Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein

Not Applicable

Completed

• Conditions: Feeding, Bottle; Feeding Behavior
• Interventions: Other: CMF; Other: GMF

• Registration Number: NCT03488758
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Study Timeline

• Study First Submitted: 2018-03-28
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-05
• Study Start: 2018-06-01
• Status Verified: 2021-12
• Primary Completion: 2021-12-05
• Study Completion: 2021-12-05
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CMF	CMF	infant formula based on cow milk protein fractions
GMF	GMF	infant formula based on whole goat milk

Primary Outcome Measures

Name	Time	Method
Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).	1 month	Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).

Secondary Outcome Measures

Name	Time	Method
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)
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
Incidences of eczema	1 month	Incidences of eczema
Gastrointestinal symptoms	1 month	Gastrointestinal symptoms
Weight	1 month
Height	1 month
head circomference	1 month

Trial Locations

Locations (14)

67 Rue Condorcet; 🇫🇷 Paris, France

92 Avenue de la République; 🇫🇷 Paris, France

CHU Robert Debré, 48 Bd Sérurier; 🇫🇷 Paris, France

13 Villa Beauséjour; 🇫🇷 Vincennes, France

20 avenue du général Sarail; 🇫🇷 Chatou, France

65 Avenue Henri Barbusse,; 🇫🇷 Le Blanc-Mesnil, France

67 Rue Condorcet,; 🇫🇷 Paris, France

2 Avenue Camille Blanc,; 🇫🇷 Beausoleil, France

41 Rue Aristide Briand,; 🇫🇷 Levallois-Perret, France

53 Boulevard De La Liberté; 🇫🇷 Les Lilas, France

157 Avenue du Général Leclerc; 🇫🇷 Maisons-Alfort, France

169 Avenue Achille Peretti; 🇫🇷 Neuilly-sur-Seine, France

3 Allée du 8 Mai 1945,; 🇫🇷 Suresnes, France

4 Rue Edouard Quenu; 🇫🇷 Paris, France