Preterm Birth, Nutrition, Healthy
Conditions
Keywords
newborn, human milk
Brief summary
Preterm and very low birth weight (VLBW, \< 1,500g) infants who receive donor human milk (DHM) often experience slow postnatal growth and no clinical data is available to guide the duration of DHM for preterm infants. The investigators hypothesize that transitioning from DHM to preterm infant formula after the first month of life is both safe and conveys improved weight and length gains and fat free mass accumulation.
Interventions
DIETARY_SUPPLEMENTPreterm Infant Formula
Transition from donor human milk to preterm infant formula
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
28 Days to No maximum
Healthy volunteers
No
Inclusion criteria
1. Greater than 1,250 grams 2. At least 28 days of life 3. Diet consisting of donor human milk with/without mother's own milk
Exclusion criteria
1. Birth weight below the 5th percentile 2. History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder 3. Congenital anomalies 4. Care team discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Velocity | 36 weeks post menstrual age | Weight velocity between birth and 36 weeks post menstrual age |
| Fat free mass | 36 weeks post menstrual age | Fat free mass at 36 weeks post menstrual age |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients with Bronchopulmonary dysplasia | 36 weeks post menstrual age |
| Number of Patients with Retinopathy of prematurity | 36 weeks post menstrual age |
| Number of Patients with Sepsis | 36 weeks post menstrual age |
| Number of Patients with Necrotizing enterocolitis | 36 weeks post menstrual age |
Countries
United States
Outcome results
None listed