Growth, Development, Infant
Conditions
Keywords
infant formula, premature infants, Growth and Development
Brief summary
The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.
Interventions
OTHERinfant formula
test infant formula fed to infants until 6 months corrected gestational age
commercially available infant formula
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No
Inclusion criteria
* Born AGA * Exclusively formula-fed * 28-34 weeks GA at birth * Intact GI tract, tolerating full oral feeds * Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days
Exclusion criteria
* Severe respiratory disease defined as needing mechanical ventilation at discharge * Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions. * Major congenital malformation, history of GI surgery, severe postnatal complications * Daily or routine diuretic use at time of discharge * Receiving more than 10% of daily kcals from food additives such as thickeners * Currently participating or having participated in another conflicting clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth | 4 months | weight gain assessed monthly |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| growth, tolerance, morbidity | 6 months | gains in length and head circumference assessed monthly, tolerance and morbidity throughout study |
| Total body bone mineral content and density and body composition, protein status, and metabolic markers | corrected term and 4 months | — |
Countries
United States
Outcome results
None listed