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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02274883
Other study ID # 6027
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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