The Effect of Feeding Infant Formula With Enriched Protein Fractions

Cognitive Ability, General Clinical Trial

Official title:

The Effect of Feeding Infant Formula With Enriched Protein Fractions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274883
• Other study ID #: 6027
• Status: Completed
• Phase: N/A
• First received: October 16, 2014
• Last updated: August 31, 2017
• Start date: November 2014
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: May 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Ability, General

Intervention

Dietary Supplement:
• Enriched Protein Fractions
Enriched protein fractions
• Protein Fractions
Protein fractions

Locations

Country	Name	City	State
China	Fuyang Fifth People's Hospital	Fuyang	Anhui
China	Fuyang Maternal and Child Health Institute	Fuyang	Anhui
China	Yinquan Maternal and Child Health Institute	Fuyang	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

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