- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05228535
Human Milk in Preterm Infants
July 19, 2022 updated by: Augusta University
Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zanna Wynter, DO
- Phone Number: 770-608-0868
- Email: zwynter@augusta.edu
Study Locations
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Recruiting
- Children's Hospital of Georgia
-
Contact:
- Zanna Wynter, DO
- Email: zwynter@augusta.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 days (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Continue current NICU feeding protocol, introducing human milk fortifier at 8 days
|
|
Experimental: Intervention
Introducing human milk fortifier at 1 day
|
Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Growth velocity
Time Frame: at 28 days of life
|
weight gain in grams/kg/day
|
at 28 days of life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Growth velocity
Time Frame: at 36 weeks post menstrual age
|
weight gain in grams/kg/day
|
at 36 weeks post menstrual age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2022
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
January 14, 2022
First Submitted That Met QC Criteria
January 27, 2022
First Posted (Actual)
February 8, 2022
Study Record Updates
Last Update Posted (Actual)
July 21, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1813934-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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