Infant Formula and Toddler Drink Feeding Intervention

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

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Infections in Children
• Intervention / Treatment: Other: Control Infant Formula; Other: Experimental Infant Formula; Other: Control Toddler Drink; Other: Experimental Toddler Drink; Other: Supplemental Formula for HM Group; Other: Toddler Drink for HM group

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates
  • Arizona
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research
  • Arkansas
    • 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
    • Grand Junction, Colorado, United States, 81505
      • Boeson Research 3266
  • Florida
    • Apopka, Florida, United States, 32703
      • Topaz Clinical Research, Inc.
    • Spring Hill, Florida, United States, 34609
      • Asclepes Research Centers
  • 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, 47715
      • Qualmedica Research 3272
    • Evansville, Indiana, United States, 47725
      • Deaconess Clinic, Inc.
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Qualmedica Research, LLC 3270
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Meridian Clinical Research 3080
  • Montana
    • 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
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Dickinson, Texas, United States, 77539
      • MultiCare Institute for Research & Innovation
    • League City, Texas, United States, 77573
      • Maximos Ob/Gyn
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
    • McAllen, Texas, United States, 78501
      • PAS Research 3273
  • Washington
    • Spokane, Washington, United States, 99202
      • Multicare Rockwood Pediatrics
    • Tacoma, Washington, United States, 98405
      • Mercury Clinical Research 3261

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• 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 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; Ready to feed 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; Ready to feed 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 (HM) Reference Group; HM from infant's own mother and as needed supplemental infant formula and toddler milk-based product	Other: Supplemental Formula for HM Group; Ad libitum formula given up to 12 months of age if HM is supplemented; Other: Toddler Drink for HM group; 16 fl oz per day if weaned from HM feedings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of respiratory infection between study groups	Adverse event reports	Study Day 1 to 6 Months of Age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection morbidity between study groups	Adverse event reports	Study Day 1 to 24 Months of Age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medications	Medication usage including frequency and reason for use	Study Day 1 to 24 Months of Age
Health Resource Utilization	Number of visits	Study Day 1 to 24 Months of Age
Weight	Weight in grams	Study Day 1 to 24 Months of Age
Length	Length in cm	Study Day 1 to 24 Months of Age
Head Circumference (HC)	HC in cm	Study Day 1 to 24 Months of Age
Gastrointestinal Tolerance	Parent completed diary	Study Day 1 to 119 Days of Age
Dietary Intake	Parent completed diary	Study Day 1 to 24 Months of Age
Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction	28 Days of Age to 119 Days of Age
Infant Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction	119 Days of Age
Formula Satisfaction Questionnaire	Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction	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 in the negative direction	15 Months of Age to 24 Months of Age
Human Milk Sample	Oligosaccharide characterization	84 Days of Age
Stool Sample	Microbiota characterization	Study Day 1 to 24 Months of Age
Saliva Sample	Maternal-Infant secretor status	84 Days 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
Behavioral Questionnaire	Parent completed questionnaire; 8 questions related to sleep, physical activity and screen time	12 Months of Age to 24 Months of Age
Ages & Stages Questionnaire	Parent completed questionnaire; 5 Developmental areas; Scores to the six questions in each area are totaled; Higher scores indicate more positive outcomes	6 Months of Age to 18 Months of Age
Bayley Scale of Infant & Toddler Development	Examiner rated assessment; Scores are totaled and compared to normative age group data and between groups	12 Months of Age to 24 Months of Age
MacArthur Communicative Developmental Inventory	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
Edinburgh Postnatal Depression Scale	Mother completed questionnaire; Scores for each of the 10 items are totaled; Higher scores indicate more depressive symptoms	28 Days of Age
Adverse Events	Standard Adverse Event reporting	Study Day 1 to 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): August 10, 2020
• Primary Completion (Actual): April 12, 2021
• Study Completion (Actual): April 12, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: AL38

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