Study Stopped
Slow recruitment
Feeding Study in VLBW Premature Infants
Comparison of Multinutrient Human Milk Fortifiers in Preterm Infants: A Non-inferiority Single-blind, Randomized Controlled Trial (RCT)
1 other identifier
interventional
22
1 country
6
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 24, 2023
CompletedStudy Start
First participant enrolled
July 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedJuly 9, 2024
July 1, 2024
11 months
January 31, 2023
July 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Weight gain
grams/kg/day
Daily for 28 days
Secondary Outcomes (11)
Feeding Tolerance
Daily for 28 days
Rate of Length and head circumference gain
weekly up to day 28
Total energy intake
28 days
Total protein intake
28 days
Respiratory status
28 days
- +6 more secondary outcomes
Study Arms (3)
Commercial Liquid Human Milk Fortifier
ACTIVE COMPARATORLiquid human milk fortifier to be added to human milk
Liquid Human Milk Fortifier - Standard Protein
EXPERIMENTALLiquid human milk fortifier to be added to human milk
Liquid Human Milk Fortifier - High Protein
EXPERIMENTALLiquid human milk fortifier to be added to human milk
Interventions
Liquid human milk fortifier to be added to human milk daily
Eligibility Criteria
You may qualify if:
- Clinically and metabolically stable
- Birth weight 700 g to less than or equal to 1,250 g
- Appropriate birth weight for gestational age
- /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
You may not qualify if:
- Metabolic or chronic disease
- minute Apgar score \<4
- Major surgery
- Ventilator dependent
- Fluid restriction
- Grade III or IV intraventricular hemorrhage (IVH)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Augusta University
Augusta, Georgia, 30912, United States
Riley Children's Hospital
Indianapolis, Indiana, 46202, United States
NYU Langone Hospital, Long Island
Mineola, New York, 11501, United States
Cohen Children's Medical Center of NY
New Hyde Park, New York, 11040, United States
Weill Cornell Medicine
New York, New York, 10021, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 24, 2023
Study Start
July 10, 2023
Primary Completion
May 31, 2024
Study Completion
May 31, 2024
Last Updated
July 9, 2024
Record last verified: 2024-07