Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)
Status: Terminated
Location: See all (6) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 7 months
Healthy Volunteers: f
View:
• Clinically and metabolically stable
• Birth weight 700 g to less than or equal to 1,250 g
• Appropriate birth weight for gestational age
• 24 0/7 to 32 0/7 weeks' gestational age at birth
• Exclusively fed human milk
• Signed informed consent and authorization to use and/or disclose PHI
Locations
United States
Alabama
The University of Alabama at Birmingham
Birmingham
Georgia
Augusta University
Augusta
Indiana
Riley Children's Hospital
Indianapolis
New York
NYU Langone Hospital, Long Island
Mineola
Cohen Children's Medical Center of NY
New Hyde Park
Weill Cornell Medicine
New York
Time Frame
Start Date: 2023-07-10
Completion Date: 2024-05-31
Participants
Target number of participants: 22
Treatments
Active_comparator: Commercial Liquid Human Milk Fortifier
Liquid human milk fortifier to be added to human milk
Experimental: Liquid Human Milk Fortifier - Standard Protein
Liquid human milk fortifier to be added to human milk
Experimental: Liquid Human Milk Fortifier - High Protein
Liquid human milk fortifier to be added to human milk
Related Therapeutic Areas
Sponsors
Leads: Mead Johnson Nutrition