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

Not Applicable

Completed

• Conditions: Infant, Premature, Nutrition
• Interventions: Other: Standard formula for preterm infants; Other: Formula with higher protein and new fat blend for preterm infants

• Registration Number: NCT03055052
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-16
• Primary Completion: 2018-03-18
• Study Completion: 2018-06-25
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Formula	Standard formula for preterm infants	Standard formula for preterm infants.
Experimental formula	Formula with higher protein and new fat blend for preterm infants	Formula with higher protein and new fat blend for preterm infants.

Primary Outcome Measures

Name	Time	Method
Growth in terms of weight gain per day	21 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tu Du Hospital; 🇻🇳 Ho Chi Minh City, Ho Chi Minh, Vietnam