Preterm Birth
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHuman milk fortifier
Human milk fortifier added to human breast milk at day 1 vs day 8 of feeds
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth velocity | at 28 days of life | weight gain in grams/kg/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth velocity | at 36 weeks post menstrual age | weight gain in grams/kg/day |
Countries
United States
Contacts
Primary ContactZanna Wynter, DO
Outcome results
None listed