Clinical trial NCT03488758: Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein
Official title: Enjoyment of Infant Formulas Based on Cow or Goat Milk Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Feeding, Bottle
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 73
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Feeding enjoyment score from Baby Eating Behaviour Questionnaire (BEBQ).
timeFrame: 1 month
Secondary outcomes:
measure: Feeding behaviour assessed by Montreal Children's Hospital Feeding Scale
timeFrame: 1 month
measure: Quality of life assessed by QUALIN
timeFrame: 1 month
measure: Formula liking, using 4-point visual analog scale (VAS)
timeFrame: 1 month
measure: Incidences of rash
timeFrame: 1 month
measure: Incidences of dry skin
timeFrame: 1 month
measure: Incidences of eczema
timeFrame: 1 month
measure: Gastrointestinal symptoms
timeFrame: 1 month
measure: Weight
timeFrame: 1 month
measure: Height
timeFrame: 1 month
measure: head circomference
timeFrame: 1 month
Other outcomes:
Locations:
city: Beausoleil
country: France
facility: 2 Avenue Camille Blanc,
city: Chatou
country: France
facility: 20 avenue du général Sarail
city: Le Blanc-Mesnil
country: France
facility: 65 Avenue Henri Barbusse,
city: Les Lilas
country: France
facility: 53 Boulevard De La Liberté
city: Levallois-Perret
country: France
facility: 41 Rue Aristide Briand,
city: Maisons-Alfort
country: France
facility: 157 Avenue du Général Leclerc
city: Neuilly-sur-Seine
country: France
facility: 169 Avenue Achille Peretti
city: Paris
country: France
facility: 4 Rue Edouard Quenu
city: Paris
country: France
facility: 67 Rue Condorcet,
city: Paris
country: France
facility: 67 Rue Condorcet
city: Paris
country: France
facility: 92 Avenue de la République
city: Paris
country: France
facility: CHU Robert Debré, 48 Bd Sérurier
city: Suresnes
country: France
facility: 3 Allée du 8 Mai 1945,
city: Vincennes
country: France
facility: 13 Villa Beauséjour
Study officials:
References:
citation: Ambrosoli R, Di Stasio L, Mazzocco P. Content of alpha S1-casein and coagulation properties in goat milk. J Dairy Sci. 1988 Jan;71(1):24-8. doi: 10.3168/jds.S0022-0302(88)79520-X.
citation: Bates JE, Freeland CA, Lounsbury ML. Measurement of infant difficultness. Child Dev. 1979 Sep;50(3):794-803.
citation: Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.
citation: Forsyth BW, McCarthy PL, Leventhal JM. Problems of early infancy, formula changes, and mothers' beliefs about their infants. J Pediatr. 1985 Jun;106(6):1012-7. doi: 10.1016/s0022-3476(85)80260-2.
citation: Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2.
citation: Infante DD, Segarra OO, Redecillas SS, Alvarez MM, Miserachs MM. Modification of stool's water content in constipated infants: management with an adapted infant formula. Nutr J. 2011 May 19;10:55. doi: 10.1186/1475-2891-10-55.
citation: Kunz C, Lonnerdal B. Human-milk proteins: analysis of casein and casein subunits by anion-exchange chromatography, gel electrophoresis, and specific staining methods. Am J Clin Nutr. 1990 Jan;51(1):37-46. doi: 10.1093/ajcn/51.1.37.
citation: Llewellyn CH, van Jaarsveld CH, Johnson L, Carnell S, Wardle J. Development and factor structure of the Baby Eating Behaviour Questionnaire in the Gemini birth cohort. Appetite. 2011 Oct;57(2):388-96. doi: 10.1016/j.appet.2011.05.324. Epub 2011 Jun 6.
citation: Long T, Johnson M. Living and coping with excessive infantile crying. J Adv Nurs. 2001 Apr;34(2):155-62. doi: 10.1046/j.1365-2648.2001.01740.x.
citation: Manificat S, Dazord A, Langue J, Danjou G, Bauche P, Bovet F, Cubells J, Luchelli R, Tockert E, Conway K. [Evaluation of the quality of life of infants and very young children: validation of a questionnaire. Multicenter European study]. Arch Pediatr. 2000 Jun;7(6):605-14. doi: 10.1016/s0929-693x(00)80127-x. French.
citation: Mitchell DJ, McClure BG, Tubman TR. Simultaneous monitoring of gastric and oesophageal pH reveals limitations of conventional oesophageal pH monitoring in milk fed infants. Arch Dis Child. 2001 Mar;84(3):273-6. doi: 10.1136/adc.84.3.273.
citation: Nowacki J, Lee HC, Lien R, Cheng SW, Li ST, Yao M, Northington R, Jan I, Mutungi G. Stool fatty acid soaps, stool consistency and gastrointestinal tolerance in term infants fed infant formulas containing high sn-2 palmitate with or without oligofructose: a double-blind, randomized clinical trial. Nutr J. 2014 Nov 5;13:105. doi: 10.1186/1475-2891-13-105.
citation: Polack FP, Khan N, Maisels MJ. Changing partners: the dance of infant formula changes. Clin Pediatr (Phila). 1999 Dec;38(12):703-8. doi: 10.1177/000992289903801202.
citation: Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147.
citation: Recio I, Perez-Rodriguez ML, Amigo L, Ramos M. Study of the polymorphism of caprine milk caseins by capillary electrophoresis. J Dairy Res. 1997 Nov;64(4):515-23. doi: 10.1017/s0022029997002343.
citation: Savino F, Cresi F, Maccario S, Cavallo F, Dalmasso P, Fanaro S, Oggero R, Vigi V, Silvestro L. "Minor" feeding problems during the first months of life: effect of a partially hydrolysed milk formula containing fructo- and galacto-oligosaccharides. Acta Paediatr Suppl. 2003 Sep;91(441):86-90. doi: 10.1111/j.1651-2227.2003.tb00653.x.
citation: Zhou SJ, Sullivan T, Gibson RA, Lonnerdal B, Prosser CG, Lowry DJ, Makrides M. Nutritional adequacy of goat milk infant formulas for term infants: a double-blind randomised controlled trial. Br J Nutr. 2014 May;111(9):1641-51. doi: 10.1017/S0007114513004212. Epub 2014 Feb 6.