Fetus or Newborn Affected by Condition of Umbilical Cord
Conditions
Keywords
granuloma umbilical
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.
Detailed description
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.
Interventions
PROCEDUREsilver nitrate
Application 1 - 2 times a week for 3 - 4 weeks
DRUGSteroids
Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.
PROCEDUREalcohol
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.
Sponsors
Copenhagen University Hospital, Hvidovre
Pernille Pedersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica? | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents | 2 years | Change current treatment of granuloma umbilica with silver nitrate at hospitals to treatment at home by parents. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Avoid side effects by changing treatment of granuloma umbilical | 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? |
Countries
Denmark
Outcome results
None listed