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CompletedNCT04006236Updated Sep 24, 2021

Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

An interventional study of Experimental Infant Formula and Control Infant Formula in Infant Development, sponsored by Abbott Nutrition. Completed at 17 sites in United States. Open to participants aged 0 Days to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by Abbott Nutrition · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
245
Allocation
Randomized
Ages
0 Days to 14 Days
Sex
All
01

Study summary

This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.

02

Conditions studied

  • Infant Development
03

In context

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 14 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Participant is judged to be in good health
  • 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) 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
  • Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization

Exclusion criteria

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, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
  • Participant participates in another study that has not been approved as a concomitant study by AN.
  • Participant has an allergy or intolerance to any ingredient in the study product
  • Participant has been treated with antibiotics within 1 week prior to enrollment
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
245 participants (actual)

Study arms

  • Experimental
    Experimental Infant Formula

    extensively hydrolyzed casein protein

    Other: Experimental Infant Formula

  • Active comparator
    Control Infant Formula

    extensively hydrolyzed casein protein

    Other: Control Infant Formula

Interventions

  • OtherExperimental Infant Formula

    Feed Ad Libitum

  • OtherControl Infant Formula

    Feed Ad Libitum

06

What researchers measure

Primary outcomes

  1. Weight

    Interval weight gain per day

    Time frame: Day of Age (DOA) 14 to 119

Secondary outcomes

  1. Length

    Interval length gain per day

    Time frame: Study Day (SD) 1 to DOA 119

  2. Head Circumference

    Interval HC gain per day

    Time frame: Study Day (SD) 1 to DOA 119

  3. Stool Characteristics

    Parent Completed Diary

    Time frame: Study Day (SD) 1 to DOA 119

  4. Formula Intake

    Parent Completed Diary

    Time frame: Study Day (SD) 1 to DOA 119

Other outcomes

  1. Infant Feeding and Stool Patterns Questionnaire

    Parent completed questionnaire; 16 questions with 5 categories scaled in the negative direction

    Time frame: Exit or DOA 119

  2. Infant Behavior Questionnaire

    Parent completed questionnaire; 22 questions with 5 categories scaled in the negative direction

    Time frame: Exit or DOA 119

  3. Formula Satisfaction Questionnaire

    Parent completed questionnaire; 13 questions of up to 5 categories scaled in the negative direction

    Time frame: Exit or DOA 119

07

Study locations

17 sites
  • MedPharmics, LLC
    Phoenix, Arizona 85015, United States
  • Watching Over Mothers & Babies
    Tucson, Arizona 85712, United States
  • Paramount Research Solutions
    College Park, Georgia 30349, United States
  • Springs Medical Research
    Owensboro, Kentucky 42303, United States
  • MedPharmics, LLC
    Metairie, Louisiana 70006, United States
  • MedPharmics, LLC
    Gulfport, Mississippi 30503, United States
  • Quality Clinical Research Inc
    Omaha, Nebraska 68114, United States
  • MedPharmics, LLC
    Albuquerque, New Mexico 87102, United States
  • PMG Research of Peidmont Healthcare
    Statesville, North Carolina 28625, United States
  • Pediatric Associates of Fairfield, Inc.
    Fairfield, Ohio 45014, United States
  • Institute of Clinical Research, LLC
    Mentor, Ohio 44060, United States
  • The Cleveland Pediatric Research Center, LLC
    Middleburg Heights, Ohio 44130, United States
  • Children's Hospital
    Sioux Falls, South Dakota 57105, United States
  • Midsouth Center for Clinical Research
    Memphis, Tennessee 38116, United States
  • Ventavia Research Group, Llc
    Fort Worth, Texas 76104, United States
  • Ventavia Research Group
    Houston, Texas 77008, United States
  • Ventavia Research Group, LLC
    Plano, Texas 75093, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04006236
Lead sponsor
Abbott Nutrition
Responsible party
Sponsor
First posted
Jul 5, 2019
Start date
Aug 5, 2019
Primary completion
Sep 20, 2021
Completion
Sep 20, 2021
Last update
Sep 24, 2021

Study contacts

Carlett Ramirez
study chair · Abbott Nutrition

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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