Infant Formula and Toddler Drink Feeding Intervention
- Conditions
- Respiratory Infections in Children
- Interventions
- Other: Control Infant FormulaOther: Experimental Infant FormulaOther: Supplemental Formula for HM GroupOther: Toddler Drink for HM groupOther: Experimental Toddler DrinkOther: Control Toddler Drink
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 168
- 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.
- 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
- Arm && Interventions
Group Intervention Description Human Milk (HM) Reference Group Toddler Drink for HM group HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product Control Feeding Group Control Infant Formula Ready to feed milk-based product Experimental Feeding Group Experimental Infant Formula Ready to feed milk-based product with oligosaccharides Human Milk (HM) Reference Group Supplemental Formula for HM Group HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product Experimental Feeding Group Experimental Toddler Drink Ready to feed milk-based product with oligosaccharides Control Feeding Group Control Toddler Drink Ready to feed milk-based product
- 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)
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Southeastern Pediatric Associates
🇺🇸Dothan, Alabama, United States
MultiCare Institute for Research & Innovation
🇺🇸Dickinson, Texas, United States
Meridian Clinical Research 3263
🇺🇸Hastings, Nebraska, United States
TOPAZ Clinical Research, Inc.
🇺🇸Apopka, Florida, United States
Boeson Research 3267
🇺🇸Missoula, Montana, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Maximos Ob/Gyn
🇺🇸League City, Texas, United States
Mercury Clinical Research 3261
🇺🇸Tacoma, Washington, United States
Boeson Research 3265
🇺🇸Kalispell, Montana, United States
Ohio Pediatric Research Association
🇺🇸Dayton, Ohio, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Multicare Rockwood Pediatrics
🇺🇸Spokane, Washington, 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
ASCLEPES Research Centers
🇺🇸Spring Hill, Florida, United States
Meridian Clinical Research 3259
🇺🇸Macon, Georgia, 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
PAS Research 3273
🇺🇸McAllen, Texas, United States
Meridian Clinical Research 3264
🇺🇸Grand Island, Nebraska, United States