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Completed

NCT Number: NCT05047978

Growth and Tolerance of a Partially Hydrolyzed Infant Formula

The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.

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Key information

Conditions

Growth

Age range

10 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Pediatric Associates, Birmingham, Alabama, 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

  • 10 to 14 days of age at randomization
  • singleton birth
  • Gestational age of 37 to 42 weeks
  • Birth weight of 2500 g (5lbs 8oz or more)
  • Exclusively receiving infant formula for at least 24 hours prior to randomization
  • Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age
  • Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
  • Signed informed consent and authorization to use and disclose Protected Health information

Exclusion criteria

  • History of underlying metabolic or chronic disease
  • Evidence of feeding difficulties or history of formula intolerance
  • Weight at Visit 1 is <98% of birth weight
  • Infant was born large for gestational age from a mother who was diabetic at childbirth
  • Infant is immunocompromised

Treatment and study plan

Cow's milk protein infant formula

Other

A routine cow's milk-based infant formula

Partially hydrolyzed protein infant formula

Other

A partially hydrolyzed cow's milk protein (PHP) infant formula

Primary outcomes

  1. Rate of body weight gain

    Time frame: up to 120 days

Secondary outcomes

  1. Body length

    Time frame: up to 365 days of age

  2. Head circumference

    Time frame: up to 365 days of age

  3. Growth Z scores

    Time frame: up to 365 days of age

    weight-for-age

  4. Growth Z scores

    Time frame: up to 365 days of age

    length-for-age

  5. Growth Z scores

    Time frame: up to 365 days of age

    head circumference-for-age

  6. Recall of study formula intake measured at each study visit

    Time frame: up to 365 days of age

    questionnaire

  7. Recall of stool characteristics measured at each study visit

    Time frame: up to 365 days of age

    questionnaire

  8. Pediatric Quality of Life Family Impact Module

    Time frame: up to 365 days of age

    questionnaire

  9. Pediatric Quality of Life Inventory Infant Scales

    Time frame: 120, 180, 275, and 365 days of age

    Questionnaire. A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).

  10. Medically confirmed adverse events collected throughout the study period

    Time frame: up to 365 days of age

  11. Specific medically confirmed adverse events related to gastrointestinal

    Time frame: up to 365 days of age

  12. Specific medically confirmed adverse events related to allergy

    Time frame: up to 365 days of age

  13. Body weight

    Time frame: up to 365 days of age

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Official study title

Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 17, 2021
Registry last updated
Jan 23, 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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