Hemangioma of Preterm Infants Clinical Trial
Official title:
Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants
Prospective controlled study evaluating cryocontact therapy of infantile hemangiomas of
preterm infants
Principal investigator: Rangmar Goelz, MD Coworkers: M Möhrle, M Moll, HM Häfner, W
Schippert, C Meisner, M Röcken, CF Poets
Background Despite their frequent occurrence, there is no established therapeutic procedure
for localized infantile hemangioma in preterm infants. A PubMed search with the key words
hemangioma, controlled study, infant or childhood revealed five studies (1-5), none of them
included preterm infants, even though low birth weight and prematurity have been described
as the most significant risk factors
Aim:
To evaluate cryocontact therapy of infantile hemangioma (IH) of 1 - 10 mm diameter in
preterm infants <=34 weeks of gestational age (GA) using a liquid nitrogen cooled metal at
the Department of Neonatology at the Tuebingen University Hospital.
Method:
In a prospective controlled study, preterm infants <= 34 weeks GA with at least 2 IH should
be randomized to have one treated with cryocontact therapy using a liquid nitrogen cooled
metal (-196°C), while the other one is left untreated. Primary endpoint is an intact skin at
the site of the hemangioma at 1 year corrected age . The study starts at August 1st, 2004.
Cryocontact is done by 3 trained dermatologist (MM, HMH, WS), outcome documentation,
including photodocumentation, by 2 neonatologist (RG, MoMo).
Statistical Analysis: A sample size of 25 intrapersonal pairs of treated and untreated IH is
needed to show a significant difference with alpha=0.05 and beta=0.9 between treated IH and
controls, assuming that 5% of the treated IH and 40% of the controls have an unsuccessful
primary outcome. Documentation will be made on standardized forms and the data will be
transferred to Excel. Biometric calculations will be handled with SAS 9.1.3. for Windows
using Fisher´s Exact Test for difference in proportions.
Ethics:
The study is approved by the Ethics Committee of Tuebingen University Hospital; all parents
must give written informed consent.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment