Preterm Infants
Conditions
Brief summary
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.
Interventions
OTHERExperimental human milk fortifier
Human milk fortifier to be added to human milk feedings
OTHERControl human milk fortifier
Control human milk fortifier to be added to human milk
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Days
Healthy volunteers
No
Inclusion criteria
* 700-1500g birth weight * 33 weeks or less gestational age * Appropriate for gestational age * Initiate enteral feeds of human milk by 21 days of life * Mother provided exclusive human milk feeds * Parents allow both human milk and study human milk fortifier * Singleton or twin birth
Exclusion criteria
* Feeding preterm infant formula or non-study human milk fortifier * Expected at facility less than 15 days * Congenital anomalies/disease affecting growth and development * 5 minute APGAR of 4 or less * Steroid use * ECMO * Grade III or IV PVH/IVH * Mechanical ventilator dependency * Maternal incapacity * History of major surgery * Asphyxia * Confirmed NEC or sepsis * Use of probiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight gain | 29 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric variables | 29 days | Length and head circumference |
| GI tolerance | 29 days | stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc. |
Countries
United States
Outcome results
None listed