Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants
Primary Purpose
Hemangioma of Preterm Infants
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cryocontact therapy
Control
Sponsored by
About this trial
This is an interventional treatment trial for Hemangioma of Preterm Infants
Eligibility Criteria
Inclusion Criteria:
- preterm infants <=34 weeks GA with hemangioma
Exclusion Criteria:
- no hemangioma
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cryocontact therapy
Control
Arm Description
Outcomes
Primary Outcome Measures
Hemangioma outcome
skin status
Secondary Outcome Measures
Full Information
NCT ID
NCT01059045
First Posted
January 28, 2010
Last Updated
June 25, 2010
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT01059045
Brief Title
Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants
Official Title
Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Terminated
Why Stopped
Recruitement was much slower than anticipated.
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma of Preterm Infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryocontact therapy
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
cryocontact therapy
Intervention Description
cryocontact therapy of hemangioma is realized by using liquid nitrogen cooled metal devices
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Hemangioma outcome
Description
skin status
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
11 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
preterm infants <=34 weeks GA with hemangioma
Exclusion Criteria:
no hemangioma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rangmar Goelz, MD
Organizational Affiliation
University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants
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