A Phase 2 interventional study of silver nitrate and Steroids in Fetus or Newborn Affected by Condition of Umbilical Cord, sponsored by Pernille Pedersen. Completed at 2 sites in Denmark. Open to participants aged 3 Weeks to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-02.
Sponsored by Pernille Pedersen · Phase 2, Interventional, and Treatment
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.
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.
79 studies on the registry are indexed under Granuloma; 8 are open to participants now.
This study's enrollment of 90 is above the median of 25 across 56 interventional studies indexed under Granuloma.
Browse Granuloma studies →This is the only study on the registry with Pernille Pedersen as lead sponsor.
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Exclusion Criteria:
Procedure: silver nitrate · Drug: Steroids · Procedure: alcohol
Application 1 - 2 times a week for 3 - 4 weeks
Also known as: Product ATC code D08AL01
Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.
Also known as: Clobetasolpropionat 0,5 mg/g, ATC kode D07AD01
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.
Also known as: 82% ethanol
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.
Time frame: 2 years
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.
Time frame: 2 years
Avoid side effects by changing treatment of granuloma umbilical
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
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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