NCT05228535

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 14, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

January 14, 2022

Last Update Submit

July 19, 2022

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • Growth velocity

    weight gain in grams/kg/day

    at 28 days of life

Secondary Outcomes (1)

  • Growth velocity

    at 36 weeks post menstrual age

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

Introducing human milk fortifier at 1 day

Dietary Supplement: Human milk fortifier

Interventions

Human milk fortifierDIETARY_SUPPLEMENT

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

Intervention

Eligibility Criteria

AgeUp to 4 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight 1000-1500 grams
  • Admitted to NICU within 24 hours of life
  • Maternal intent to use human milk

You may not qualify if:

  • Congenital anomalies
  • Feeds not started within the first 96 hours of life
  • Intrauterine growth restriction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Georgia

Augusta, Georgia, 30912, United States

RECRUITING

Related Publications (1)

  • Wynter Z, Gorham JA, Thompson AB, Mundy C, Waller JL, Stansfield BK. Immediate fortification of human milk with a bovine milk-derived human milk fortifier in very low birth weight infants: a randomized clinical trial. J Perinatol. 2024 Nov;44(11):1591-1596. doi: 10.1038/s41372-024-01998-0. Epub 2024 May 9.

    PMID: 38724605DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Zanna Wynter, DO

CONTACT

770-608-0868zwynter@augusta.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2022

First Posted

February 8, 2022

Study Start

April 11, 2022

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)