We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Treatment of Granuloma Umbilical in Newborn Babies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01567215
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : July 2, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Fetus or Newborn Affected by Condition of Umbilical Cord Procedure: silver nitrate Drug: Steroids Procedure: alcohol Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2012
Primary Completion Date : February 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica? [ Time Frame: 2 years ]
    Change current treatment of Grauloma Umbilical. Show that alcohol swaps or steroid creme group IV are just as effective as current treatment of granuloma umbilica with silver nitrate.


Secondary Outcome Measures :
  1. Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents [ Time Frame: 2 years ]
    Change current treatment of granuloma umbilica with silver nitrate at hospitals to treatment at home by parents.


Other Outcome Measures:
  1. Avoid side effects by changing treatment of granuloma umbilical [ Time Frame: 2 years ]
    Severe side effect as skinburns is seen by using silver nitrate treating granuloma umbilica, using alcohol swabs or steroid creme less side effects are seen?


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567215


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 ( EudraCT Number )
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: June 2014

Keywords provided by Pernille Pedersen, 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
Central Nervous System Depressants
Physiological Effects of Drugs