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OpenTrials
Completed

NCT Number: NCT03488758

Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk formula compared to a cow milk formula

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Key information

Conditions

Feeding Behavior Behavior Behavior, Animal Bottle Feeding Feeding, Bottle

Age range

2 month–3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2 Avenue Camille Blanc,, Beausoleil, France

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About this study

This is a feasibility study to determine the utility of two new standardized psychometric tools for paediatricians to assess and manage feeding difficulties in formula fed infants. Baby Eating Behaviour Questionnaire (BEBQ) and Montreal Children's Hospital Feeding Scale (MCH-Feeding Scale) will be used in this study.

The secondary objectives are to determine if these tools can then measure the changes in behaviour after introducing two formula that differ in the sources of protein, ie formula made from whole goat milk compared to a conventional formula made from cow milk proteins. The quality of life and general health outcomes of these infants will also be monitored.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy infants aged 2-3 months, predominantly formula fed

Exclusion criteria

  • Infants born less than 37GA
  • Confirmed or suspected cow milk protein allergy
  • Predominantly breast fed
  • Infants suffering from chronic disease

Treatment and study plan

CMF

Other

Taking a infant formula based on cow milk protein fractions, 4-5 feeds per day given by bottle, 180-210 ml/feed, total 800-900ml per day for one mounth

GMF

Other

Taking a infant formula based on whole goat milk, 4-5 feeds per day given by bottle, 180-210 ml/feed, total 800-900ml per day for one mounth

Primary outcomes

  1. Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).

    Time frame: 1 month

    Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).

Secondary outcomes

  1. Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale

    Time frame: 1 month

    This feeding scale permit to distinguish babies with no feeding difficulties (score under 61) or with mild (61-65) , moderate (65-70), or severe feeding disorders (>70)

  2. Quality of life assessed by QUALIN

    Time frame: 1 month

    Quality of life assessed by QUALIN

  3. Formula liking, using 4-point visual analog scale (VAS)

    Time frame: 1 month

    Formula liking, using 4-point visual analog scale (VAS). The range of this scale goes from 0 (my baby hates this fomula) to 10 (my baby loves this formula)

  4. Incidences of rash

    Time frame: 1 month

    Incidences of rash

  5. Incidences of dry skin

    Time frame: 1 month

    Incidences of dry skin

  6. Incidences of eczema

    Time frame: 1 month

    Incidences of eczema

  7. Gastrointestinal symptoms

    Time frame: 1 month

    Gastrointestinal symptoms

  8. Weight

    Time frame: 1 month

  9. Height

    Time frame: 1 month

  10. head circomference

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: CHARLIE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2018
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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