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Growth and Safety Clinical Trial on a New Infant Formula

Primary Purpose

Weight Gain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New Infant Formula
Commercial Infant Formula
Sponsored by
Jovie USA, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Gain focused on measuring infant, formula, in-home

Eligibility Criteria

0 Days - 14 Days (Child)All SexesAccepts 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

Sites / Locations

  • ObvioHealth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

New Infant Formula

Commercial Infant Formula

Human Milk

Arm Description

New infant formula for healthy term infants

Standard, commercially available infant formula for healthy term infants

Breastfed infants serve as a reference group

Outcomes

Primary Outcome Measures

Weight gain from baseline to 16 weeks feeding
Weight gain g/day

Secondary Outcome Measures

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

Full Information

First Posted
August 18, 2022
Last Updated
September 1, 2023
Sponsor
Jovie USA, LLC
Collaborators
IQVIA RDS Inc., ObvioHealth
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1. Study Identification

Unique Protocol Identification Number
NCT05508750
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jovie USA, LLC
Collaborators
IQVIA RDS Inc., ObvioHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain
Keywords
infant, formula, in-home

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New Infant Formula
Arm Type
Experimental
Arm Description
New infant formula for healthy term infants
Arm Title
Commercial Infant Formula
Arm Type
Active Comparator
Arm Description
Standard, commercially available infant formula for healthy term infants
Arm Title
Human Milk
Arm Type
No Intervention
Arm Description
Breastfed infants serve as a reference group
Intervention Type
Other
Intervention Name(s)
New Infant Formula
Intervention Description
New infant formula fed daily ad libitum
Intervention Type
Other
Intervention Name(s)
Commercial Infant Formula
Intervention Description
Commercially available infant formula fed daily ad libitum
Primary Outcome Measure Information:
Title
Weight gain from baseline to 16 weeks feeding
Description
Weight gain g/day
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Length gain from baseline to 16 weeks feeding
Description
Length gain
Time Frame
16 weeks
Title
Head Circumference gain from baseline to 16 weeks feeding
Description
Head Circumference gain
Time Frame
16 weeks
Title
Volume of formula consumed during 3-consecutive day intervals
Description
Volume of formula consumed
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Assessment of AEs
Description
AEs reported during the study
Time Frame
16 weeks
Title
Caregiver report of tolerance obtained during 3-consecutive day intervals
Description
Caregiver report of fussiness, gassiness, and spitting up
Time Frame
16 weeks
Title
Caregiver report of stool characteristics obtained during 3-consecutive day intervals
Description
Caregiver report of stool consistency, color, and frequency
Time Frame
16 weeks
Title
Stool collection for microbiome testing
Description
Stool collection for microbiome testing at week 16 of feeding
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parth Shah, MD FAPCR
Organizational Affiliation
ObvioHealth
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dawn Ross, Director Clinical Project Management
Organizational Affiliation
IQVIA RDS Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ObvioHealth
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Growth and Safety Clinical Trial on a New Infant Formula

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