Growth and Tolerance of Young Infants Fed Infant Formula

Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides

This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.

Study Overview

• Status: Completed
• Conditions: Growth and Tolerance
• Intervention / Treatment: Other: Control Infant Formula; Other: Experimental Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
  • Florida
    • Apopka, Florida, United States, 32703
      • Topaz Clinical Research, Inc.
    • DeLand, Florida, United States, 32720
      • University Clinical Research-Deland, LLC dba Avail Clinical Research- West Volusia Pediatrics
    • Lake Mary, Florida, United States, 32746
      • Children's Research, LLC
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Orlando, Florida, United States, 32825
      • Pediatric & Adult Research Center
    • Saint Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance, LLC
    • Spring Hill, Florida, United States, 34609
      • Asclepes Research Centers
    • Tampa, Florida, United States, 33613
      • PAS Research, LLC
  • Georgia
    • Chamblee, Georgia, United States, 30341
      • Tekton Research
  • Idaho
    • Nampa, Idaho, United States, 83686
      • Saltzer Health
  • Indiana
    • Evansville, Indiana, United States, 47725
      • Deaconess Clinic, Inc.
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Meridian Clinical Research 3080
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridan Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Wake Research - Clinical Research Center of Nevada
  • Ohio
    • Columbus, Ohio, United States, 43213
      • ClinOhio Research Services
    • Dayton, Ohio, United States, 45419
      • PriMed Clinical Research
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
    • Mentor, Ohio, United States, 44060
      • Institute of Clinical Research, LLC
    • Middleburg Heights, Ohio, United States, 44130
      • The Cleveland Pediatric Research Center, LLC
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Medical Research Center of Memphis
    • Memphis, Tennessee, United States, 38116
      • Midsouth Center for Clinical Research
  • Texas
    • Beaumont, Texas, United States, 77702
      • Gadolin Research, LLC
    • Edinburg, Texas, United States, 78539
      • Women's Hospital at Renaissance - Doctors Hospital at Renaissance
    • Houston, Texas, United States, 77008
      • Mercury Clincial Research, Inc.
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
  • Utah
    • Orem, Utah, United States, 84058
      • Aspen Clinical Research LLC
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• 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.).
• Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
• Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
• Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
• Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
• Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or 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 taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
• Participant participates in another study that has not been approved as a concomitant study.

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 Infant Formula; Milk-based study product	Other: Control Infant Formula; Ready to feed infant formula, feed ad libitum
Experimental: Experimental Infant Formula; Milk-based study product with oligosaccharides	Other: Experimental Infant Formula; Ready to feed infant formula, feed ad libitum
No Intervention: Reference Group; Human milk-fed group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight gain per day	Day of life 14 to Day of life 119

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Characteristics	Parent completed diary	Study Day 1 to Day of life 119
Formula Tolerance	Parent completed diary	Study Day 1 to Day of life 119
Length	Length gain per day	Day of life 14 to Day of life 119
Head Circumference (HC)	HC gain per day	Day of life 14 to Day of life 119

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant and Household Characteristics	Parent reported lifestyle and illness questions	Study Day 1 to Day of Life 119
Infant Feeding and Stool Patterns Questionnaire	Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction	Exit or Day of life 119
Infant Behavior Questionnaire	Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction	Exit or Day of life 42 to Day of life 119
Formula Satisfaction Questionnaire	Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction	Exit or Day of life 119

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): December 4, 2020
• Study Completion (Actual): December 4, 2020

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AL31A

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