Weight Gain Clinical Trial
Official title:
A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula
Verified date | January 2024 |
Source | Jovie USA, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 420 |
Est. completion date | January 2, 2024 |
Est. primary completion date | January 2, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 0 Days to 14 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | ObvioHealth | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Jovie USA, LLC | IQVIA RDS Inc., ObvioHealth |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Assessment of AEs | AEs reported during the study | 16 weeks | |
Other | Caregiver report of tolerance obtained during 3-consecutive day intervals | Caregiver report of fussiness, gassiness, and spitting up | 16 weeks | |
Other | Caregiver report of stool characteristics obtained during 3-consecutive day intervals | Caregiver report of stool consistency, color, and frequency | 16 weeks | |
Other | Stool collection for microbiome testing | Stool collection for microbiome testing at week 16 of feeding | 16 weeks | |
Primary | Weight gain from baseline to 16 weeks feeding | Weight gain g/day | 16 weeks | |
Secondary | Length gain from baseline to 16 weeks feeding | Length gain | 16 weeks | |
Secondary | Head Circumference gain from baseline to 16 weeks feeding | Head Circumference gain | 16 weeks | |
Secondary | Volume of formula consumed during 3-consecutive day intervals | Volume of formula consumed | 16 weeks |
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