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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005300-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Copenhagen University Hospital, Hvidovre | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granuloma | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silver nitrate | Procedure | Application 1 - 2 times a week for 3 - 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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? | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernille Pedersen, Doctor | Hvidovre University Hospital, Childrens apartement | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital | Kettegård Alle 31 | Hvidovre | 2650 | Denmark | ||
| Hvidovre University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11666047 | Background | Nagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001 Sep;17(7):513-4. doi: 10.1007/s003830100584. |
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| ID | Term |
|---|---|
| D012835 | Silver Nitrate |
| D013256 | Steroids |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D009566 | Nitrates |
| D017942 | Nitric Acid |
| D017672 | Nitrogen Compounds |
| D007287 | Inorganic Chemicals |
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| Steroids | Drug | Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears. |
|
|
| alcohol | Procedure | 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. |
|
|
| Hvidovre |
| Kettegård Alle 30 |
| 2650 |
| Denmark |
| D018030 |
| Silver Compounds |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |