AsthmaNCT00178152
Erythema Toxicum Neonatorum in Newborns and the Development of Asthma
An observational study of Asthma and Erythema Toxicum Neonatorum, run by University of Rochester at 1 site in United States.
Trial summary
Erythema Toxicum Neonatorum (ETN) is a common skin finding that affects healthy full-term babies. Several authors have commented on the possible relationship between ETN and the development of atopic conditions, such as atopic dermatitis or respiratory disease later in life. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Asthma, Erythema Toxicum Neonatorum
- How many people
- 334 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Nov 2005
- Phase
- Observational
- 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 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Case studies will include subjects between the ages of 3-9 years who have had at least 2 asthma diagnoses within the last 2 years. Patients will be selected based upon their ICD9 codes for asthma. Control subjects will be age matched and without an asthma diagnosis.
Who may be able to join
- Children between the ages of 3-9 years who have had at least 2 asthma diagnoses within the last 2 years.
- Control subjects will be age matched and without an asthma diagnosis.
Who cannot join
- Children without accessible medical records
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Pediatrics, University of Rochester
Rochester, New York, 14642
About this study
Official title: The Implication of Erythema Toxicum Neonatorum in Newborns on the Development of Future Asthma
Erythema Toxicum Neonatorum (ETN) is a common skin finding that affects healthy full-term babies. Several authors have commented on the possible relationship between ETN and the development of atopic conditions, such as atopic dermatitis or respiratory disease later in life. There is a paucity of research addressing this issue.
- Conditions
- Asthma, Erythema Toxicum Neonatorum
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Investigators
- Jill S Halterman, MD, MPH, Principal investigator, University of RochesterRitu Pabby, MD, Study chair, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178152
- Sponsor's protocol ID
- 11627
- Status last verified
- May 2011
- First submitted
- 12 Sep 2005
- Last updated
- 12 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implication of Erythema Toxicum Neonatorum in Newborns on the Development of Future Asthma
- ClinicalTrials.gov ID
- NCT00178152
- Acronym / sponsor ID
- 11627
- Conditions
- Asthma, Erythema Toxicum Neonatorum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 15 Sep 2005 (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.
Erythema Toxicum Neonatorum (ETN) is a common skin finding that affects healthy full-term babies. Several authors have commented on the possible relationship between ETN and the development of atopic conditions, such as atopic dermatitis or respiratory disease later in life. There is a paucity of research addressing this issue.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Case studies will include subjects between the ages of 3-9 years who have had at least 2 asthma diagnoses within the last 2 years. Patients will be selected based upon their ICD9 codes for asthma. Control subjects will be age matched and without an asthma diagnosis.
Key inclusion criteria (2 listed)
- Children between the ages of 3-9 years who have had at least 2 asthma diagnoses within the last 2 years.
- Control subjects will be age matched and without an asthma diagnosis.
Key exclusion criteria (1 listed)
- Children without accessible medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 12 May 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.
Jill S Halterman, MD, MPH principal investigator
University of Rochester
Ritu Pabby, MD study chair
West Penn Allegheny Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Erythema Toxicum Neonatorum, run by University of Rochester at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 12 May 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 United States. 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.
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.
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 12 May 2011.