The Effect of a New Infant Formula on Growth and Cognition in Healthy Term Infants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Child Development
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Basic Science
Participation Requirements
- Age
- Younger than 30 years
- Gender
- Both males and females
Description
Primary Objective Compare measures of normal, healthy mental development at 365 days of age among infants receiving an investigational formula, infants receiving the control and breastfed group. Secondary Objectives To compare between the two study groups: Measures of mental development up to 365 da...
Primary Objective Compare measures of normal, healthy mental development at 365 days of age among infants receiving an investigational formula, infants receiving the control and breastfed group. Secondary Objectives To compare between the two study groups: Measures of mental development up to 365 days of age Rate of body weight, length and head circumference gain Achieved weight, length and head circumference Stool characteristics, tolerance and formula acceptance Fecal microbiome analysis Antibiotic treatment Medically-confirmed adverse
Tracking Information
- NCT #
- NCT04508257
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Gong Zhang, M.D., Ph.D. Anhui Medical University Affiliated Children's Hospital, China
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