Treatment of Granuloma Umbilical in Newborn Babies

Pernille Pedersen

Status and phase: Completed; Phase 2

Conditions: Fetus or Newborn Affected by Condition of Umbilical Cord

Treatments: Procedure: alcohol; Drug: Steroids; Procedure: silver nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01567215

201201

2011-005300-15 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 3 weeks to 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Granuloma

Experimental group

Treatment:

Drug: Steroids

Procedure: silver nitrate

Procedure: alcohol