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Unlabelled: In the last few years, evaluating quality of life in children has become possible using specific instruments; nevertheless, there is still an unsolved issue concerning the earliest ages, when the child is not able to give his/her own opinion. QUALIN, a new instrument designed to assess an infant's quality of life (between the ages of three months and three years) was developed from the study of spontaneous criteria used by parents or caregivers (paediatricians or nurses) when they think about the quality of life of a baby (preliminary survey including 800 open-ended questionnaires)., Patients and Methods: One thousand four hundred and twelve children under the age of three were included in this validation study. QUALIN questionnaire is a 34-item scale and can be completed by parents or caregivers. Two forms are available: one form is designed for children under the age of one and the other is designed for children between the ages of one and three. The QUALIN questionnaire was translated into English, Italian and Spanish, and a European multicentric validation study was conducted in Belgium, France, Italy, Luxembourg, Spain and Switzerland. Data were collected with QUALIN questionnaires from children's parents and paediatricians., Results: The psychometric properties of the scale are satisfactory (acceptability 90%, Cronbach's coefficient alpha over 0.75, correlations between two raters over 0.50, construct validity with principal component analysis showed emerging factors in agreement with the hypotheses linked to the questionnaire construction). The results are interesting, showing significant differences according to the health status of the children and their country of origin., Conclusion: The QUALIN questionnaire can be used for studies concerning the quality of life of children less than three years of age.