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

March 22, 2012
June 30, 2014
May 2012
February 2014   (final data collection date for primary outcome measure)
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.
Duration of treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Duration/efficiency measured by:

  1. measuring the size of the granuoloma twice a week in millimeters
  2. documenting the size taking fotos of the granuloma twice a week
  3. days of treatment till the granuloma has disapeared ( endpoint )
Complete list of historical versions of study NCT01567215 on ClinicalTrials.gov Archive Site
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.
Not Provided
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?
Not Provided
 
Treatment of Granuloma Umbilical in Newborn Babies
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fetus or Newborn Affected by Condition of Umbilical Cord
  • 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
Experimental: Granuloma
Interventions:
  • Procedure: silver nitrate
  • Drug: Steroids
  • Procedure: alcohol
Nagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001 Sep;17(7):513-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
June 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
up to 6 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01567215
201201, 2011-005300-15
Yes
Pernille Pedersen, Hvidovre University Hospital
Pernille Pedersen
Copenhagen University Hospital, Hvidovre
Principal Investigator: Pernille Pedersen, Doctor Hvidovre University Hospital, Childrens apartement
Hvidovre University Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP