Preterm Infants
Conditions
Brief summary
An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk
Interventions
OTHERPreterm infant formulas and discharge formulas
Preterm infant formulas to be consumed per health care provider orders
OTHERPreterm infant formula with added soluble lipids
Preterm infant formula to be fed per healthcare provider instructions
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Days
Healthy volunteers
No
Inclusion criteria
* Birthweight 500-1800 g * Less than 33 wks gestational age * Enteral feeding initiated by 21 days of life * Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate * Singleton or twin births only * Infant is 21 days of age or less at time of randomization
Exclusion criteria
* Serious congenital abnormalities that may affect growth and development * Grade III or IV intraventricular hemorrhage (IVH) * Maternal incapacity * History of major surgery * Extracorporeal membrane oxygenation (ECMO) * Asphyxia * Confirmed NEC or positive blood cultures at the time of randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants | variable |
Secondary
| Measure | Time frame |
|---|---|
| Measures of eye function, ROP, measures of skin lipid soluble compound concentration | variable |
Countries
United States
Outcome results
None listed