Human Milk in Preterm Infants

Augusta University

Status: Enrolling

Conditions: Preterm Birth

Treatments: Dietary Supplement: Human milk fortifier

Study type: Interventional

Funder types: Other

Identifiers

NCT05228535

1813934-2

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 4 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Control

No Intervention group

Description:

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

Intervention

Experimental group

Description:

Introducing human milk fortifier at 1 day

Treatment:

Dietary Supplement: Human milk fortifier