Growth and Safety Clinical Trial on a New Infant Formula

Not Applicable

Completed

• Conditions: Weight Gain
• Interventions: Other: New Infant Formula; Other: Commercial Infant Formula

• Registration Number: NCT05508750
• Lead Sponsor: Jovie USA, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-19
• Study Start: 2022-09-21
• Status Verified: 2024-01
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Infant Formula	New Infant Formula	New infant formula for healthy term infants
Commercial Infant Formula	Commercial Infant Formula	Standard, commercially available infant formula for healthy term infants

Primary Outcome Measures

Name	Time	Method
Weight gain from baseline to 16 weeks feeding	16 weeks	Weight gain g/day

Secondary Outcome Measures

Name	Time	Method
Length gain from baseline to 16 weeks feeding	16 weeks	Length gain
Head Circumference gain from baseline to 16 weeks feeding	16 weeks	Head Circumference gain
Volume of formula consumed during 3-consecutive day intervals	16 weeks	Volume of formula consumed

Trial Locations

Locations (1)

ObvioHealth; 🇺🇸 New York, New York, United States