NCT03614468

New Infant Formula Supports Adequate Growth in Healthy Infants

New Infant Formula Supports Adequate Growth and Safety Study in Healthy Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Worthy Health · Industry
• Sex: All
• Age: 1 Day – 21 Days
• Healthy volunteers: Accepted

Summary

The objective of the present study is to evaluate the growth, safety, and tolerance in healthy, term infants consuming a new to market infant formula (Formula A) and a commercially available infant formula (Formula B) with daily weight gain as the primary outcome. As secondary outcomes, the study will evaluate other growth parameters, tolerance, and safety.

Detailed description

This is a controlled randomized parallel assignment, masked (Participant, Care Provider, Investigator, Outcomes Assessor) study. Healthy infants will be assigned an Investigational (Formula A) experimental new milk based infant formula, or an active comparator Control (Formula B) Enfamil (trademark brand name) marketed milk based infant formula. The period for the study is 365 days (52 weeks) using repeated-measures mixed model (RMMM). Anthropometry, formula intake, tolerance, and stool characteristics will be assessed. Medically confirmed adverse events will be recorded throughout the study.

Conditions

• Infant Development

Interventions

Type	Name	Description
OTHER	Formula A	Formula A is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.
OTHER	Formula B	Formula B is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.

Timeline

• Start date: 2019-05-08
• Primary completion: 2020-05-08
• Completion: 2020-05-25
• First posted: 2018-08-03
• Last updated: 2019-02-26