Infant Formula and Toddler Drink Feeding Intervention

Stopped early · Not applicable

Conditions studied: Respiratory Infections in Children

In brief

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.

Key facts

Study ID

NCT04495738

Run by

Abbott Nutrition

People needed

168

Starts

2020-08-10

Expected to finish

2021-04-12

Last updated by the study team

2021-05-14

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Qualmedica Research 3272 — Evansville, Indiana, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Qualmedica Research, LLC 3270 — Owensboro, Kentucky, United States
• Meridian Clinical Research 3080 — Baton Rouge, Louisiana, United States
• Boeson Research 3265 — Kalispell, Montana, United States
• Boeson Research 3267 — Missoula, Montana, United States
• Meridian Clinical Research 3264 — Grand Island, Nebraska, United States
• Meridian Clinical Research 3263 — Hastings, Nebraska, United States
• Ohio Pediatric Research Association — Dayton, Ohio, United States
• Cyn3rgy Research — Gresham, Oregon, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• MultiCare Institute for Research & Innovation — Dickinson, Texas, United States
• Maximos Ob/Gyn — League City, Texas, United States
• DCOL Center for Clinical Research — Longview, Texas, United States
• PAS Research 3273 — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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