Treatment of Granuloma Umbilical in Newborn Babies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Granuloma Umbilical in Newborn Babies - Comparison of Treatment With Silver Nitrate Versus Alcohol Swaps Versus Steroid Creme Group IV

Conditions
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Fetus or Newborn Affected by Condition of Umbilical Cord

Intervention / Treatment
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* Procedure: silver nitrate
* Drug: Steroids
* Procedure: alcohol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Granuloma<br> | Procedure: silver nitrate<br>* Application 1 - 2 times a week for 3 - 4 weeks<br>* Other names: Product ATC code D08AL01;Drug: Steroids<br>* Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.<br>* Other names: ATC kode D07AD01;Procedure: alcohol<br>* 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.<br>* Other names: 82% ethanol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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granuloma umbilical