Infant Formula and Toddler Drink Feeding Intervention

Not Applicable

Terminated

• Conditions: Respiratory Infections in Children

• Registration Number: NCT04495738
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-03
• Study Start: 2020-08-10
• Primary Completion: 2021-04-12
• Study Completion: 2021-04-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of respiratory infection between study groups	Study Day 1 to 6 Months of Age	Adverse event reports

Secondary Outcome Measures

Name	Time	Method
Infection morbidity between study groups	Study Day 1 to 24 Months of Age	Adverse event reports

Trial Locations

Locations (27)

Southeastern Pediatric Associates; 🇺🇸 Dothan, Alabama, United States

Eclipse Clinical Research; 🇺🇸 Tucson, Arizona, United States

The Children's Clinic of Jonesboro, P.A.; 🇺🇸 Jonesboro, Arkansas, United States

Applied Research Center of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Boeson Research 3266; 🇺🇸 Grand Junction, Colorado, United States

TOPAZ Clinical Research, Inc.; 🇺🇸 Apopka, Florida, United States

ASCLEPES Research Centers; 🇺🇸 Spring Hill, Florida, United States

Meridian Clinical Research 3259; 🇺🇸 Macon, Georgia, United States

Clinical Research Prime; 🇺🇸 Idaho Falls, Idaho, United States

Leavitt Clinical Research; 🇺🇸 Idaho Falls, Idaho, United States

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