individually targeted fortification 2023 Treatment Timeline for Medical Study. Trial Name: NCT03977259 — N/A

Frequently Asked Questions

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

Are there any openings available to join this research endeavor?

"Confirmed. The clinical trial, which was initially posted on January 31st 2020 is currently searching for patients and will last until June 9th 2022. This research project requires the recruitment of 130 participants from a single medical centre."

Answered by AI

What aims is this research endeavor striving to achieve?

"This clinical trial seeks to measure the Bayley-III motor score over a 36 week period. As secondary objectives, it also aims to assess Behavioral inhibition via Mommies and Babies task, Low Bayley-III cognitive scores based on composite scoring lower than 85 (1 standard deviation below normal) as well as Executive function using the Behavioral Rating Inventory of Executive Function - Preschool Version; higher numbers indicating greater difficulty with executive functions."

Answered by AI

What is the current participant count for this experiment?

"Affirmative. Clinicaltrials.gov confirms that the trial, which was initially registered on January 31st 2020, is still recruiting patients for its research. At this juncture it requires 130 participants from just a single medical centre to be enrolled in the study."

Answered by AI

Is eligibility for this research limited to those aged 60 or younger?

"This experiment is open to participants who are younger than 21 Days and older than 0 Days."

Answered by AI

Who would qualify to become part of this medical experiment?

"This research is enrolling 130 infants aged 0 days to 21 days with nutrition disorder. Most notably, participants need to be admitted in the NICU of Brigham and Women's Hospital, have a gestational age between 24 weeks and 30 6/7 weeks, chronologic age below 21 days, and mothers providing breast milk."

Answered by AI
~20 spots leftby Dec 2024