Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT03614468
Brief 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.
Study:
NCT03614468
Study Brief:
Protocol Section:
NCT03614468