Treatment of Granuloma Umbilical in Newborn Babies
2 other identifiers
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 30, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJuly 2, 2014
June 1, 2014
1.8 years
March 22, 2012
June 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (1)
Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents
2 years
Other Outcomes (1)
Avoid side effects by changing treatment of granuloma umbilical
2 years
Study Arms (1)
Granuloma
EXPERIMENTALInterventions
Application 1 - 2 times a week for 3 - 4 weeks
Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pernille Pedersenlead
- Copenhagen University Hospital, Hvidovrecollaborator
Study Sites (2)
Hvidovre Hospital
Kettegård Alle 31, Hvidovre, 2650, Denmark
Hvidovre University Hospital
Hvidovre, Kettegård Alle 30, 2650, Denmark
Related Publications (1)
Nagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001 Sep;17(7):513-4. doi: 10.1007/s003830100584.
PMID: 11666047BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pernille Pedersen, Doctor
Hvidovre University Hospital, Childrens apartement
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor Pernille Pedersen
Study Record Dates
First Submitted
March 22, 2012
First Posted
March 30, 2012
Study Start
May 1, 2012
Primary Completion
February 1, 2014
Study Completion
June 1, 2014
Last Updated
July 2, 2014
Record last verified: 2014-06