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Human Milk Fortifier
Fortified Breastmilk for Very Low Birth Weight Infants
N/A
Waitlist Available
Research Sponsored by Mead Johnson Nutrition
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 study days 0, 14, 28
Awards & highlights
Study Summary
This trial compares the growth of premature babies who are fed either breastmilk + 1 of 3 types of fortifiers.
Who is the study for?
This trial is for premature infants born between 24 and 32 weeks of gestation, weighing between 700g to 1,250g. They must be stable, fed only human milk, and have parents who consent. Infants with very low Apgar scores, on ventilators, fluid restrictions, severe brain hemorrhage or major surgery are excluded.Check my eligibility
What is being tested?
The study is testing three different human milk fortifiers added to breast milk to see which one supports better growth in very low birth weight (VLBW) preterm infants. It's a multi-center study where babies are randomly assigned to receive one of the fortifiers.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally speaking infant formula can sometimes cause digestive issues like gas or constipation and may lead to allergic reactions if an infant cannot tolerate certain ingredients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study days 0, 14, 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study days 0, 14, 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight gain
Secondary outcome measures
Feeding Tolerance
Incidence of NEC
Incidence of sepsis - Antibiotic use
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Liquid Human Milk Fortifier - Standard ProteinExperimental Treatment1 Intervention
Liquid human milk fortifier to be added to human milk
Group II: Liquid Human Milk Fortifier - High ProteinExperimental Treatment1 Intervention
Liquid human milk fortifier to be added to human milk
Group III: Commercial Liquid Human Milk FortifierActive Control1 Intervention
Liquid human milk fortifier to be added to human milk
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Who is running the clinical trial?
Mead Johnson NutritionLead Sponsor
79 Previous Clinical Trials
15,999 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe brain bleed.I have a long-term health condition.My baby was born weighing between 700g and 1,250g.I have not had major surgery recently.My overall health condition is stable.My baby was born between 24 and 32 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Liquid Human Milk Fortifier - Standard Protein
- Group 2: Commercial Liquid Human Milk Fortifier
- Group 3: Liquid Human Milk Fortifier - High Protein
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the target demographic for this research study limited to individuals aged 30 or older?
"This medical trial is open to participants who are between 168 and 224 days old."
Answered by AI
Who qualifies for enrollment in this experiment?
"The requirements to join this research project are a birth weight below the 10th percentile and an age between 168 days and 224 days. The goal is to recruit 369 infants overall."
Answered by AI
Are there open slots for participants in this research project?
"Data provided on clinicaltrials.gov discloses that this medical trial is not currently seeking new patients, as it was originally posted on February 1st 2023 and last updated 15 days later. Notwithstanding, there are 43 other studies actively recruiting participants at the moment."
Answered by AI
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