The Effect of Feeding Infant Formula With Enriched Protein Fractions

Not Applicable

Completed

• Conditions: Cognitive Ability, General
• Interventions: Dietary Supplement: Enriched Protein Fractions; Dietary Supplement: Protein Fractions

• Registration Number: NCT02274883
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Detailed Description

To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Study Timeline

• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Study Start: 2014-11
• Primary Completion: 2016-10
• Study Completion: 2017-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 451

Inclusion Criteria

• 10-14 days of age
• Exclusively formula-fed
• Singleton birth
• Gestational age of 37-42 weeks
• Birth weight of 2500g to 4000g
• Signed Informed Consent Form

Exclusion Criteria

• History of underlying metabolic or chronic disease
• Congenital malformation
• Condition which is likely to interfere with food ingestion, normal growth, development and evaluation
• Evidence of feeding difficulties or intolerance
• Immunocompromised
• Head/brain disease/injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enriched Protein Fractions	Enriched Protein Fractions	This group is given Infant formula with enriched protein fractions.
Protein Fractions	Protein Fractions	This group is given Infant formula with protein fractions.

Primary Outcome Measures

Name	Time	Method
Infant cognitive development	At 12 months of age	Cognitive Scale of Bayley-III is used as the assessment tool.

Secondary Outcome Measures

Name	Time	Method
Infant cognitive development	At 18 months of age	Cognitive Scale of Bayley-III is used as the assessment tool.
Infant language and motor skills	At 4, 6, 9, 12 and 18 months of age	Ages and Stages Questionnaire, MacArthur-Bates Communicative Development Index, Language Scale and Motor Scale of Bayley-III are used as the assessment tool.
Infant acquisition of social and emotional milestones and adaptive development	At 4, 6, 9, 12 and 18 months of age	Ages and Stages Questionnaire, social-emotional scale and adaptive behavior scale of Bayley-III are used as assessment tool.
Infant temperament	At 12 and 18 months of age	Carey Scale is used as assessment tool.
Infant attention capabilities	At 12 and 18 months of age	Single Object Attention and Free Play Tasks is used as assessment tool.
Physical development	At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age	Body weight, length and head circumference are measured.
Stool characteristics	At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age	According to the recall of parents during the last 24 hours.
Formula intake	At 30, 42, 60, 90, 120, 180, 275 and 365 days of age	According to the recall of parents during the last 24 hours.
Fecal microbiome and metabolome profile	Average of 14 days of age and 120 days of age	Fecal microbiome analysis is done at average of 14 days and 120 days of age. While metabolome profile analysis is done at only average of 120 days of age.
Medically-confirmed Adverse Events	Up to 19 months of age

Trial Locations

Locations (3)

Fuyang Fifth People's Hospital; 🇨🇳 Fuyang, Anhui, China

Yinquan Maternal and Child Health Institute; 🇨🇳 Fuyang, Anhui, China

Fuyang Maternal and Child Health Institute; 🇨🇳 Fuyang, Anhui, China