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

NCT01059045 | Terminated DMC

• 1 other identifier: CryoHaem
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Hemangioma outcome

  skin status

  1 year

Study Arms (2)

Cryocontact therapy

EXPERIMENTAL

Procedure: cryocontact therapy

Control

NO INTERVENTION

Procedure: cryocontact therapy; Other: Control

Interventions

cryocontact therapy PROCEDURE

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

Control; Cryocontact therapy

Control OTHER

No intervention

Control

Eligibility Criteria

• Age: 1 Day - 11 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm infants \<=34 weeks GA with hemangioma

You may not qualify if:

• no hemangioma

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Officials

• Rangmar Goelz, MD

  University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: January 29, 2010
• Study Start: August 1, 2004
• Study Completion: December 1, 2009
• Last Updated: June 28, 2010

Record last verified: 2004-08