Clinical trial NCT03055052: Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants
Official title: Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Nutrition
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 160
Sex: ALL
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Growth in terms of weight gain per day
timeFrame: 21 days
Secondary outcomes:
measure: Growth in terms of length and head circumference
timeFrame: Till infant reaches 3kg (study completion), expected within 3 months
measure: Feeding tolerance (frequency of regurgitation, stool frequency and consistency)
timeFrame: Till infant reaches 3kg (study completion), expected within 3 months
measure: Incidence of adverse events
timeFrame: 30 days post infant stopping study infant formula intake upon reaching 3kg
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Tu Du Hospital
state: Ho Chi Minh
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Leslie Tan
role: STUDY_CHAIR
References:
citation: Thanh LQ, Chen Y, Hartweg M, Thi Nguyen TA. Effects of higher protein formula with improved fat blend on growth, feeding tolerance and nutritional biomarkers in preterm infants: A double-blind, randomized, controlled clinical trial. Pediatr Neonatol. 2022 May;63(3):227-238. doi: 10.1016/j.pedneo.2021.09.007. Epub 2021 Dec 4.