Treatment of Granuloma Umbilical in Newborn Babies

Fetus or Newborn Affected by Condition of Umbilical Cord Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567215
• Other study ID #: 201201
• Secondary ID: 2011-005300-15
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2012
• Last updated: June 30, 2014
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark:Approval from Datatilsynet to use journalsDenmark:GCP -unit Bispebjerg ( Good Clinical Practice ) is going to monitor the study
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetus or Newborn Affected by Condition of Umbilical Cord
• Granuloma

Intervention

Procedure:
• silver nitrate
Application 1 - 2 times a week for 3 - 4 weeks

Drug:
• Steroids
Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.

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.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre	Kettegård alle 30
Denmark	Hvidovre Hospital	Kettegård Alle 31	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Pernille Pedersen	Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Nagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001 Sep;17(7):513-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Avoid side effects by changing treatment of granuloma umbilical	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	Yes
Primary	Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica?	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	Yes
Secondary	Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents	Change current treatment of granuloma umbilica with silver nitrate at hospitals to treatment at home by parents.	2 years	Yes