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
|Condition or disease||Intervention/treatment||Phase|
|Fetus or Newborn Affected by Condition of Umbilical Cord||Procedure: silver nitrate Drug: Steroids Procedure: alcohol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||June 2014|
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
- 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.
- 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.
- 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?
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
|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|