Growth and Tolerance of Young Infants

Growth and Tolerance of Young Infants Fed Amino Acid-Based Formulas

To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Watching Over Mothers and Babies
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro, P.A.
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group, PC
  • Florida
    • Lake Mary, Florida, United States, 32746
      • Children's Research, LLC
    • Saint Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance, LLC
  • Idaho
    • Nampa, Idaho, United States, 83686
      • Saltzer Medical Group
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic, Inc.
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Springs Medical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, PC
  • Ohio
    • Fairfield, Ohio, United States, 45014
      • Pediatric Associates of Fairfield, Inc.
    • Mentor, Ohio, United States, 44060
      • Institute of Clinical Research, LLC
    • Middleburg Heights, Ohio, United States, 44130
      • The Cleveland Pediatric Research Center, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Medical Research South
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research 3002
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Pediatric Associates 3004
    • North Charleston, South Carolina, United States, 29406
      • Coastal Pediatric Research 3003
  • Tennessee
    • Memphis, Tennessee, United States, 38116
      • Memphis & Shelby County Pediatric Group
  • Texas
    • Houston, Texas, United States, 77017
      • Vilo Research Group Inc
    • San Antonio, Texas, United States, 78229
      • Southwest Children's Research Associates, PA
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is judged to be in good health.
• Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
• Birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
• Subject is between 0 and 8 days of age at enrollment.
• Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
• Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.

Exclusion Criteria:

• An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
• Subject 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Infant Formula; Infant formula powder to be fed ad libitum	Other: Experimental Infant Formula; amino acid-based infant formula powder
Active Comparator: Control Infant Formula; Infant formula powder to be fed ad libitum	Other: Control Infant Formula; amino acid-based infant formula powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Gain	Infant scale	Study Day 14 to Study Day 119

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GI tolerance	Parent completed questionnaires	Study Day 1 to Study Day 119
Length	Length board	Study Day 1 to Study Day 119
Head Circumference	Measure tape	Study Day 1 to Study Day 119
Weight	Infant scale	Study Day 1 to Study Day 119

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Jan Kajzer, MS, RD, LD, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): November 8, 2018
• Study Completion (Actual): November 8, 2018

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AL23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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