Growth and Safety Clinical Trial on a New Infant Formula
NCT ID: NCT05508750
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
420 participants
INTERVENTIONAL
2022-09-21
2024-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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New Infant Formula
New infant formula for healthy term infants
New Infant Formula
New infant formula fed daily ad libitum
Commercial Infant Formula
Standard, commercially available infant formula for healthy term infants
Commercial Infant Formula
Commercially available infant formula fed daily ad libitum
Human Milk
Breastfed infants serve as a reference group
No interventions assigned to this group
Interventions
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New Infant Formula
New infant formula fed daily ad libitum
Commercial Infant Formula
Commercially available infant formula fed daily ad libitum
Eligibility Criteria
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Inclusion Criteria
* 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 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
0 Days
14 Days
ALL
Yes
Sponsors
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IQVIA RDS Inc.
INDUSTRY
ObvioHealth
INDUSTRY
Jovie USA, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Parth Shah, MD FAPCR
Role: PRINCIPAL_INVESTIGATOR
ObvioHealth
Dawn Ross, Director Clinical Project Management
Role: STUDY_DIRECTOR
IQVIA RDS Inc.
Locations
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ObvioHealth
New York, New York, United States
Countries
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Other Identifiers
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IQV-JOV-001
Identifier Type: -
Identifier Source: org_study_id
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