Newborns Supplemented With Gentle-UHT Donor Milk

LactaLogics

Status: Completed

Conditions: Newborns; Breast Milk Expression

Treatments: Other: Gentle-UHT donor human milk supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04492579

5642622173

Details and patient eligibility

About

This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators aim to determine the safety of GHM, and if GHM provided to breastfeeding mothers of outpatient babies with early weight loss will ensure babies adequately gain weight according to age-matched controls.

Enrollment: 31 patients

Sex: All

Ages: Under 4 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gestational age >36 weeks
• Exclusively fed human milk
• Age <96 hours (4 days)

Exclusion criteria

• Previous admittance to the neonatal intensive care unit
• Supplementation of any formula

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Supplementation of Gentle-UHT donor milk

Experimental group

Description:

Supplementation of Gentle-UHT donor milk in addition to mother's own milk, as recommended by the health care providers.

Treatment:

Other: Gentle-UHT donor human milk supplementation