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OpenTrials
Completed

NCT Number: NCT03276884

Growth and Tolerance of Young Infants

To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.

Completed

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Key information

Conditions

Age range

Up to 8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Clinical Therapeutics, LLC, 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

  • Subject is judged to be in good health.
  • Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
  • Birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
  • Subject is between 0 and 8 days of age at enrollment.
  • 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 vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
  • Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.

Exclusion criteria

  • An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
  • Subject participates in another study that has not been approved as a concomitant study.

Treatment and study plan

Experimental Infant Formula

Other

amino acid-based infant formula powder

Control infant formula

Other

amino acid-based infant formula powder

Primary outcomes

  1. Weight Gain

    Time frame: Study Day 14 to Study Day 119

    Infant scale

Secondary outcomes

  1. GI tolerance

    Time frame: Study Day 1 to Study Day 119

    Parent completed questionnaires

  2. Length

    Time frame: Study Day 1 to Study Day 119

    Length board

  3. Head Circumference

    Time frame: Study Day 1 to Study Day 119

    Measure tape

  4. Weight

    Time frame: Study Day 1 to Study Day 119

    Infant scale

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Growth and Tolerance of Young Infants Fed Amino Acid-Based Formulas

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 8, 2017
Registry last updated
Dec 3, 2018

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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