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Clinical Trials/NCT05228535
NCT05228535
Unknown
Not Applicable

Early Fortification of Human Milk for Very Low Birth Weight Infants and Effects on Growth Velocity

Augusta University1 site in 1 country50 target enrollmentApril 11, 2022
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ConditionsPreterm Birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Augusta University
Enrollment
50
Locations
1
Primary Endpoint
Growth velocity
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 11, 2022
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Growth velocity

Time Frame: at 28 days of life

weight gain in grams/kg/day

Secondary Outcomes

  • Growth velocity(at 36 weeks post menstrual age)

Study Sites (1)

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