Treatment of Granuloma Umbilical in Newborn Babies

This study has been completed.
Sponsor:
Collaborator:
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
Pernille Pedersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01567215
First received: March 22, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Fetus or Newborn Affected by Condition of Umbilical Cord
Procedure: silver nitrate
Drug: Steroids
Procedure: alcohol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Granuloma Umbilical in Newborn Babies - Comparison of Treatment With Silver Nitrate Versus Alcohol Swaps Versus Steroid Creme Group IV

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica? [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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:
  • Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Change current treatment of granuloma umbilica with silver nitrate at hospitals to treatment at home by parents.


Other Outcome Measures:
  • Avoid side effects by changing treatment of granuloma umbilical [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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?


Enrollment: 90
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Granuloma Procedure: silver nitrate
Application 1 - 2 times a week for 3 - 4 weeks
Other Name: 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 Name: 82% ethanol

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567215

Locations
Denmark
Hvidovre Hospital
Kettegård Alle 31, Hvidovre, Denmark, 2650
Hvidovre University Hospital
Hvidovre, Kettegård alle 30, Denmark, 2650
Sponsors and Collaborators
Pernille Pedersen
Copenhagen University Hospital, Hvidovre
Investigators
Principal Investigator: Pernille Pedersen, Doctor Hvidovre University Hospital, Childrens apartement
  More Information

Publications:
Responsible Party: Pernille Pedersen, Doctor Pernille Pedersen, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01567215     History of Changes
Other Study ID Numbers: 201201, 2011-005300-15
Study First Received: March 22, 2012
Last Updated: June 30, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark:Approval from Datatilsynet to use journals
Denmark:GCP -unit Bispebjerg ( Good Clinical Practice ) is going to monitor the study

Keywords provided by Hvidovre University Hospital:
granuloma umbilical

Additional relevant MeSH terms:
Granuloma
Lymphatic Diseases
Lymphoproliferative Disorders
Pathologic Processes
Silver Nitrate
Anti-Infective Agents
Anti-Infective Agents, Local
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014