Recurrent WheezingNCT01072552
Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants
An observational study of Recurrent Wheezing and Wheezing, run by Satoshi Kusuda at 1 site in Japan.
Trial summary
The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the severe RS virus infection during the infancy among preterm infants may reduce the risk of subsequent recurrent wheezing in childhood. Read more about this study
- Who is it for?
- Ages 3 months to 1 year
- Conditions the study is for
- Recurrent Wheezing, Wheezing, Asthma
- How many people
- 444 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2008to Aug 2011
- 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 months to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Infants with the gestational age between 33 and 35 weeks
Who may be able to join
- Infants born July ~ December 2007 at 33~35 weeks of gestation
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).
- Infants received less than 3 doses of palivizumab during the first 6 months of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)
The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the severe RS virus infection during the infancy among preterm infants may reduce the risk of subsequent recurrent wheezing in childhood.
The infants born between July 1st and December 31st in 2007 with the gestational age between 33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April 2008. The infants were unintentionally divided into two groups, either palivizumab treated or untreated group at the enrollment, because the timing for palivizumab prophylaxis were already ended.
Read more
The study infants will be followed up until the age of 3 with recording the incidence of either parent reported or physician diagnosed recurrent wheezing.
The difference of the incidence of the recurrent wheezing between the groups will be analyzed with Kaplan-Meier method.
- Conditions
- Recurrent Wheezing, Wheezing, Asthma
- Keywords
- recurrent wheezing, asthma, preterm infants, palivizumab, atopic diseases
- Medical subject headings
- Respiratory Sounds, Asthma
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.
Cumulative incidence of recurrent wheezing confirmed by physicians
Measured: two years
Secondary outcomes (5)
Cumulative incidence of recurrent wheezing confirmed by parents
Measured: two years
Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination
Measured: two years
Cumulative incidence of wheezing confirmed by parents
Measured: two years
Cumulative incidence of wheezing confirmed by physicians
Measured: two years
Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionAug 2011
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 Recurrent WheezingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satoshi Kusuda
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Committee of Recurrent Wheezing
- Responsible party
- Sponsor-investigator, Satoshi Kusuda, Tokyo Women's Medical University
- Investigators
- Sankei Nishima, MD, Study director, National Fukuoka HospitalKenji Okada, MD, Principal investigator, National Fukuoka Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072552
- Sponsor's protocol ID
- SCREW-001
- Status last verified
- Apr 2012
- First submitted
- 21 Dec 2009
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoshihara S, Kusuda S, Mochizuki H, Okada K, Nishima S, Simoes EA; C-CREW Investigators. Effect of palivizumab prophylaxis on subsequent recurrent wheezing in preterm infants. Pediatrics. 2013 Nov;132(5):811-8. doi: 10.1542/peds.2013-0982. Epub 2013 Oct 14.
PubMed 24127479
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)
- ClinicalTrials.gov ID
- NCT01072552
- Acronym / sponsor ID
- SCREW-001
- Conditions
- Recurrent Wheezing, Wheezing, Asthma
- Keywords
- recurrent wheezing, asthma, preterm infants, palivizumab, atopic diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Satoshi KusudaUniversity, hospital or other
- Collaborators
- Scientific Committee of Recurrent Wheezing
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Feb 2010 (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 hypothesis of the present study is that the prophylaxis with palivizumab to prevent the severe RS virus infection during the infancy among preterm infants may reduce the risk of subsequent recurrent wheezing in childhood.
The infants born between July 1st and December 31st in 2007 with the gestational age between 33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April 2008. The infants were unintentionally divided into two groups, either palivizumab treated or untreated group at the enrollment, because the timing for palivizumab prophylaxis were already ended.
The study infants will be followed up until the age of 3 with recording the incidence of either parent reported or physician diagnosed recurrent wheezing.
The difference of the incidence of the recurrent wheezing between the groups will be analyzed with Kaplan-Meier method.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | – | –Palivizumab treated |
| Untreated | – | –Palivizumab untreated |
Who may qualify
- Ages
- 3 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with the gestational age between 33 and 35 weeks
Key inclusion criteria (1 listed)
- Infants born July ~ December 2007 at 33~35 weeks of gestation
Key exclusion criteria (5 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).
- Infants received less than 3 doses of palivizumab during the first 6 months of life
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
Cumulative incidence of recurrent wheezing confirmed by physicians
Time frame: two years
5 secondary outcomes
Cumulative incidence of recurrent wheezing confirmed by parents
Time frame: two years
Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination
Time frame: two years
Cumulative incidence of wheezing confirmed by parents
Time frame: two years
Cumulative incidence of wheezing confirmed by physicians
Time frame: two years
Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases
Time frame: two 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 3 Apr 2012.
- Derived from this study: PubMed 24127479Yoshihara S, Kusuda S, Mochizuki H, Okada K, Nishima S, Simoes EA; C-CREW Investigators. Effect of palivizumab prophylaxis on subsequent recurrent wheezing in preterm infants. Pediatrics. 2013 Nov;132(5):811-8. doi: 10.1542/peds.2013-0982. Epub 2013 Oct 14.
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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.
Sankei Nishima, MD study director
National Fukuoka Hospital
Kenji Okada, MD principal investigator
National Fukuoka Hospital
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 Recurrent Wheezing and Wheezing, run by Satoshi Kusuda at 1 site in Japan.
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 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 3 Apr 2012. 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 Japan. 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.
What does the primary outcome measure?
Cumulative incidence of recurrent wheezing confirmed by physicians (time frame: two 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 NCT01072552, 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 3 Apr 2012.