Growth and Safety Clinical Trial on a New Infant Formula

Jovie USA

Status: Completed

Conditions: Weight Gain

Treatments: Other: New Infant Formula; Other: Commercial Infant Formula

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05508750

IQV-JOV-001

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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420 participants in 3 patient groups

New Infant Formula

Experimental group

Description:

New infant formula for healthy term infants

Treatment:

Other: New Infant Formula

Commercial Infant Formula

Active Comparator group

Description:

Standard, commercially available infant formula for healthy term infants

Treatment:

Other: Commercial Infant Formula

Human Milk

No Intervention group

Description:

Breastfed infants serve as a reference group