Back to resultsTreatment of Granuloma Umbilical in Newborn Babies
Primary Purpose
Fetus or Newborn Affected by Condition of Umbilical Cord
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
silver nitrate
Steroids
alcohol
Sponsored by
About this trial
This is an interventional treatment trial for Fetus or Newborn Affected by Condition of Umbilical Cord focused on measuring granuloma umbilical
Eligibility 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
Sites / Locations
- Hvidovre Hospital
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Granuloma
Arm Description
Outcomes
Primary Outcome Measures
Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica?
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
Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents
Change current treatment of granuloma umbilica with silver nitrate at hospitals to treatment at home by parents.
Full Information
NCT ID
NCT01567215
First Posted
March 22, 2012
Last Updated
June 30, 2014
Sponsor
Pernille Pedersen
Collaborators
Copenhagen University Hospital, Hvidovre
1. Study Identification
Unique Protocol Identification Number
NCT01567215
Brief Title
Treatment of Granuloma Umbilical in Newborn Babies
Official Title
Treatment of Granuloma Umbilical in Newborn Babies - Comparison of Treatment With Silver Nitrate Versus Alcohol Swaps Versus Steroid Creme Group IV
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pernille Pedersen
Collaborators
Copenhagen University Hospital, Hvidovre
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetus or Newborn Affected by Condition of Umbilical Cord
Keywords
granuloma umbilical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Granuloma
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
silver nitrate
Other Intervention Name(s)
Product ATC code D08AL01
Intervention Description
Application 1 - 2 times a week for 3 - 4 weeks
Intervention Type
Drug
Intervention Name(s)
Steroids
Other Intervention Name(s)
Clobetasolpropionat 0,5 mg/g, ATC kode D07AD01
Intervention Description
Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.
Intervention Type
Procedure
Intervention Name(s)
alcohol
Other Intervention Name(s)
82% ethanol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica?
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents
Description
Change current treatment of granuloma umbilica with silver nitrate at hospitals to treatment at home by parents.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Avoid side effects by changing treatment of granuloma umbilical
Description
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?
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernille Pedersen, Doctor
Organizational Affiliation
Hvidovre University Hospital, Childrens apartement
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital
City
Kettegård Alle 31
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Hvidovre University Hospital
City
Hvidovre
State/Province
Kettegård alle 30
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
11666047
Citation
Nagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001 Sep;17(7):513-4. doi: 10.1007/s003830100584.
Results Reference
background
Learn more about this trial
Treatment of Granuloma Umbilical in Newborn Babies
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