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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	4 January 2022
Main ID:	NCT03488758
Date of registration:	28/03/2018
Prospective Registration:	Yes
Primary sponsor:	Centre Hospitalier Intercommunal Creteil
Public title:	Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein CHARLIE
Scientific title:	Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein
Date of first enrolment:	June 1, 2018
Target sample size:	73
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03488758
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
Phase:	N/A

Countries of recruitment
France

Contacts

Key inclusion & exclusion criteria

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

Age minimum: 2 Months
Age maximum: 3 Months
Gender: All

Health Condition(s) or Problem(s) studied

Feeding, Bottle

Feeding Behavior

Intervention(s)

Other: GMF

Other: CMF

Primary Outcome(s)

Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ). [Time Frame: 1 month]

Secondary Outcome(s)

Formula liking, using 4-point visual analog scale (VAS) [Time Frame: 1 month]

Height [Time Frame: 1 month]

Incidences of dry skin [Time Frame: 1 month]

Incidences of eczema [Time Frame: 1 month]

head circomference [Time Frame: 1 month]

Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale [Time Frame: 1 month]

Gastrointestinal symptoms [Time Frame: 1 month]

Incidences of rash [Time Frame: 1 month]

Quality of life assessed by QUALIN [Time Frame: 1 month]

Weight [Time Frame: 1 month]

Secondary ID(s)

CHARLIE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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