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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01059045
First Posted: January 29, 2010
Last Update Posted: June 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Tuebingen
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • preterm infants <=34 weeks GA with hemangioma

Exclusion Criteria:

  • no hemangioma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059045


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

Responsible Party: Rangmar Goelz, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01059045     History of Changes
Other Study ID Numbers: CryoHaem
First Submitted: January 28, 2010
First Posted: January 29, 2010
Last Update Posted: June 28, 2010
Last Verified: August 2004

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