Infant, Premature, Nutrition
Conditions
Brief summary
This study evaluates the effects of infant formula with higher protein level and improved fat blend on growth and feeding tolerance in preterm infants. Half of the subjects will receive a standard infant formula, while the other half will receive a infant formula with a higher protein level and improved fat blend.
Detailed description
When an infant is born prematurely, the supply of nutrients supporting normal growth and development is interrupted. There is less time to accrue adequate nutrient stores and foetal tissue. The nutritional goal for the preterm infant is to have satisfactory functional development and catch up on growth to match the rate of a full term infant. To achieve this, it is recommended for the infant to have adequate protein intake and suitable fat blend.
Interventions
OTHERFormula with higher protein and new fat blend for preterm infants
Reconstituted in water and given to infants at more than 50% of feedings.
OTHERStandard formula for preterm infants
Reconstituted in water and given to infants at more than 50% of feedings.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 33 Weeks
Healthy volunteers
No
Inclusion criteria
* Less than or equal to 33 weeks 0 days * Birth weight less than or equal to 2000g. * Infant is anticipated to receive the study formula for ≥ 3 consecutive weeks * At entry into Full Enteral Feeding, study formula will be provided at 50% or more of total enteral feedings. * Written informed consent has been obtained from the parent/legally authorized representative (LAR).
Exclusion criteria
* Peri-/intra-ventricular hemorrhage * Renal disease * Hepatic dysfunction * Major congenital malformations * Suspected or documented systemic or congenital infections * Cardiac, respiratory, endocrinologic, hematologic, GI, or other systemic diseases that may impact growth * Suspected or documented maternal substance abuse * Infants who have received any experimental treatment or intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth in terms of weight gain per day | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Growth in terms of length and head circumference | Till infant reaches 3kg (study completion), expected within 3 months |
| Feeding tolerance (frequency of regurgitation, stool frequency and consistency) | Till infant reaches 3kg (study completion), expected within 3 months |
| Incidence of adverse events | 30 days post infant stopping study infant formula intake upon reaching 3kg |
Countries
Vietnam
Outcome results
None listed