Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

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

Detailed Description
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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.

Official Title
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Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

Conditions
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Feeding Behavior, Feeding, Bottle

Intervention / Treatment
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* Other: CMF
* Other: GMF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CMF<br>infant formula based on cow milk protein fractions | Other: CMF<br>* 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<br>|
| Experimental: GMF<br>infant formula based on whole goat milk | Other: GMF<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ). | Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale | 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) | 1 month | 
| Quality of life assessed by QUALIN | Quality of life assessed by QUALIN | 1 month | 
| Formula liking, using 4-point visual analog scale (VAS) | 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) | 1 month | 
| Incidences of rash | Incidences of rash | 1 month | 
| Incidences of dry skin | Incidences of dry skin | 1 month | 
| Incidences of eczema | Incidences of eczema | 1 month | 
| Gastrointestinal symptoms | Gastrointestinal symptoms | 1 month | 
| Weight |  | 1 month | 
| Height |  | 1 month | 
| head circomference |  | 1 month |