Clinical trial NCT05508750: Growth and Safety Clinical Trial on a New Infant Formula
Official title: A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Keywords: infant
formula
in-home
Lead sponsor: Jovie USA, LLC
Sponsor class: INDUSTRY
Collaborators: name: IQVIA RDS Inc.
name: ObvioHealth
First posted: 2022-08-19
Enrollment: 420
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Weight gain from baseline to 16 weeks feeding
timeFrame: 16 weeks
Secondary outcomes:
measure: Length gain from baseline to 16 weeks feeding
timeFrame: 16 weeks
measure: Head Circumference gain from baseline to 16 weeks feeding
timeFrame: 16 weeks
measure: Volume of formula consumed during 3-consecutive day intervals
timeFrame: 16 weeks
Other outcomes:
measure: Assessment of AEs
timeFrame: 16 weeks
measure: Caregiver report of tolerance obtained during 3-consecutive day intervals
timeFrame: 16 weeks
measure: Caregiver report of stool characteristics obtained during 3-consecutive day intervals
timeFrame: 16 weeks
measure: Stool collection for microbiome testing
timeFrame: 16 weeks
Locations:
city: New York
country: United States
facility: ObvioHealth
state: New York
Study officials:
affiliation: ObvioHealth
name: Parth Shah, MD FAPCR
role: PRINCIPAL_INVESTIGATOR
affiliation: IQVIA RDS Inc.
name: Dawn Ross, Director Clinical Project Management
role: STUDY_DIRECTOR
References: