Infant Formula and Toddler Drink Feeding Study

Last updated: April 23, 2025
Sponsor: Abbott Nutrition
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Human Milk

Control Toddler Drink

Experimental Infant Formula

Clinical Study ID

NCT04957992
AL51
  • Ages < 14
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is judged to be in good health as determined from participant's medicalhistory

  • Participant is a singleton from a full-term birth with a gestational age of 37 - 42weeks by parent report

  • Participant's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)

  • Parent(s) confirm their intention to feed their infant the study product as the solesource of feeding from Study Visit 1 to 6 months of age, and as the sole milkbeverage during the first 12 months of life

  • Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage

  • Parent(s) confirm their intention not to administer vitamin or mineralsupplements,(except for vitamin D supplements if instructed by their healthcareprofessional) from enrollment through the duration of the study

  • Parent(s) confirm their intention not to administer solid foods or juices to theinfant from enrollment through 6 months of age unless recommended by theparticipant's HCP

  • 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 inthe study

  • If parent(s) elect to feed the participant human milk, they confirm that theirinfant was fed human milk since birth and confirm their intention to exclusivelyfeed human milk as the sole source of feeding through 6 months of age.

  • If parent(s) of human milk fed participant elect to supplement or wean, they confirmtheir intention to use the experimental supplemental/weaning formula andexperimental toddler drink as the primary milk beverage.

Exclusion

Exclusion Criteria:

  • An adverse maternal, fetal or participant medical history that is thought by theinvestigator to have potential for effects on tolerance, growth, and/or development

  • Awareness of a positive drug screen (including but not limited to cocaine, heroin,or methamphetamine) in the mother or participant

  • Suspected maternal substance abuse including alcohol

  • Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation),herbal preparations, prebiotics or probiotics, or rehydration fluids that mightaffect GI tolerance

  • Participant is in another study that has not been approved as a concomitant study byAN

  • Participant has been treated with antibiotics (except for topical antibiotics, eyedrops) prior to enrollment

  • Participant has been treated with other medications (besides antibiotics) that inthe opinion of the PI may affect growth, GI tolerance and/or development, prior toenrollment

Study Design

Total Participants: 607
Treatment Group(s): 7
Primary Treatment: Human Milk
Phase:
Study Start date:
July 21, 2021
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • MedPharmics, LLC 3192

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • HealthStar Research

    Glenwood, Arkansas 71943
    United States

    Site Not Available

  • HealthStar Research, LLC

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • The Children's Clinic of Jonesboro, P.A.

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • Applied Research Center of Arkansas

    Little Rock, Arkansas 72019
    United States

    Site Not Available

  • Optumcare Colorado Springs, LLC

    Colorado Springs, Colorado 80922
    United States

    Site Not Available

  • Boeson Research 3266

    Grand Junction, Colorado 81505
    United States

    Site Not Available

  • TOPAZ Clinical Research, Inc.

    Apopka, Florida 32703
    United States

    Site Not Available

  • Kissimmee Clinical Research

    Kissimmee, Florida 34743
    United States

    Site Not Available

  • Columbus Clinical Services, LLC.

    Miami, Florida 33125
    United States

    Site Not Available

  • Health and Life Research Institute

    Miami, Florida 33155
    United States

    Site Not Available

  • Emerald Coast OBGYN Clinical Research

    Panama City, Florida 32405
    United States

    Site Not Available

  • Pensacola Research Consultations Inc.

    Pensacola, Florida 32503
    United States

    Site Not Available

  • ASCLEPES Research Centers

    Spring Hill, Florida 34609
    United States

    Site Not Available

  • Jedidiah Clinical Research

    Tampa, Florida 33617
    United States

    Site Not Available

  • Meridian Clincial Research 3259

    Macon, Georgia 31210
    United States

    Active - Recruiting

  • Meridian Clinical Research 3259

    Macon, Georgia 31210
    United States

    Site Not Available

  • Clinical Research Prime

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Leavitt Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Deaconess Clinic, Inc.

    Evansville, Indiana 47725
    United States

    Site Not Available

  • Qualmedica Research

    Evansville, Indiana 47715
    United States

    Site Not Available

  • Qualmedica Research, LLC

    Owensboro, Kentucky 42301
    United States

    Site Not Available

  • Meridian Clinical Research 3080

    Baton Rouge, Louisiana 70806
    United States

    Site Not Available

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • MedPharmics, LLC 3343

    Covington, Louisiana 70433
    United States

    Site Not Available

  • MedPharmics, LLC 3081

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • MedPharmics Research 3369

    Slidell, Louisiana 70458
    United States

    Site Not Available

  • Southern Clinical Research

    Zachary, Louisiana 70791
    United States

    Site Not Available

  • Boeson Research 3367

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Boeson Research 3265

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Boeson Research 3267

    Missoula, Montana 59804
    United States

    Site Not Available

  • Meridian Clincial Research 3264

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Meridian Clinical Research 3264

    Grand Island, Nebraska 68803
    United States

    Site Not Available

  • Meridian Clinical Research 3263

    Hastings, Nebraska 68901
    United States

    Site Not Available

  • Alivation Research

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • Meridian Clinical Research 3304

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • University of Nebraska Medical Center 3314

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • University of Nebraska Medical Center 3315

    Omaha, Nebraska 68117
    United States

    Site Not Available

  • Med Clinical Research Partners, LLC

    Irvington, New Jersey 07111
    United States

    Site Not Available

  • Advantage Clincial Trials

    Bronx, New York 10468
    United States

    Site Not Available

  • Advantage Clinical Trials

    Bronx, New York 10468
    United States

    Site Not Available

  • Ohio Pediatric Research Association

    Dayton, Ohio 45414
    United States

    Site Not Available

  • Tribe Clinical Research LLC 3313

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Tribe Clinical Research LLC 3382

    Spartanburg, South Carolina 29301
    United States

    Site Not Available

  • Coastal Pediatric Research

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Holston Medical Group 3301

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Holston Medical Group 3046

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • AVIATI Healthcare & Clinical Research

    Memphis, Tennessee 38115
    United States

    Site Not Available

  • Javara Inc. 3377

    Dallas, Texas 75230
    United States

    Site Not Available

  • Maximos Ob/Gyn

    League City, Texas 77573
    United States

    Site Not Available

  • AIH Research

    Pearland, Texas 77584
    United States

    Site Not Available

  • National Clinical Research, Inc

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Multicare Health System - Rockwood Pediatrics

    Spokane, Washington 99202
    United States

    Site Not Available

  • Multicare Health System- Rockwood Pediatrics

    Spokane, Washington 99202
    United States

    Terminated

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