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Targeted Milk Fortification for Premature Infants
Study Summary
This trial is comparing 2 methods of fortifying human milk for preterm infants. Outcomes include physical growth, brain structure, and neurodevelopment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have serious kidney or liver problems.I am less than 21 days old.You are a breastfeeding mother.I have a genetic disorder affecting my metabolism.My pregnancy is between 24 and 30 weeks.I have had severe intestinal problems like NEC or a perforation.I am less than 21 days old.My pregnancy is between 24 and 30 weeks.I have been on a fluid intake restriction of less than 140 mL/kg/day for at least 3 days.
- Group 1: Standard fortification
- Group 2: Individually targeted fortification
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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