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Treatment of Granuloma Umbilical in Newborn Babies

Information source: Hvidovre University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fetus or Newborn Affected by Condition of Umbilical Cord

Intervention: silver nitrate (Procedure); Steroids (Drug); alcohol (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: Pernille Pedersen

Official(s) and/or principal investigator(s):
Pernille Pedersen, Doctor, Principal Investigator, Affiliation: Hvidovre University Hospital, Childrens apartement

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.

Clinical Details

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

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

Primary outcome: Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica?

Secondary outcome: Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents

Detailed 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.

Eligibility

Minimum age: N/A. Maximum age: 6 Months. Gender(s): Both.

Criteria:

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 and Contacts

Hvidovre Hospital, KettegÄrd Alle 31, Hvidovre 2650, Denmark

Hvidovre University Hospital, Hvidovre, KettegÄrd alle 30 2650, Denmark

Additional Information

Related publications:

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

Starting date: May 2012
Last updated: June 30, 2014

Page last updated: August 23, 2015

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