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

Abbott Nutrition27 sites in 1 country168 target enrollmentAugust 10, 2020

ConditionsRespiratory Infections in Children

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Respiratory Infections in Children
Sponsor: Abbott Nutrition
Enrollment: 168
Locations: 27
Primary Endpoint: Incidence of respiratory infection between study groups
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children fed a new infant formula and toddler drink through 24 months of age.

Registry

clinicaltrials.gov

Start Date

August 10, 2020

End Date

April 12, 2021

Last Updated

4 years 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
•Participant's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
•If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life
•If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
•If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age
•If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage
•Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study
•Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age
•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.

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
•Participant is taking and plans to continue medications (including over the counter (OTC), home remedies, 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
•Participant has been treated with antibiotics prior to enrollment