Treatment of Granuloma Umbilical in Newborn Babies

Phase 2

Completed

• Conditions: Fetus or Newborn Affected by Condition of Umbilical Cord
• Interventions: Procedure: silver nitrate; Drug: Steroids; Procedure: alcohol

• Registration Number: NCT01567215
• Lead Sponsor: Pernille Pedersen

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.

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-30
• Study Start: 2012-05
• Primary Completion: 2014-02
• Status Verified: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Granuloma	silver nitrate	-
Granuloma	Steroids	-
Granuloma	alcohol	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Kettegård alle 30, Denmark

Hvidovre Hospital; 🇩🇰 Kettegård Alle 31, Hvidovre, Denmark