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Dietary Supplement

Human Milk Cream for Extremely Premature Infants

N/A
Waitlist Available
Led By Amy B Hair, MD
Research Sponsored by Baylor College of Medicine
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 from birth to death or discharge from the neonatal icu, assessed up to 5 months
Awards & highlights

Study Summary

This trial is testing whether adding a human milk-based caloric supplement to the diet of premature infants will shorten their initial hospital stay.

Who is the study for?
This trial is for extremely premature infants with a birth weight between 500-1250g. They must start enteral feeding before day 14 and parenteral nutrition by day 2 of life. Infants already in another nutritional study or with severe health issues like congenital heart disease are not eligible.Check my eligibility
What is being tested?
The trial tests if adding human milk-derived cream to the diet of premature infants can shorten their hospital stay, especially those developing Bronchopulmonary Dysplasia (BPD). It compares standard human milk diets against those supplemented with this cream.See study design
What are the potential side effects?
While specific side effects are not detailed, monitoring will be essential for any adverse reactions due to the introduction of the cream supplement in these vulnerable infants' diets.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from birth to death or discharge from the neonatal icu, assessed up to 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth to death or discharge from the neonatal icu, assessed up to 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Length of Stay
Secondary outcome measures
Incidence of Bronchopulmonary dysplasia and relationship to postmenstrual age at discharge in infants who received cream supplement

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cream Supplement groupExperimental Treatment1 Intervention
Infants randomized to the cream supplement group will receive an exclusive HM-based diet with the addition of a HM-derived cream caloric supplement.
Group II: Control GroupActive Control1 Intervention
Infants randomized to the Control group will receive the standard regimen of an exclusive HM-based diet (no cream supplement).

Find a Location

Who is running the clinical trial?

Akron Children's HospitalOTHER
48 Previous Clinical Trials
5,008,384 Total Patients Enrolled
St. John Hospital & Medical CenterOTHER
2 Previous Clinical Trials
148 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
903 Previous Clinical Trials
320,767 Total Patients Enrolled
2 Trials studying Bronchopulmonary Dysplasia
60 Patients Enrolled for Bronchopulmonary Dysplasia

Media Library

Bronchopulmonary Dysplasia Research Study Groups: Control Group, Cream Supplement group

Frequently Asked Questions

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

How many medical institutions are participating in this clinical research?

"This clinical trial is lodged in multiple medical centres such as Baylor College of Medicine / Texas Children's Hospital in Houston, Children's Hospital Medical Center of Akron in Boardman and Wasatch Neonatal in Orem. Additionally, there are seven other locations hosting this research initiative."

Answered by AI

Are there currently open spots available in this medical experiment?

"Sadly, the clinical trial's page on clinicialtrials.gov reveals that it is no longer recruiting patients; the original post was created on June 10th 2015 and last updated October 6th 2022. Nevertheless, there are other 55 trials still enrolling candidates at this time."

Answered by AI
Recent research and studies
The Journal of PediatricsJournal
Randomized Trial of Human Milk Cream as a Supplement to Standard Fortification of an Exclusive Human Milk-based Diet in Infants 750-1250 G Birth Weight
Hair, Amy B., Cynthia L. Blanco, Alvaro G. Moreira, Keli M. Hawthorne, Martin L. Lee, David J. Rechtman, and Steven A. Abrams. 2014. “Randomized Trial of Human Milk Cream as a Supplement to Standard Fortification of an Exclusive Human Milk-based Diet in Infants 750-1250 G Birth Weight”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2014.07.005.
Breastfeeding MedicineJournal
Greater Mortality and Morbidity in Extremely Preterm Infants Fed a Diet Containing Cow Milk Protein Products
Abrams, Steven A., Richard J. Schanler, Martin L. Lee, David J. Rechtman, and the Prolacta Study Group. 2014. “Greater Mortality and Morbidity in Extremely Preterm Infants Fed a Diet Containing Cow Milk Protein Products”. Breastfeeding Medicine. Mary Ann Liebert Inc. doi:10.1089/bfm.2014.0024.
Seminars in PerinatologyJournal
The Role of Nutrition in the Prevention and Management of Bronchopulmonary Dysplasia
Biniwale, Manoj A., and Richard A. Ehrenkranz. 2006. “The Role of Nutrition in the Prevention and Management of Bronchopulmonary Dysplasia”. Seminars in Perinatology. Elsevier BV. doi:10.1053/j.semperi.2006.05.007.
The Journal of PediatricsJournal
An Exclusively Human Milk-based Diet Is Associated with a Lower Rate of Necrotizing Enterocolitis Than a Diet of Human Milk and Bovine Milk-based Products
Sullivan, Sandra, Richard J. Schanler, Jae H. Kim, Aloka L. Patel, Rudolf Trawöger, Ursula Kiechl-Kohlendorfer, Gary M. Chan, et al.. 2010. “An Exclusively Human Milk-based Diet Is Associated with a Lower Rate of Necrotizing Enterocolitis Than a Diet of Human Milk and Bovine Milk-based Products”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2009.10.040.
~21 spots leftby Apr 2025
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