Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants
|ClinicalTrials.gov Identifier: NCT01059045|
Recruitment Status : Terminated (Recruitement was much slower than anticipated.)
First Posted : January 29, 2010
Last Update Posted : June 28, 2010
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
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.
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.
The study is approved by the Ethics Committee of Tuebingen University Hospital; all parents must give written informed consent.
|Condition or disease||Intervention/treatment|
|Hemangioma of Preterm Infants||Procedure: cryocontact therapy Other: Control|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants|
|Study Start Date :||August 2004|
|Study Completion Date :||December 2009|
|Experimental: Cryocontact therapy||
Procedure: cryocontact therapy
cryocontact therapy of hemangioma is realized by using liquid nitrogen cooled metal devices
|No Intervention: Control||
Procedure: cryocontact therapy
cryocontact therapy of hemangioma is realized by using liquid nitrogen cooled metal devicesOther: Control
- Hemangioma outcome [ Time Frame: 1 year ]skin status
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059045
|Principal Investigator:||Rangmar Goelz, MD||University Hospital|