Treatment of Granuloma Umbilical in Newborn Babies

June 30, 2014 updated by: Pernille Pedersen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Hvidovre
      • Kettegård Alle 31, Hvidovre, Denmark, 2650
        • Hvidovre Hospital
    • Kettegård alle 30
      • Hvidovre, Kettegård alle 30, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Granuloma
Procedure: silver nitrate
Application 1 - 2 times a week for 3 - 4 weeks
Other Names:
  • Product ATC code D08AL01
Drug: Steroids
Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.
Other Names:
  • Clobetasolpropionat 0,5 mg/g
  • ATC kode D07AD01
Procedure: alcohol
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.
Other Names:
  • 82% ethanol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica?
Time Frame: 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.
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
Time Frame: 2 years
Change current treatment of granuloma umbilica with silver nitrate at hospitals to treatment at home by parents.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Avoid side effects by changing treatment of granuloma umbilical
Time Frame: 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?
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pernille Pedersen

Collaborators

Copenhagen University Hospital, Hvidovre

Investigators

  • Principal Investigator: Pernille Pedersen, Doctor, Hvidovre University Hospital, Childrens apartement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 28, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

July 2, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201201
  • 2011-005300-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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