Treatment of residual Umbilical Tissues in newborn babies.

Conditions: Granuloma Umbilical
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2011-005300-15-DK

Lead Sponsor: niversity Hospital Hvidovre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Gestational age more than 37 weeks
More than 3 weeks old baby
With granuloma umbilica diagnosted by a pediatrician
No infections due to the umbilica
One of the parents do speak and understand Danish
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Gestational age below 37 weeks
less than 3 weeks of age
granuloma umbilical not diagnosted by a pedaitrician
infection due to the umbilica
none of the parents do speak or understand Danish

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Change current treatment of Granuloma Umbilica with Silver Nitrate to either steroid creme or better alcohol swaps with less side effects than seen wtih Silver Nitrate;Secondary Objective: Change treatment of Granuloma Umbilical from hospitals to home treatment;Primary end point(s): To show that steroid creme and better alcohol swaps are just as effective or equal to silver nitrat and have less side effects. Safer for the family and the child;Timepoint(s) of evaluation of this end point: 3 years

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 3 yeras;Secondary end point(s): To change treatment for granuloma umbilical in hospitals to treatment at home. Saving parents and child from visiting the hospital several times.<br>Also decreasing ressources used in hospital regi.