Treatment of Granuloma Umbilical in Newborn Babies

Pernille Pedersen90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fetus or Newborn Affected by Condition of Umbilical Cord

Interventions

silver nitratePROCEDURE

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

SteroidsDRUG

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

alcoholPROCEDURE

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.

Eligibility

Sex: ALLMin age: 3 WeeksMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Hvidovre Hospital

Kettegård Alle 31, Hvidovre, Denmark

Hvidovre University Hospital

Hvidovre, Kettegård Alle 30, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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