Growth and Tolerance of Young Infants Fed Infant Formula

NCT04105686 | Completed

• 1 other identifier: AL31A
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 32

Brief Summary

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

Conditions

Growth and Tolerance

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight gain per day

  Day of life 14 to Day of life 119

Secondary Outcomes (4)

• Stool Characteristics

  Study Day 1 to Day of life 119

• Formula Tolerance

  Study Day 1 to Day of life 119

• Length

  Day of life 14 to Day of life 119

• Head Circumference (HC)

  Day of life 14 to Day of life 119

Other Outcomes (4)

• Infant and Household Characteristics

  Study Day 1 to Day of Life 119

• Infant Feeding and Stool Patterns Questionnaire

  Exit or Day of life 119

• Infant Behavior Questionnaire

  Exit or Day of life 42 to Day of life 119

Study Arms (3)

Control Infant Formula

ACTIVE COMPARATOR

Milk-based study product

Other: Control Infant Formula

Experimental Infant Formula

EXPERIMENTAL

Milk-based study product with oligosaccharides

Other: Experimental Infant Formula

Reference Group

NO INTERVENTION

Human milk-fed group

Interventions

Control Infant Formula OTHER

Ready to feed infant formula, feed ad libitum

Control Infant Formula

Experimental Infant Formula OTHER

Ready to feed infant formula, feed ad libitum

Experimental Infant Formula

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (32)

Central Research Associates

Birmingham, Alabama, 35205, United States

Location

Southeastern Pediatric Associates

Dothan, Alabama, 36305, United States

Location

Visions Clinical Research

Tucson, Arizona, 85712, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

TOPAZ Clinical Research, Inc.

Apopka, Florida, 32703, United States

Location

University Clinical Research-Deland, LLC dba Avail Clinical Research- West Volusia Pediatrics

DeLand, Florida, 32720, United States

Location

Children's Research, LLC

Lake Mary, Florida, 32746, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Pediatric & Adult Research Center

Orlando, Florida, 32825, United States

Location

Asclepes Research Centers

Spring Hill, Florida, 34609, United States

Location

Score Physician Alliance, LLC

St. Petersburg, Florida, 33710, United States

Location

PAS Research, LLC

Tampa, Florida, 33613, United States

Location

Tekton Research

Chamblee, Georgia, 30341, United States

Location

Saltzer Health

Nampa, Idaho, 83686, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47725, United States

Location

Springs Medical Research

Owensboro, Kentucky, 42303, United States

Location

Meridian Clinical Research 3080

Baton Rouge, Louisiana, 70806, United States

Location

Meridan Clinical Research

Omaha, Nebraska, 68134, United States

Location

Wake Research - Clinical Research Center of Nevada

Las Vegas, Nevada, 89123, United States

Location

ClinOhio Research Services

Columbus, Ohio, 43213, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45419, United States

Location

Institute of Clinical Research, LLC

Mentor, Ohio, 44060, United States

Location

The Cleveland Pediatric Research Center, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Midsouth Center for Clinical Research

Memphis, Tennessee, 38116, United States

Location

Medical Research Center of Memphis

Memphis, Tennessee, 38120, United States

Location

Gadolin Research, LLC

Beaumont, Texas, 77702, United States

Location

Women's Hospital at Renaissance - Doctors Hospital at Renaissance

Edinburg, Texas, 78539, United States

Location

Mercury Clincial Research, Inc.

Houston, Texas, 77008, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Aspen Clinical Research LLC

Orem, Utah, 84058, United States

Location

MultiCare Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Study Officials

• Timberly Williams, PhD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: September 30, 2019
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)