NCT05508750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

August 18, 2022

Last Update Submit

January 15, 2024

Conditions

Weight Gain

Keywords

infantformulain-home

Outcome Measures

Primary Outcomes (1)

  • Weight gain from baseline to 16 weeks feeding

    Weight gain g/day

    16 weeks

Secondary Outcomes (3)

  • Length gain from baseline to 16 weeks feeding

    16 weeks

  • Head Circumference gain from baseline to 16 weeks feeding

    16 weeks

  • Volume of formula consumed during 3-consecutive day intervals

    16 weeks

Other Outcomes (4)

  • Assessment of AEs

    16 weeks

  • Caregiver report of tolerance obtained during 3-consecutive day intervals

    16 weeks

  • Caregiver report of stool characteristics obtained during 3-consecutive day intervals

    16 weeks

  • +1 more other outcomes

Study Arms (3)

New Infant Formula

EXPERIMENTAL

New infant formula for healthy term infants

Other: New Infant Formula

Commercial Infant Formula

ACTIVE COMPARATOR

Standard, commercially available infant formula for healthy term infants

Other: Commercial Infant Formula

Human Milk

NO INTERVENTION

Breastfed infants serve as a reference group

Interventions

New Infant FormulaOTHER

New infant formula fed daily ad libitum

New Infant Formula
Commercial Infant FormulaOTHER

Commercially available infant formula fed daily ad libitum

Commercial Infant Formula

Eligibility Criteria

Age0 Days - 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ObvioHealth

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Parth Shah, MD FAPCR

    ObvioHealth

    PRINCIPAL INVESTIGATOR

  • Dawn Ross, Director Clinical Project Management

    IQVIA RDS Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A decentralized, randomized, controlled trial of healthy term breastfed and formula-fed infants for 16 weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 19, 2022

Study Start

September 21, 2022

Primary Completion

January 2, 2024

Study Completion

January 2, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)