Backround:Infantile haemangiomas are the most common benign tumours of the child with clinical manifestations in the first two years of life, which is an additional cause of parents' concerns. Objective:This study describes the first stage in elaborating a specific instrument to evaluate the quality of life of both patients with infantile haemangioma under two years of age and their parents, adapted to the reality of the Romanian context. Methods:Items were generated from a literature review - from both the current generic pediatricians' instruments and specific tools in dermatology for assessing quality of life and the existing consensus among experts - as well as from a qualitative analysis of parents' concerns. The instrument was piloted on a group of patients' relatives. Results:We have developed a 28-item specific infantile haemangioma quality of life questionnaire with four sub-scales to assess physical health, the social function of the child, parents' emotional health and the social function of parents. Demographic data and clinical features (meanings of symptoms and outcomes) that have an impact on the quality of life were obtained. Conclusion:It is important to be able to measure and compare the quality of life of both patients with infantile haemangioma and their parents for adapting the treatment to the specific needs of patients and their family. The effectiveness of new therapeutic options which are especially useful for infants with haemangiomas can be checked by using the questionnaire as a measure of patient-reported outcome. The questionnaire developed by us was well accepted by the patients' parents.