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

This study has been terminated.
(Recruitement was much slower than anticipated.)
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01059045
First received: January 28, 2010
Last updated: June 25, 2010
Last verified: August 2004
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   up to 11 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • preterm infants <=34 weeks GA with hemangioma

Exclusion Criteria:

  • no hemangioma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059045

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

No publications provided

Responsible Party: Rangmar Goelz, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01059045     History of Changes
Other Study ID Numbers: CryoHaem
Study First Received: January 28, 2010
Last Updated: June 25, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hemangioma
Hemangioma, Capillary
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on October 23, 2014