Recruiting

Human Milk

Sponsor:

Augusta University

Code:

NCT05228535

Conditions

Preterm Birth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Human milk fortifier

Study Details

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.

Conditions

Preterm Birth

Study ID

NCT05228535

Start date

Apr 11, 2022

Status verified date

Jul, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

Continue current NICU feeding protocol, introducing human milk fortifier at 8 days

experimental: Intervention

Introducing human milk fortifier at 1 day

Interventions

Human milk fortifier

Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds

Primary outcome measure

  • Growth velocity [ Time Frame: at 28 days of life ]

Central Contacts and Locations

Central contacts

Zanna Wynter, DO

770-608-0868zwynter@augusta.edu

Locations

Children's Hospital of Georgia

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Zanna Wynter, DO

zwynter@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Jul 21, 2022

Last verified

Jul, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2022-07-21.