InfectionPhase 3NCT01369251
Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord
A Phase 3 study testing Hygiene and Usual alcohol care in people with Infection and Skin Diseases, Bacterial, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
Trial summary
The purpose of this study is to determinate whether in newborns just cleaning the umbilical stump when changing diapers (with water and soap if necessary)is effective in preventing local cord infections and not delaying cord separation as just as cord care alcohol, usually applied in our hospital and suggested to… Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Infection, Skin Diseases, Bacterial, Granuloma
- What is being tested?
- Hygiene and Usual alcohol care
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- May 2011to Dec 2012
- Phase
- Phase 3
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Appropriate for gestational age newborn
Who cannot join
- Not appropriate for gestational age newborn
Trial locations and contacts
1 site in 1 country.
Cristina Meroni contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale Luigi Sacco
Milan, 20157
Ludovica Tagliabue, tagliabue.ludovica@hsacco.it
About this study
Official title: Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord: a Randomized Clinical Trial
The purpose of this study is to determinate whether in newborns just cleaning the umbilical stump when changing diapers (with water and soap if necessary)is effective in preventing local cord infections and not delaying cord separation as just as cord care alcohol, usually applied in our hospital and suggested to parents at dismission.
- Conditions
- Infection, Skin Diseases, Bacterial, Granuloma
- Being tested
- Hygiene, Usual alcohol care
- Medical subject headings
- Infections, Skin Diseases, Bacterial, Granuloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HygieneBehavioural
Usual alcohol careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hygiene with water and soap | Experimental | Not described Receives: Behavioral: Hygiene |
| Usual alcohol care | Active comparator | Not described Receives: Procedure: Usual alcohol care |
What is being measured
The primary outcome is the main question the study is designed to answer.
omphalitis incidence
Secondary outcomes (2)
umbilical granuloma incidence
time to cord separation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Sponsor type
- University, hospital or other
- Investigators
- Cristina Meroni, Study director, ASST Fatebenefratelli SaccoMaria Teresa Garavaglia, Study chair, ASST Fatebenefratelli SaccoLudovica Tagliabue, MD, Principal investigator, Università di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369251
- Sponsor's protocol ID
- HSaccoCordCare
- Status last verified
- Apr 2011
- First submitted
- 7 Jun 2011
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simple Hygiene Versus Alcohol Based Usual Care for Umbilical Cord: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01369251
- Acronym / sponsor ID
- HSaccoCordCare
- Conditions
- Infection, Skin Diseases, Bacterial, Granuloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ASST Fatebenefratelli SaccoUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 8 Jun 2011 (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 purpose of this study is to determinate whether in newborns just cleaning the umbilical stump when changing diapers (with water and soap if necessary)is effective in preventing local cord infections and not delaying cord separation as just as cord care alcohol, usually applied in our hospital and suggested to parents at dismission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hygiene with water and soap | Experimental | Behavioral: Hygiene |
| Usual alcohol care | Active comparator | Procedure: Usual alcohol care |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Appropriate for gestational age newborn
Key exclusion criteria (1 listed)
- Not appropriate for gestational age newborn
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 |
|---|---|---|
| Hygiene | Behavioural | Hygiene with water and soap |
| Usual alcohol care | Procedure or surgery | Usual alcohol care |
Primary outcome
omphalitis incidence
2 secondary outcomes
umbilical granuloma incidence
time to cord separation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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.
Cristina Meroni contact
Cristina Meroni study director
ASST Fatebenefratelli Sacco
Maria Teresa Garavaglia study chair
ASST Fatebenefratelli Sacco
Ludovica Tagliabue, MD principal investigator
Università di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hygiene and Usual alcohol care in people with Infection and Skin Diseases, Bacterial, run by ASST Fatebenefratelli Sacco at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Meroni (meroni.cristina@hsacco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
omphalitis incidence. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2011.