Prospective controlled study to evaluate cryocontact therapy for infantile haemangioma in preterm infants

摘要

Despite the high prevalence of infantile haemangioma (IH) of preterm infants, methods for treating it have not yet been evaluated in controlled trials. Therefore, we conducted a prospective controlled study, comparing nitrogen-cooled cryocontact therapy (NCCT,-196°C) for early treatment of IH in preterm infants with no treatment. From 1 August 2004 to 31 December 2008, we allocated IH of infants <34 weeks gestational age with at least two IH into either a cryocontact or a control group, thus using intraindividual controls to exclude interpersonal differences potentially affecting growth. If IH appeared simultaneously, they were numbered from head to foot; even numbers were treated, odd numbers served as controls. In sequentially erupting IH, always the second one was treated, and in critical locations (face, skull, joints and anogenital region) IHs were always primarily treated. NCCT was achieved by using a metal cylinder of variable diameter (max 10 mm) cooled by liquid nitrogen to cover and compress just the maximum IH diameter. We hypothesised that NCCT shows more successful resolutions than no therapy. The primary endpoint, at 1 or 2 years corrected age, was intact skin with mild or no pigmentation, without haemangioma or scar formation.