Treatment of residual Umbilical Tissues in newborn babies.

Treatment of Granuloma Umbilical in newborn babies - comparison of treatment with Silver Nitrate versus alcohol swaps versus steroid creme group IV. - Treatment of Granuloma Umbilical in newborn babies

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005300-15-DK

Enrollment

Registered

2012-03-06

Start date

2012-03-27

Completion date

Unknown

Last updated

2014-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granuloma Umbilical

Interventions

Trade Name: Silver nitrat - lapisstift ( Hollenstein-artstift ) Product Name: Silver nitrate Product Code: 231-853-9 Pharmaceutical Form: Cutaneous stick Trade Name: Dermovat steoid creme gruppe IV (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gestational age more than 37 weeks More than 3 weeks old baby With granuloma umbilica diagnosted by a pediatrician No infections due to the umbilica One of the parents do speak and understand Danish Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Gestational age below 37 weeks less than 3 weeks of age granuloma umbilical not diagnosted by a pedaitrician infection due to the umbilica none of the parents do speak or understand Danish

Design outcomes

Primary

Measure	Time frame
Main Objective: Change current treatment of Granuloma Umbilica with Silver Nitrate to either steroid creme or better alcohol swaps with less side effects than seen wtih Silver Nitrate;Secondary Objective: Change treatment of Granuloma Umbilical from hospitals to home treatment;Primary end point(s): To show that steroid creme and better alcohol swaps are just as effective or equal to silver nitrat and have less side effects. Safer for the family and the child;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Main Objective: Change current treatment of Granuloma Umbilica with Silver Nitrate to either steroid creme or better alcohol swaps with less side effects than seen wtih Silver Nitrate;Secondary Objective: Change treatment of Granuloma Umbilical from hospitals to home treatment;Primary end point(s): To show that steroid creme and better alcohol swaps are just as effective or equal to silver nitrat and have less side effects. Safer for the family and the child;Timepoint(s) of evaluation of this end point: 3 years

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 3 yeras;Secondary end point(s): To change treatment for granuloma umbilical in hospitals to treatment at home. Saving parents and child from visiting the hospital several times. Also decreasing ressources used in hospital regi.	—

Countries

Denmark

Contacts

Public ContactNeonatal apartement

Hvidovre Hospital

pernille.pedersen@hvh.regionh.dk+0045549738623310

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026