Feeding Behavior, Feeding, Bottle
Conditions
Brief summary
To assess parental perceptions on infant feeding behavior and enjoyment with a goat milk formula compared to a cow milk formula
Detailed description
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.
Interventions
OTHERCMF
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
OTHERGMF
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
Sponsors
Centre Hospitalier Intercommunal Creteil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 3 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ). | 1 month | Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessed by QUALIN | 1 month | Quality of life assessed by QUALIN |
| Formula liking, using 4-point visual analog scale (VAS) | 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) |
| Incidences of rash | 1 month | Incidences of rash |
| Incidences of dry skin | 1 month | Incidences of dry skin |
| Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale | 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) |
| Gastrointestinal symptoms | 1 month | Gastrointestinal symptoms |
| Weight | 1 month | — |
| Height | 1 month | — |
| head circomference | 1 month | — |
| Incidences of eczema | 1 month | Incidences of eczema |
Countries
France
Outcome results
None listed