Growth and Tolerance of Infants Fed Infant Formulas

Growth and Tolerance of Young Infants Fed Infant Formulas

To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.

Study Overview

• Status: Completed
• Conditions: Growth and Tolerance
• Intervention / Treatment: Other: Human Milk; Other: Control Formula; Other: Experimental Formula 1; Other: Experimental Formula 2

• Study Type: Interventional
• Enrollment (Actual): 424
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • Guayama, Puerto Rico, 00784
    • Clinical Research Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine/ CAIMED Center
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics, LLC
    • Dothan, Alabama, United States, 36305
      • Alabama Clinical Therapeutics
  • Arizona
    • Tucson, Arizona, United States, 85712
      • W.O.M.B Watching Over Mothers and Babies
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Clinical Research Advantage/Colorado Springs Health Partners
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group, PC
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Atlantic Clinical Research Collaborative
    • Orange City, Florida, United States, 32763
      • Lake Mary Pediatrics
    • St. Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance, LLC
    • Tampa, Florida, United States, 33606
      • USF, College of Medicine, Dept of Pediatrics
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Southeast Regional Research Group (SERRG)
  • Indiana
    • Evansville, Indiana, United States, 47720
      • PediaResearch, LLC
    • Indianapolis, Indiana, United States, 46256
      • Northpoint Pediatrics, LLC
    • Lafayette, Indiana, United States, 47905
      • Lafayette Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln, PC
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Dayton, Ohio, United States, 45406
      • Dayton Clinical Research
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association, Inc
    • Mayfield Heights, Ohio, United States, 44124
      • Institute of Clinical Research
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Clinical Trials of America
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Red Lion Pediatrics
  • South Dakota
    • Sioux Falls, South Dakota, United States, 65104
      • Sanford Research
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Memorial Clinic
  • Washington
    • Spokane, Washington, United States, 99202
      • Rockwood Clinic, PS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Singleton from full term birth with a gestational age 37-42 weeks
• Birth weight > 2490 g (~5 lbs 8 oz)
• Between 0 and 5 days of age
• Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
• Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
• Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
• No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional

Exclusion Criteria:

• Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
• Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
• Treatment with antibiotics
• Mother intends to use a combination of breast and formula feeding

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Human Milk; Reference group, breast feeding ad libitum	Other: Human Milk; Feeding ad libitum; Other Names: Breast feeding group
Active Comparator: Control Formula; Ready to feed infant formula, feed ad libitum	Other: Control Formula; Feeding ad libitum; Other Names: Commercially available Infant Formula
Experimental: Experimental Formula 1; Ready to feed infant formula with human milk oligosaccharides, feed ad libitum	Other: Experimental Formula 1; Feeding ad libitum
Experimental: Experimental Formula 2; Ready to feed infant formula with human milk oligosaccharides, feed ad libitum	Other: Experimental Formula 2; Feeding ad libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight gain per day	Study Day (SD) 14 - 119

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool Characteristics	Stool consistency and number per day	Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Feeding Tolerance	% of feedings with spit up associated with feeding	Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Length	Length and interval length gain per day	Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Head Circumference	Head circumference (HC) and interval HC gain per day	Study Day (SD) 1, 14, 28, 42, 84 and 119 visits

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Formula Intake	Average volume of study formula intake and average number of study formula feedings per day	Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Oligosaccharides	Infant urine sample	Study Day (SD) 42 and 119 visits

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Publications and helpful links

General Publications

• Goehring KC, Marriage BJ, Oliver JS, Wilder JA, Barrett EG, Buck RH. Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2559-2566. doi: 10.3945/jn.116.236919. Epub 2016 Oct 26.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: March 7, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 2, 2014
• Last Update Submitted That Met QC Criteria: May 30, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: AL06