Treatment of Granuloma Umbilical in Newborn Babies
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.
Fetus or Newborn Affected by Condition of Umbilical Cord
Procedure: silver nitrate
|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|
- Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica? [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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.
- Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Change current treatment of granuloma umbilica with silver nitrate at hospitals to treatment at home by parents.
- Avoid side effects by changing treatment of granuloma umbilical [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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?
|Study Start Date:||May 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Procedure: silver nitrate
Application 1 - 2 times a week for 3 - 4 weeks
Other Name: Product ATC code D08AL01Drug: Steroids
Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.
Other Names: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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567215
|Kettegård Alle 31, Hvidovre, Denmark, 2650|
|Hvidovre University Hospital|
|Hvidovre, Kettegård alle 30, Denmark, 2650|
|Principal Investigator:||Pernille Pedersen, Doctor||Hvidovre University Hospital, Childrens apartement|