Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

Centre Hospitalier Intercommunal Creteil73 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Feeding Behavior Feeding, Bottle

Interventions

CMFOTHER

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

GMFOTHER

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

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 3 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (14)

2 Avenue Camille Blanc,

Beausoleil, France

20 avenue du général Sarail

Chatou, France

65 Avenue Henri Barbusse,

Le Blanc-Mesnil, France

Outcomes

Primary Outcomes

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

Time frame: 1 month

Secondary Outcomes

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)

Time frame: 1 month

Quality of life assessed by QUALIN

Time frame: 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)

Time frame: 1 month

Incidences of rash

Time frame: 1 month

Incidences of dry skin

Time frame: 1 month

Incidences of eczema

Time frame: 1 month

Gastrointestinal symptoms

Time frame: 1 month

Data from ClinicalTrials.gov

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