Transition From Donor Milk: a Feasibility Study
Not Applicable
Not yet recruiting
- Conditions
- Nutrition, HealthyPreterm Birth
- Interventions
- Dietary Supplement: Preterm Infant Formula
- Registration Number
- NCT06514014
- Lead Sponsor
- Augusta University
- 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. We 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Greater than 1,250 grams
- At least 28 days of life
- Diet consisting of donor human milk with/without mother's own milk
Exclusion Criteria
- Birth weight below the 5th percentile
- History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
- Congenital anomalies
- Care team discretion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Preterm Infant Formula Preterm Infant Formula -
- Primary Outcome Measures
Name Time Method Fat free mass 36 weeks post menstrual age Fat free mass at 36 weeks post menstrual age
Weight Velocity 36 weeks post menstrual age Weight velocity between birth and 36 weeks post menstrual age
- Secondary Outcome Measures
Name Time Method Retinopathy of prematurity 36 weeks post menstrual age Bronchopulmonary dysplasia 36 weeks post menstrual age Necrotizing enterocolitis 36 weeks post menstrual age Sepsis 36 weeks post menstrual age