Human Milk in Preterm Infants

Sponsor

Augusta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05228535

Collaborator

(none)

Enrollment

Location

Arms

19.7

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Dietary Supplement: Human milk fortifier	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 11, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Dietary Supplement: Human milk fortifier

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

Outcome Measures

Primary Outcome Measures

Growth velocity [at 28 days of life]
weight gain in grams/kg/day

Secondary Outcome Measures

Growth velocity [at 36 weeks post menstrual age]
weight gain in grams/kg/day

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 4 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Georgia	Augusta	Georgia	United States	30912

Sponsors and Collaborators

Augusta University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Augusta University

ClinicalTrials.gov Identifier:

NCT05228535

Other Study ID Numbers:

1813934-2

First Posted:

Feb 8, 2022

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jul 21, 2022