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Completed

NCT Number: NCT04006236

Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

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.

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Key information

Conditions

Age range

0 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedPharmics, LLC, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Experimental Infant Formula

Other

Feed Ad Libitum

Control infant formula

Other

Feed Ad Libitum

Primary outcomes

  1. Weight

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

    Interval weight gain per day

Secondary outcomes

  1. Length

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

    Interval length gain per day

  2. Head Circumference

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

    Interval HC gain per day

  3. Stool Characteristics

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

    Parent Completed Diary

  4. Formula Intake

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

    Parent Completed Diary

Other outcomes

  1. Infant Feeding and Stool Patterns Questionnaire

    Time frame: Exit or DOA 119

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

  2. Infant Behavior Questionnaire

    Time frame: Exit or DOA 119

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

  3. Formula Satisfaction Questionnaire

    Time frame: Exit or DOA 119

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

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Growth and Tolerance of Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 5, 2019
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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