Completed

NCT Number: NCT01567215

Treatment of Granuloma Umbilical in Newborn Babies

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.

Completed

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Key information

Conditions

Fetus or Newborn Affected by Condition of Umbilical Cord

Age range

3 week–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hvidovre Hospital, Kettegård Alle 31, Hvidovre, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silver nitrate

Procedure

Application 1 - 2 times a week for 3 - 4 weeks

Other names: Product ATC code D08AL01

Steroids

Drug

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

alcohol

Procedure

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

Primary outcomes

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.

Secondary outcomes

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.

Other outcomes

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?

Sponsors and collaborators

Lead sponsor

Pernille Pedersen

Other

Collaborators

Copenhagen University Hospital, Hvidovre

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Mar 30, 2012
Registry last updated: Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.