Back to resultsHuman Milk in Preterm Infants
Primary Purpose
Preterm Birth
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Human milk fortifier
Sponsored by
About this trial
This is an interventional supportive care trial for Preterm Birth
Eligibility Criteria
Inclusion Criteria:
- Birth weight 1000-1500 grams
- Admitted to NICU within 24 hours of life
- Maternal intent to use human milk
Exclusion Criteria:
- Congenital anomalies
- Feeds not started within the first 96 hours of life
- Intrauterine growth restriction
Sites / Locations
- Children's Hospital of GeorgiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Continue current NICU feeding protocol, introducing human milk fortifier at 8 days
Introducing human milk fortifier at 1 day
Outcomes
Primary Outcome Measures
Growth velocity
weight gain in grams/kg/day
Secondary Outcome Measures
Growth velocity
weight gain in grams/kg/day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05228535
Brief Title
Human Milk in Preterm Infants
Official Title
Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups. 1 group will be controlled, following standard NICU feeding protocol. 1 group will be intervention, receiving early introduction of human milk fortifier to enteral feeds.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Continue current NICU feeding protocol, introducing human milk fortifier at 8 days
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Introducing human milk fortifier at 1 day
Intervention Type
Dietary Supplement
Intervention Name(s)
Human milk fortifier
Intervention Description
Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds
Primary Outcome Measure Information:
Title
Growth velocity
Description
weight gain in grams/kg/day
Time Frame
at 28 days of life
Secondary Outcome Measure Information:
Title
Growth velocity
Description
weight gain in grams/kg/day
Time Frame
at 36 weeks post menstrual age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
4 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Birth weight 1000-1500 grams
Admitted to NICU within 24 hours of life
Maternal intent to use human milk
Exclusion Criteria:
Congenital anomalies
Feeds not started within the first 96 hours of life
Intrauterine growth restriction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zanna Wynter, DO
Phone
770-608-0868
Email
zwynter@augusta.edu
Facility Information:
Facility Name
Children's Hospital of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zanna Wynter, DO
Email
zwynter@augusta.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Human Milk in Preterm Infants
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