Clinical Effects of a Formula With Modified Protein Levels and Fat Blend in Preterm Infants

Nestlé

Status: Completed

Conditions: Infant, Premature, Nutrition

Treatments: Other: Standard formula for preterm infants; Other: Formula with higher protein and new fat blend for preterm infants

Study type: Interventional

Funder types: Industry

Identifiers

NCT03055052

14.25.INF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: Under 33 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

Control Formula

Active Comparator group

Description:

Standard formula for preterm infants.

Treatment:

Other: Standard formula for preterm infants

Experimental formula

Experimental group

Description:

Formula with higher protein and new fat blend for preterm infants.

Treatment:

Other: Formula with higher protein and new fat blend for preterm infants