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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
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemangioma of Preterm Infants

Eligibility Criteria

1 Day - 11 Weeks (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 28, 2010
    Last Updated
    June 25, 2010
    Sponsor
    University Hospital Tuebingen
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    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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