Breast Milk Expression, Newborns
Conditions
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.
Interventions
OTHERGentle-UHT donor human milk supplementation
Providers referred mothers with newborns that fit the following criteria: exhibited insufficient milk supply, an infant with early weight loss born \>36 weeks gestation. Mother was given Gentle-UHT donor milk for supplementation, in addition to mother's own milk for the first week of the infant's life after hospital discharge.
Sponsors
Renown Regional Medical Center
LactaLogics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain | 8-9 days of life | Average weights compared to WHO data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive human milk diet | 8-9 days of life | Rates of infants still on an exclusive human milk diet |
Countries
United States
Outcome results
None listed