Infant Formula and Toddler Drink Feeding Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Growth
• Intervention / Treatment: Other: Control Infant Formula; Other: Control Toddler Drink; Other: Experimental Infant Formula; Other: Experimental Toddler Drink; Other: Human Milk; Other: Human Milk Supplemental Formula; Other: Human Milk Toddler Drink

• Study Type: Interventional
• Enrollment (Actual): 637
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • MedPharmics, LLC 3192
  • Arkansas
    • Glenwood, Arkansas, United States, 71943
      • Healthstar Research
    • Hot Springs, Arkansas, United States, 71913
      • HealthStar Research, LLC
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro, P.A.
    • Little Rock, Arkansas, United States, 72019
      • Applied Research Center of Arkansas
  • Colorado
    • Colorado Springs, Colorado, United States, 80922
      • Optumcare Colorado Springs, LLC
    • Grand Junction, Colorado, United States, 81505
      • Boeson Research 3266
  • Florida
    • Apopka, Florida, United States, 32703
      • Topaz Clinical Research, Inc.
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services, LLC.
    • Panama City, Florida, United States, 32405
      • Emerald Coast OBGYN Clinical Research
    • Spring Hill, Florida, United States, 34609
      • Asclepes Research Centers
    • Tampa, Florida, United States, 33617
      • Jedidiah Clinical Research
  • Georgia
    • Macon, Georgia, United States, 31210
      • Meridian Clinical Research 3259
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt Clinical Research
  • Indiana
    • Evansville, Indiana, United States, 47725
      • Deaconess Clinic, Inc.
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Qualmedica Research, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
    • Covington, Louisiana, United States, 70433
      • MedPharmics, LLC 3343
    • Slidell, Louisiana, United States, 70458
      • MedPharmics Research 3369
  • Montana
    • Great Falls, Montana, United States, 59405
      • Boeson Research 3367
    • Kalispell, Montana, United States, 59901
      • Boeson Research 3265
    • Missoula, Montana, United States, 59804
      • Boeson Research 3267
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Meridian Clinical Research 3264
    • Hastings, Nebraska, United States, 68901
      • Meridian Clinical Research 3263
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research
    • Lincoln, Nebraska, United States, 68510
      • Meridian Clinical Research 3304
    • Omaha, Nebraska, United States, 68117
      • University of Nebraska Medical Center 3315
    • Omaha, Nebraska, United States, 68131
      • University of Nebraska Medical Center 3314
  • New York
    • Bronx, New York, United States, 10468
      • Advantage Clinical Trials
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research LLC 3313
    • Spartanburg, South Carolina, United States, 29301
      • Tribe Clinical Research LLC 3382
    • Summerville, South Carolina, United States, 29486
      • Coastal Pediatric Research
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group 3301
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group 3046
    • Memphis, Tennessee, United States, 38115
      • AVIATI Healthcare & Clinical Research
  • Texas
    • Dallas, Texas, United States, 75230
      • Javara Inc. 3377
    • League City, Texas, United States, 77573
      • Maximos Ob/Gyn
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research, Inc
  • Washington
    • Spokane, Washington, United States, 99202
      • Multicare Health System - Rockwood Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Feeding Group; Milk based product	Other: Control Infant Formula; Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age; Other: Control Toddler Drink; ~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Experimental: Experimental Feeding Group; Milk based product with oligosaccharides	Other: Experimental Infant Formula; Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age; Other: Experimental Toddler Drink; ~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
Other: Human Milk Reference Group; Human Milk	Other: Human Milk; Ad libitum or as instructed by HCP; Other: Human Milk Supplemental Formula; Ad libitum if consuming supplemented formula; feeding period up to 12 months of age; Other: Human Milk Toddler Drink; ~16 fl oz per day if providing supplemental nutrition other than HM; feeding period from 12 to 24 months of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	weight for age z-score	Study Day 1 to 6 Months of Age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of respiratory infection between study groups	Adverse event reports	Study Day 1 to 24 Months of Age
Number of respiratory infection episodes between study groups	Adverse event reports	Study Day 1 to 24 Months of Age
Incidence of infection morbidity between study groups	Adverse event reports	Study Day 1 to 24 Months of Age
Number of episodes of infection morbidity between study groups	Adverse event reports	Study Day 1 to 24 Months of Age
Weight	Interval weight gain per day	Study Day 1 to 24 Months of Age
Length	Interval length gain per day	Study Day 1 to 24 Months of Age
Head Circumference	Interval head circumference gain per day	Study Day 1 to 24 Months of Age
Gastrointestinal Tolerance	Parent completed diary	Study Day 1 to 12 months of Age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula Satisfaction Questionnaire	Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative	28 Days of Age to 6 Months of Age
Toddler Drink Satisfaction Questionnaire	Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled from positive to negative	18 Months of Age to 24 Months of Age
Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from Always to Never	28 Days of Age to 119 Days of Age]
Infant and Toddler Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled from Always to Never	119 Days of Age
Product Intake	Parent completed intake diary	Study Day 1 to 24 Months of Age
Dietary Intake	Parent completed 24-hour recall	6 Months of Age to 24 Months of Age
Stool Sample	Microbiota characterization; Subset of subjects	Study Day 1 to 24 Months of Age
Bayley™-4 Scale of Infant & Toddler Development IV	Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups; Subset of subjects	12 Months of Age to 24 Months of Age
MacArthur Communicative Developmental Inventory (CDI)/Words and Gestures and CDI)/Words and Sentences	Parent completed questionnaire of Words and Gestures and Words and Sentences; Percentiles compared to normative group data and between groups	12 Months of Age to 24 Months of Age
Modified Home Short Form	Parent completed questionnaire; 8 questions related to the home environment adapted from the HSF compared between groups	6 Months of Age to 24 Months of Age]
Medications	Medication usage including frequency and reason for use	Study Day 1 to 24 Months of Age
Adverse Events	Parent reported adverse events	Study Day 1 to 24 Months of Age
Health Resource Utilization	Number of visits	Study Day 1 to 24 Months of Age
Missed Parental Work Days	Parent reported number of days	Study Day 1 to 24 Months of Age
Blood Collection	Blood Immune Markers; Subset of subjects	6 and 24 Months of Age

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Bridget Barrett Reis, PhD, RD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AL51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No