Enteral Nutrition, Fortification, Human Milk, Premature; Infant
Conditions
Brief summary
The purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.
Detailed description
Very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. They need enough calories for catch-up growth. Giving adequate nutrition is very important for their growth and development. Human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). For premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. These extra nutrients will be derived from cow's milk. Currently, a practice of fortifying human milk varies. There is no clear information when to start adding extra nutrients to human milk.
Interventions
DIETARY_SUPPLEMENTHuman milk fortifiers
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Days to 7 Days
Healthy volunteers
No
Inclusion criteria
* Very low birth weight infants who receive human milk (mother's milk or banked donor human milk).
Exclusion criteria
* Major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect. * Died or extended to die within 48 hours of life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The days to reach full enteral feeding volume (140 ml/kg/day). | 4 - 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Outcomes | until 36 weeks PMA | Necrotizing Enterocolitis |
Countries
United States
Outcome results
None listed