Newborns Supplemented With Gentle-UHT Donor Milk
Not Applicable
Completed
- Conditions
- Breast Milk ExpressionNewborns
- Interventions
- Other: Gentle-UHT donor human milk supplementation
- Registration Number
- NCT04492579
- Lead Sponsor
- LactaLogics, Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supplementation of Gentle-UHT donor milk Gentle-UHT donor human milk supplementation Supplementation of Gentle-UHT donor milk in addition to mother's own milk, as recommended by the health care providers.
- Primary Outcome Measures
Name Time Method Weight gain 8-9 days of life Average weights compared to WHO data
- Secondary Outcome Measures
Name Time Method Exclusive human milk diet 8-9 days of life Rates of infants still on an exclusive human milk diet
Trial Locations
- Locations (1)
LactaLogics, Inc.
🇺🇸Port Saint Lucie, Florida, United States