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Completed

NCT Number: NCT05369494

Infants Fed a Hydrolyzed Infant Formula

The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.

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Key information

Conditions

Gastrointestinal Tolerance

Age range

0 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meridian Clinical Research, LLC, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infant is 0 to 90 days of age at enrollment.
  • Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
  • Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
  • 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 solid foods or juices to their infant from enrollment through the duration of the study
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
  • Infant's parent(s) or a LAR 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 prior to any participation in the study

Exclusion criteria

  • An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development
  • Awareness of a positive drug screen in the mother or participant
  • Suspected maternal substance abuse including alcohol
  • Participation in another study that has not been approved as a concomitant study by AN
  • Participant is receiving oral or inhaled steroids
  • Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
  • Participant has received an amino acid-based formula

Treatment and study plan

Hydrolyzed protein infant formula with oligosaccharides

Other

Hydrolyzed protein infant formula with oligosaccharides

Primary outcomes

  1. Weight Maintenance

    Time frame: Study Day1 to Study Day 28

    Change in weight for age z-score

Secondary outcomes

  1. Gastrointestinal Tolerance

    Time frame: Study Day1 to Study Day 28

    Parent completed diary

  2. Weight

    Time frame: Study Day1 to Study Day 28

    Weight gain per day in grams

  3. Length

    Time frame: Study Day1 to Study Day 28

    Length gain per day in cm

Other outcomes

  1. Parent Perspectives Questionnaire

    Time frame: Study Day1 to Study Day 28

    Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive with higher scores indicating better perception

  2. Formula Satisfaction Questionnaire

    Time frame: Study Day1 to Study Day 28

    Parent completed questionnaire; 13 questions of up to 5 categories, scaled from positive to negative

  3. Infant Feeding and Stool Patterns Questionnaire

    Time frame: Study Day1 to Study Day 28

    Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from always to never

  4. Health Care Utilization

    Time frame: Study Day1 to Study Day 28

    Number of Visits

  5. Adverse Events

    Time frame: Study Day1 to Study Day 28

    Parent reported adverse events

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Tolerance of Infants Fed a Hydrolyzed Infant Formula

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 11, 2022
Registry last updated
May 1, 2024

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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