Human Milk Fortification in Very Low Birth Neonates
Human Milk Fortification and Feeding Intolerance in Very Low Birth Weight Neonates
2 other identifiers
interventional
100
1 country
1
Brief Summary
The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 12, 2013
CompletedFirst Posted
Study publicly available on registry
November 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJuly 29, 2015
July 1, 2015
1.4 years
November 12, 2013
July 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The days to reach full enteral feeding volume (140 ml/kg/day).
4 - 6 weeks
Secondary Outcomes (7)
Neonatal Outcomes
until 36 weeks PMA
Neonatal Outcomes
until 36 weeks PMA
Neonatal Outcomes
Until full feeding volume
Neonatal Outcomes
Until full feeding volume
Neonatal Outcomes
until 36 weeks PMA
- +2 more secondary outcomes
Study Arms (2)
Fortification at 20 ml/kg/day feeding volume
ACTIVE COMPARATORHuman milk fortifiers will be added to the human milk when neonates reach to feeding volume of 20 ml/kg/day.
Fortification at 100 ml/kg/day feeding volume
ACTIVE COMPARATORhuman milk fortifiers will be added to the human milk when neonates reach to feeding volume of 100 ml/kg/day.
Interventions
Eligibility Criteria
You may qualify if:
- Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).
You may not qualify if:
- Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect.
- Died or extended to die within 48 hours of life
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tennessee, Health Science Center, The Regional Medical Center
Memphis, Tennessee, 38163, United States
Related Publications (1)
Shah SD, Dereddy N, Jones TL, Dhanireddy R, Talati AJ. Early versus Delayed Human Milk Fortification in Very Low Birth Weight Infants-A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:126-131.e1. doi: 10.1016/j.jpeds.2016.03.056. Epub 2016 Apr 23.
PMID: 27112041DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanket D Shah, MBBS
UTHSC, Memphis, TN
- PRINCIPAL INVESTIGATOR
Ajay J Talati, MD
UTHSC, Memphis, TN
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2013
First Posted
November 20, 2013
Study Start
November 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 29, 2015
Record last verified: 2015-07