Fetus or Newborn Affected by Condition of Umbilical CordPhase 2NCT01567215
Treatment of Granuloma Umbilical in Newborn Babies
A Phase 2 study testing silver nitrate, Steroids and alcohol in people with Fetus or Newborn Affected by Condition of Umbilical Cord, run by Pernille Pedersen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 weeks to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Fetus or Newborn Affected by Condition of Umbilical Cord
- What is being tested?
- silver nitrate, Steroids and alcohol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 weeks to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre University Hospital
Hvidovre, Kettegård Alle 30, 2650
Hvidovre Hospital
Kettegård Alle 31, Hvidovre, 2650
About this study
Official title: Treatment of Granuloma Umbilical in Newborn Babies - Comparison of Treatment With Silver Nitrate Versus Alcohol Swaps Versus Steroid Creme Group IV
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.
Read the 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.
- Being tested
- silver nitrate, Steroids, alcohol
- Keywords
- granuloma umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver nitrateProcedure or surgery
Also called Product ATC code D08AL01
Application 1 - 2 times a week for 3 - 4 weeks
SteroidsDrug
Also called Clobetasolpropionat 0,5 mg/g, ATC kode D07AD01
Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.
alcoholProcedure or surgery
Also called 82% ethanol
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.
| Study group | Role | What they receive |
|---|---|---|
| Granuloma | Experimental | Not described Receives: Procedure: silver nitrate; Drug: Steroids; Procedure: alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetus or Newborn Affected by Condition of Umbilical CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pernille Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Responsible party
- Sponsor-investigator, Pernille Pedersen, Hvidovre University Hospital
- Investigators
- Pernille Pedersen, Doctor, Principal investigator, Hvidovre University Hospital, Childrens apartement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567215
- Sponsor's protocol ID
- 201201
- Other IDs
- 2011-005300-15
- Status last verified
- Jun 2014
- First submitted
- 22 Mar 2012
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001 Sep;17(7):513-4. doi: 10.1007/s003830100584.
PubMed 11666047
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Granuloma Umbilical in Newborn Babies - Comparison of Treatment With Silver Nitrate Versus Alcohol Swaps Versus Steroid Creme Group IV
- ClinicalTrials.gov ID
- NCT01567215
- Acronym / sponsor ID
- 201201
- Keywords
- granuloma umbilical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pernille PedersenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Study start
- May 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Granuloma | Experimental | Procedure: silver nitrate, Drug: Steroids, Procedure: alcohol |
Who may qualify
- Ages
- 3 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silver nitrateAlso: Product ATC code D08AL01Application 1 - 2 times a week for 3 - 4 weeks | Procedure or surgery | Granuloma |
| SteroidsAlso: Clobetasolpropionat 0,5 mg/g, ATC kode D07AD01Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears. | Drug | Granuloma |
| alcoholAlso: 82% ethanolAlcohol 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. | Procedure or surgery | Granuloma |
Primary outcome
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.
1 secondary outcome
Change of treatment of granuloma umbilical in hospitals by professionals to treatment at home by parents
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
- Background: PubMed 11666047Nagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001 Sep;17(7):513-4. doi: 10.1007/s003830100584.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille Pedersen, Doctor principal investigator
Hvidovre University Hospital, Childrens apartement
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing silver nitrate, Steroids and alcohol in people with Fetus or Newborn Affected by Condition of Umbilical Cord, run by Pernille Pedersen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is alcohol swabs and steroid creme as effective as lapis in treatment of granuloma umbilica? (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01567215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.