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Completed

NCT Number: NCT04389606

Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.

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Key information

Conditions

Healthy Term Infants

Age range

16 week–19 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Clinical Therapeutics, 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

  • Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Exclusion criteria

  • Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Treatment and study plan

Study Formula (SF)

Other

New infant formula for term infants fed ad lib

Comparator Formula (CF)

Other

Commercially available infant formula for term infants fed ad lib

Primary outcomes

  1. Weight Gain Velocity

    Time frame: up to 24 weeks

    G/D

Secondary outcomes

  1. Weight Measures

    Time frame: 20 weeks, 24 weeks

    KG

  2. Length Measures

    Time frame: 20 weeks, 24 weeks

    CM

  3. Length Gain Velocity

    Time frame: 20 weeks, 24 weeks

    CM/D

  4. Head Circumference Measures

    Time frame: 20 weeks, 24 weeks

    CM

  5. Weight for age Z-scores

    Time frame: 20 weeks, 24 weeks

    Weight for age Z-scores compared to World Health Organization (WHO) growth standards

  6. Length for age Z-scores

    Time frame: 20 weeks, 24 weeks

    Length for age Z-scores compared to WHO growth standards

  7. Head circumference for age Z-scores

    Time frame: 20 weeks, 24 weeks

    Head circumference for age Z-scores compared to WHO growth standards

  8. Weight for length Z-scores

    Time frame: 20 weeks, 24 weeks

    Weight for length Z-scores compared to WHO growth standards

  9. 72-hr record of formula intake at each study visit

    Time frame: 20 weeks, 24 weeks

    oz/d

  10. Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)

    Time frame: 24 weeks

    Concentration

  11. Blood concentrations of amino acids (umol/L)

    Time frame: 24 weeks

    Concentration

  12. Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals

    Time frame: 24 weeks

    Concentration

  13. Medically-diagnosed adverse events collected throughout the study period

    Time frame: 16-24 weeks

    Frequency

  14. Parent rating of infant stool consistency at each study visit

    Time frame: 20 weeks, 24 weeks

    Mean. Quinlan et al Likert scale; 0=no bowel movement, 1=hard [dry hard pellets], 2=formed [definite shape, not dry], 3=soft [no definite shape, pasty], 4=loose [no shape, some water], 5=watery [no shape, mainly water]).

  15. Parent report of infant stool frequency at each study visit

    Time frame: 20 weeks, 24 weeks

    Mean

  16. Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit

    Time frame: 20 weeks, 24 weeks

    Mean

  17. Stool microbiome

    Time frame: 24 weeks

    Fecal microbial taxa and community abundance

  18. Stool metabolome

    Time frame: 24 weeks

    Targeted and Untargeted Metabolomics

Sponsors and collaborators

Lead sponsor

ByHeart

Industry

Collaborators

  • Paidion Research, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 15, 2020
Registry last updated
Jul 21, 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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