Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age

Abbott Nutrition42 sites in 1 country607 target enrollmentJuly 21, 2021

ConditionsGrowth

Overview

Phase: N/A
Intervention: Not specified
Conditions: Growth
Sponsor: Abbott Nutrition
Enrollment: 607
Locations: 42
Primary Endpoint: Growth
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.

Registry

clinicaltrials.gov

Start Date

July 21, 2021

End Date

May 12, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participant is judged to be in good health as determined from participant's medical history
•Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks by parent report
•Participant's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
•Parent(s) confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life
•Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
•Parent(s) confirm their intention not to administer vitamin or mineral supplements,(except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study
•Parent(s) confirm their intention not to administer solid foods or juices to the infant from enrollment through 6 months of age unless recommended by the participant's HCP
•Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
•If parent(s) elect to feed the participant human milk, they confirm that their infant was fed human milk since birth and confirm their intention to exclusively feed human milk as the sole source of feeding through 6 months of age.
•If parent(s) of human milk fed participant elect to supplement or wean, they confirm their intention to use the experimental supplemental/weaning formula and experimental toddler drink as the primary milk beverage.

Exclusion Criteria

•An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
•Awareness of a positive drug screen (including but not limited to cocaine, heroin, or methamphetamine) in the mother or participant
•Suspected maternal substance abuse including alcohol
•Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
•Participant is in another study that has not been approved as a concomitant study by AN
•Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment
•Participant has been treated with other medications (besides antibiotics) that in the opinion of the PI may affect growth, GI tolerance and/or development, prior to enrollment

Outcomes

Primary Outcomes

Growth

Time Frame: Study Day 1 to 6 Months of Age

weight for age z-score

Secondary Outcomes

Length(Study Day 1 to 24 Months of Age)
Incidence of respiratory infection between study groups(Study Day 1 to 24 Months of Age)
Number of respiratory infection episodes between study groups(Study Day 1 to 24 Months of Age)
Incidence of infection morbidity between study groups(Study Day 1 to 24 Months of Age)
Number of episodes of infection morbidity between study groups(Study Day 1 to 24 Months of Age)
Weight(Study Day 1 to 24 Months of Age)
Head Circumference(Study Day 1 to 24 Months of Age)
Gastrointestinal Tolerance(Study Day 1 to 12 months of Age)