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Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants

This study has been terminated.
(Recruitement was much slower than anticipated.)
Information provided by:
University Hospital Tuebingen Identifier:
First received: January 28, 2010
Last updated: June 25, 2010
Last verified: August 2004

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 Intervention
Hemangioma of Preterm Infants
Procedure: cryocontact therapy
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants

Resource links provided by NLM:

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Hemangioma outcome [ Time Frame: 1 year ]
    skin status

Enrollment: 14
Study Start Date: August 2004
Study Completion Date: December 2009
Arms Assigned Interventions
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 devices
Other: Control
No intervention


Ages Eligible for Study:   up to 11 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • preterm infants <=34 weeks GA with hemangioma

Exclusion Criteria:

  • no hemangioma
  Contacts and Locations
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Please refer to this study by its identifier: NCT01059045

Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Rangmar Goelz, MD University Hospital
  More Information

Responsible Party: Rangmar Goelz, University Hospital Tuebingen Identifier: NCT01059045     History of Changes
Other Study ID Numbers: CryoHaem
Study First Received: January 28, 2010
Last Updated: June 25, 2010

Additional relevant MeSH terms:
Premature Birth
Hemangioma, Capillary
Port-Wine Stain
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Skin Abnormalities
Congenital Abnormalities
Skin Diseases processed this record on May 25, 2017