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Completed

NCT Number: NCT04105686

Growth and Tolerance of Young Infants Fed Infant Formula

This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.

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Key information

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Research Associates, Birmingham, Alabama, United States

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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 as determined from participant's medical history.
  • 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) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
  • Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
  • Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
  • Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
  • Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or 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 tolerance, growth, and/or development.
  • Participant is taking and plans to continue taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
  • Participant participates in another study that has not been approved as a concomitant study.

Treatment and study plan

Control infant formula

Other

Ready to feed infant formula, feed ad libitum

Experimental Infant Formula

Other

Ready to feed infant formula, feed ad libitum

Primary outcomes

  1. Weight

    Time frame: Day of life 14 to Day of life 119

    Weight gain per day

Secondary outcomes

  1. Stool Characteristics

    Time frame: Study Day 1 to Day of life 119

    Parent completed diary

  2. Formula Tolerance

    Time frame: Study Day 1 to Day of life 119

    Parent completed diary

  3. Length

    Time frame: Day of life 14 to Day of life 119

    Length gain per day

  4. Head Circumference (HC)

    Time frame: Day of life 14 to Day of life 119

    HC gain per day

Other outcomes

  1. Infant and Household Characteristics

    Time frame: Study Day 1 to Day of Life 119

    Parent reported lifestyle and illness questions

  2. Infant Feeding and Stool Patterns Questionnaire

    Time frame: Exit or Day of life 119

    Parent completed questionnaire; 16, 5-point Likert scale questions, scaled in the negative direction

  3. Infant Behavior Questionnaire

    Time frame: Exit or Day of life 42 to Day of life 119

    Parent completed questionnaire; 22 questions with 5-point Likert scale questions, scaled in the negative direction

  4. Formula Satisfaction Questionnaire

    Time frame: Exit or Day of life 119

    Parent completed questionnaire; 12 questions with 5-point Likert scale questions scaled in the negative direction

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2019
Registry last updated
Jan 25, 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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