Atopic AsthmaNCT01545245
Effects of Preventive Treatment for Respiratory Syncytial (RS) Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants
An observational study of Atopic Asthma and Recurrent Wheezing, run by Tokai University.
Trial summary
The primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections during the infancy. Read more about this study
- Who is it for?
- Ages 3 to 3 years
- Conditions the study is for
- Atopic Asthma, Recurrent Wheezing
- How many people
- 343 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jan 2014
- 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 3 years
- All sexes
- No healthy volunteers
- Child
Study population: The children who are participating in another on-going study, "Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants (ClinicalTrials.gov Identifier: NCT01072552)" and whose parents or legal guardian provide informed consent in writing for continuing participation in the study.
Who may be able to join
- Infants born July ~ December 2007 at 33~35 weeks of gestation
- Infants administered at least 3 doses of palivizumab during the first 6 months of life (Palivizumab treated)
- Infants not administered any doses of palivizumab during the first 6 months of life (Palivizumab untreated)
Who cannot join
- Intrauterine growth retardation (less than -2.5SD)
- Infants with chronic lung disease (CLD) or other respiratory disease
- Infants received mechanical ventilation
- Infants with chronic heart disease (CHD) or congenital anomaly (such as immunodeficiency)
About this study
Official title: Cohort Study to Evaluate Effects of Prophylactic Treatment for Respiratory Syncytial (RS) Virus Infection in Respiratory Tract During Infancy on Subsequent Atopic Asthma in Preterm Infants
The primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections during the infancy.
The secondary objective is to determine whether the incidence of recurrent wheezing after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy.
- Conditions
- Atopic Asthma, Recurrent Wheezing
- Keywords
- atopic asthma, recurrent wheezing, preterm infants, palivizumab, respiratory syncytial virus, RSV
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treated | Palivizumab treated | |
| Untreated | Palivizumab untreated |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy
Measured: For three years
Secondary outcomes (1)
The incidence of recurrent wheezing after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy
Measured: For three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startJul 2010
- Primary completionJan 2014
- Study completionJan 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 Atopic AsthmaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokai University
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Committee for Elucidation of Infantile Asthma
- Responsible party
- Principal investigator, Hiroyuki Mochizuki, Tokai University
- Investigators
- Hiroyuki Mochizuki, M.D., Ph.D.,, Principal investigator, Professor, Department of Pediatrics, Tokai University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545245
- Sponsor's protocol ID
- SCELIA study
- Status last verified
- Dec 2014
- First submitted
- 29 Feb 2012
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mochizuki H, Kusuda S, Okada K, Yoshihara S, Furuya H, Simoes EAF; Scientific Committee for Elucidation of Infantile Asthma. Palivizumab Prophylaxis in Preterm Infants and Subsequent Recurrent Wheezing. Six-Year Follow-up Study. Am J Respir Crit Care Med. 2017 Jul 1;196(1):29-38. doi: 10.1164/rccm.201609-1812OC.
PubMed 28152315
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study to Evaluate Effects of Prophylactic Treatment for Respiratory Syncytial (RS) Virus Infection in Respiratory Tract During Infancy on Subsequent Atopic Asthma in Preterm Infants
- ClinicalTrials.gov ID
- NCT01545245
- Acronym / sponsor ID
- SCELIA study
- Conditions
- Atopic Asthma, Recurrent Wheezing
- Keywords
- atopic asthma, recurrent wheezing, preterm infants, palivizumab, respiratory syncytial virus, RSV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Tokai UniversityUniversity, hospital or other
- Collaborators
- Scientific Committee for Elucidation of Infantile Asthma
- Study start
- Jul 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 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 primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections during the infancy.
The secondary objective is to determine whether the incidence of recurrent wheezing after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | – | –Palivizumab treated |
| Untreated | – | –Palivizumab untreated |
Who may qualify
- Ages
- 3 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The children who are participating in another on-going study, "Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants (ClinicalTrials.gov Identifier: NCT01072552)" and whose parents or legal guardian provide informed consent in writing for continuing participation in the study.
Key inclusion criteria (3 listed)
- Infants born July ~ December 2007 at 33~35 weeks of gestation
- Infants administered at least 3 doses of palivizumab during the first 6 months of life (Palivizumab treated)
- Infants not administered any doses of palivizumab during the first 6 months of life (Palivizumab untreated)
Key exclusion criteria (4 listed)
- Intrauterine growth retardation (less than -2.5SD)
- Infants with chronic lung disease (CLD) or other respiratory disease
- Infants received mechanical ventilation
- Infants with chronic heart disease (CHD) or congenital anomaly (such as immunodeficiency)
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
The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy
Time frame: For three years
1 secondary outcome
The incidence of recurrent wheezing after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy
Time frame: For three 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 8 Dec 2014.
- Derived from this study: PubMed 28152315Mochizuki H, Kusuda S, Okada K, Yoshihara S, Furuya H, Simoes EAF; Scientific Committee for Elucidation of Infantile Asthma. Palivizumab Prophylaxis in Preterm Infants and Subsequent Recurrent Wheezing. Six-Year Follow-up Study. Am J Respir Crit Care Med. 2017 Jul 1;196(1):29-38. doi: 10.1164/rccm.201609-1812OC.
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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.
Hiroyuki Mochizuki, M.D., Ph.D., principal investigator
Professor, Department of Pediatrics, Tokai University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Asthma and Recurrent Wheezing, run by Tokai University.
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 3 inclusion and 4 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 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy (time frame: For three 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 NCT01545245, 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 8 Dec 2014.