A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula

Jovie USA, LLC1 site in 1 country420 target enrollmentSeptember 21, 2022

ConditionsWeight Gain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Weight Gain
Sponsor: Jovie USA, LLC
Enrollment: 420
Locations: 1
Primary Endpoint: Weight gain from baseline to 16 weeks feeding
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.

Registry

clinicaltrials.gov

Start Date

September 21, 2022

End Date

January 2, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jovie USA, LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Normal term infant (37-42 weeks gestation at birth)
•Infant \<15 (+3) days of age at first study feeding, Birth constitutes day 0
•Infant birth weight of ≥2500 g (5.5 lbs.)
•Healthy Infant
•Caregiver who has previously decided to exclusively feed infant formula or exclusively breastfeed and is willing to continue with current feeding method throughout the study (breastfeeding or formula feeding)
•Caregiver willing to conform to protocol requirements (e.g. measuring, feeding, completion of food intake and tolerance diaries, and reporting of AEs)
•Caregiver willing and able to sign informed consent

Exclusion Criteria

•Infant born in multiple birth (i.e., twins, triplets, etc.)
•Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
•Infant with family history (parents or siblings) of confirmed Milk or Soy allergies
•Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
•Caregiver intent to feed non-study formula or solid food during the study