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

NCT ID: NCT01059045

Last Updated: 2010-06-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2009-12-31

Brief Summary

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.

Conditions

Hemangioma of Preterm Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryocontact therapy

Group Type: EXPERIMENTAL

cryocontact therapy

Intervention Type: PROCEDURE

cryocontact therapy of hemangioma is realized by using liquid nitrogen cooled metal devices

Control

Group Type: NO_INTERVENTION

cryocontact therapy

Intervention Type: PROCEDURE

cryocontact therapy of hemangioma is realized by using liquid nitrogen cooled metal devices

Control

Intervention Type: OTHER

No intervention

Interventions

cryocontact therapy

cryocontact therapy of hemangioma is realized by using liquid nitrogen cooled metal devices

Intervention Type: PROCEDURE

Control

No intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• preterm infants <=34 weeks GA with hemangioma

Exclusion Criteria

• no hemangioma

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 11 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Tuebingen

Principal Investigators

Rangmar Goelz, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital

Other Identifiers

CryoHaem

Identifier Type: -

Identifier Source: org_study_id