Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions

Mead Johnson Nutrition

Status: Completed

Conditions: Cognitive Ability, General

Treatments: Dietary Supplement: Protein Fraction; Dietary Supplement: Enriched Protein Fractions

Study type: Observational

Funder types: Industry

Identifiers

NCT04442477

6027-2

Details and patient eligibility

About

This is a follow-up study of a multi-center, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5 years of age and health outcomes through 5.5 years of age in participants who received one of two staged study formulas through one year of age.

Enrollment: 116 patients

Sex: All

Ages: 64 to 68 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant who previously consumed study formula through one year of age in MJN Project 6027
• 5.5 years of age (i.e. when child turns 5 years and 6 months old ± 2 months) at Visit 1
• Signed informed consent obtained for child's participation in the study

Exclusion criteria

• No exclusion criteria

Trial design

116 participants in 2 patient groups

Experimental: Enriched Protein Fractions

Description:

This group was given Infant formula with enriched protein fractions

Treatment:

Dietary Supplement: Enriched Protein Fractions

Active Comparator: Protein Fractions

Description:

This group was given Infant formula with protein fractions

Treatment:

Dietary Supplement: Protein Fraction