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Treatment of Granuloma Umbilical in Newborn Babies

This study is not yet open for participant recruitment.
Verified April 2012 by Hvidovre University Hospital
Sponsor:
Collaborator:
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
Pernille Pedersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01567215
First received: March 22, 2012
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

The investigators want to show that steroid creme and even better alcohol swaps are just as effective or equal to the current treatment with silver nitrate of granuloma umbilical in newborns.


Condition Intervention Phase
Fetus or Newborn Affected by Condition of Umbilical Cord
 Procedure: silver nitrate
Drug: Steroids
Procedure: alcohol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Granuloma Umbilical in Newborn Babies - Comparison of Treatment With Silver Nitrate Versus Alcohol Swaps Versus Steroid Creme Group IV

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Duration of treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    Duration/efficiency measured by:

    1. measuring the size of the granuloma twice a week in millimeters
    2. documenting the size taking photos of the granuloma twice a week
    3. days of treatment till the granuloma has disappeared ( endpoint )


Estimated Enrollment: 90
Study Start Date: May 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Granuloma Procedure: silver nitrate
Application 1 - 2 times a week for 3 - 4 weeks
Other Name: Product ATC code D08AL01
Drug: Steroids
Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.
Other Names:
  • Clobetasolpropionat 0,5 mg/g
  • ATC kode D07AD01
Procedure: alcohol
Alcohol swabs 82% ethanol. Application 6 - 8 times a day, each time the parents change the diaper. Treatment for 3 weeks or less if the granuloma disappears.
Other Name: 82% ethanol

Detailed Description:

The change of treatment will make it possible for parents to treat the children themselves at home, whereas treatment with silver nitrate only is an in hospital regimen.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gestational age more than 37 weeks
  • More than 3 weeks old baby
  • Granuloma umbilical diagnosed by a pediatrician
  • No infections due to the umbilicus
  • Parents do understand and speak danish

Exclusion Criteria:

  • Gestational age less than 37 weeks
  • Less than 3 weeks old baby
  • Granuloma umbilical not diagnosed by a pediatrician
  • Infections due to the umbilicus
  • Parents do not understand or speak Danish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567215

Contacts
Contact: Anne Brødsgaard Anne Brødsgaard, Nurse 38623129 anne.broedsgaard@hvh.regionh.dk
Contact: Pernille Pedersen Pernille Pedersen, Doctor 38623310 pernille.pedersen@hvh.regionh.dk

Locations
Denmark
Hvidovre Hospital
Kettegård Alle 31, Hvidovre, Denmark, 2650
Hvidovre University Hospital
Hvidovre, Kettegård alle 30, Denmark, 2650
Sponsors and Collaborators
Pernille Pedersen
Copenhagen University Hospital, Hvidovre
Investigators
Principal Investigator: Pernille Pedersen, Doctor Hvidovre University Hospital, Childrens apartement
  More Information

Publications:

Responsible Party: Pernille Pedersen, Doctor Pernille Pedersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01567215     History of Changes
Other Study ID Numbers: 201201, 2011-005300-15
Study First Received: March 22, 2012
Last Updated: April 10, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark:Approval from Datatilsynet to use journals
Denmark:GCP -unit Bispebjerg ( Good Clinical Practice ) is going to monitor the study

Keywords provided by Hvidovre University Hospital:
granuloma umbilical

Additional relevant MeSH terms:
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Ethanol
Silver Nitrate
Anti-Infective Agents, Local
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013