Effect of cow’s milk infant formula on neurodevelopment and growth in infants

Not Applicable

Completed

• Conditions: Infant nutrition; Brain Development in term infants; Neurological - Studies of the normal brain and nervous system; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12616001571460
• Lead Sponsor: Charles Sturt University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-14
• Study Completion: 2017-10-08
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

Healthy full term infants, born at gestational age between 35 and 41 weeks and with a birth body weight between 2500 and 4000 g

Exclusion Criteria

Neonates with Apgar score <7
Neonates with a major birth defect or evidence of genetic disease
Preterm infants (less than 35 weeks)
Term infants born less than 2500 g or more than 4000 g.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurodevelopment<br>The Bayley Scales of Infant and Toddler Development (Bayley II or III) will be used to test neurodeveloping and cognitive function ability of infants. [At 12 months of age]

Secondary Outcome Measures

Name	Time	Method
eurodevelopment<br><br>The Bayley Scales of Infant and Toddler Development (Bayley II or III) will be used to test neurodeveloping and cognitive function ability of infants. [At 6 months of age];Growth assessed by anthropometry measurements [At birth, 42 days, 4 months, 6 months, 8 months and 12 months of age];Gut microbiota, assessed by faecal sample metagenomic sequencing.[at 42 days and 4 months of age];Short term memory (Chinese version) <br><br>The Bayley Scales of Infant and Toddler Development (Bayley II or III) will be used to test neurodeveloping and cognitive function ability of infants. [6 and 12 months of age];formula tolerance assessed by feeding survey. This survey was designed for this study.[42 days, 4 months, 6 months, 8 months and 12 months of age]