Bronchial HyperreactivityNCT01269528
Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
An observational study of Bronchial Hyperreactivity and Infant, Premature, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Protocol Synopsis: There is a link between early RSV infection and chronic respiratory morbidity. Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory morbidity. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Bronchial Hyperreactivity, Infant, Premature
- What is being tested?
- Methacholine Challenge Test (MCT), Monthly telephone contact and Visits to the study site
- How many people
- 42 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Aug 2015
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Premature babies 29-32 weeks of gestation born during 2007 and 2010
Who may be able to join
- Premature babies 29-32 weeks of gestation born during 2007 and 2010
Who cannot join
- Any mechanical ventilation
- Chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies
- Known immunodeficiency
- Receipt of other RSV investigative vaccines or therapies
Trial locations and contacts
1 site in 1 country.
About this study
Protocol Synopsis: There is a link between early RSV infection and chronic respiratory morbidity.
Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory morbidity.
Read more
Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity (AHR) in children born at 29-32 weeks.
Secondary objective: to assess prospectively the effect of palivizumab on respiratory morbidity airway inflammation and allergy in children born at 29-32 weeks.
Inclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.
Exclusion criteria: Any mechanical ventilation or chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known immunodeficiency, or receipt of other RSV investigative vaccines or therapies.
Primary end points: Airway reactivity as assessed by methacholine challenge test with determination of PC20.
Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.
Sample size: 74 participants; Group I - 37 premature babies at 29-32 weeks of gestation born during 2007-2008 (before approval of Synagis for this group in Israel). Group II - 37 premature babies 29-32 weeks of gestation born during 2009-2010 (after approval of Synagis for this group in Israel).
Statistics: A sample size of 37 patients was calculated as necessary to detect a difference of 0.5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline characteristics will be compared using 1-way analysis of variance for quantitative variables and Fisher's exact test for categorical variables.
Read the detailed description
Protocol Synopsis: There is a link between early RSV infection and chronic respiratory morbidity.
Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory morbidity.
Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity (AHR) in children born at 29-32 weeks.
Secondary objective: to assess prospectively the effect of palivizumab on respiratory morbidity airway inflammation and allergy in children born at 29-32 weeks.
Inclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.
Exclusion criteria: Any mechanical ventilation or chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known immunodeficiency, or receipt of other RSV investigative vaccines or therapies.
Primary end points: Airway reactivity as assessed by methacholine challenge test with determination of PC20.
Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.
Sample size: 74 participants; Group I - 37 premature babies at 29-32 weeks of gestation born during 2007-2008 (before approval of Synagis for this group in Israel). Group II - 37 premature babies 29-32 weeks of gestation born during 2009-2010 (after approval of Synagis for this group in Israel).
Statistics: A sample size of 37 patients was calculated as necessary to detect a difference of 0.5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline characteristics will be compared using 1-way analysis of variance for quantitative variables and Fisher's exact test for categorical variables..
- Conditions
- Bronchial Hyperreactivity, Infant, Premature
- Being tested
- Methacholine Challenge Test (MCT), Monthly telephone contact, Visits to the study site, Blood Test, Fractional exhaled nitric oxide
- Keywords
- Palivizumab, Airway Hyperreactivity, EBC, MCT
- Medical subject headings
- Bronchial Hyperreactivity, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine Challenge Test (MCT)Other
MCT challenge with determination of methacholine concentration that causes a 20% decrease from baseline FEV1 (forced expiratory volume in the 1st second of expiration) - PC20-FEV1 - is a well-documented method of assessing bronchial hyper-reactivity (BHR) in both adults and children. Our group has shown that the determination of PC20 by spirometry is feasible in preschool children. MCT is considered safe in this age group and our group has extensive experience with no adverse events. In the current study MCT will be performed (for the first time) in premature babies born at 30-32 weeks of gestation during 2008-2009 when they reach the age of 3-4 years (2011 and 2012, respectively). The results of MCT of the two groups will be compared.
Monthly telephone contactOther
Monthly telephone contact with the parents/caregivers will be scheduled from enrollment until the final visit at age 3-4 years. Subject illnesses and other medical events occurring during the past month will be recorded at each monthly follow-up.
Visits to the study siteOther
Visits to the study site will be conducted at 6-month intervals in which physicians will record intercurrent doctor visits, emergency visits, and hospitalizations for respiratory symptoms.
Blood TestOther
For assessing IgE levels, Eosinophils count and cytokines levels
Fractional exhaled nitric oxideOther
Participant blow tidal volume for determination of exhaled NO in Exhaled breath.
| Study group | Role | What they receive |
|---|---|---|
| Born in 2007-2008 | Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Receives: Other: Methacholine Challenge Test (MCT); Other: Monthly telephone contact; Other: Visits to the study site; Other: Blood Test; Other: Fractional exhaled nitric oxide | |
| Born in 2009-2010 | Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Receives: Other: Methacholine Challenge Test (MCT); Other: Monthly telephone contact; Other: Visits to the study site; Other: Blood Test; Other: Fractional exhaled nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway reactivity
As assessed by methacholine challenge test with determination of PC20 and inflammatory mediators in exhaled breath condensate.
Measured: Between the 3 to 4 years-of-age
Secondary outcomes (4)
Respiratory morbidity
Monthly telephone contact with the parents/caregivers will be scheduled from enrollement until the final visit at age 3-4 years. Visits to the study site will be conducted at 6-month intervals. Subject illnesses and other medical events occurring during the past month will be recorded at each monthly follow-up. At 6-month intervals, physicians will record intercurrent doctor visits, emergency visits, and hospitalizations for respiratory symptoms.
Measured: every month
IgE
in pereferal Blood count
Measured: Between the 3 to 4 years-of-age
Eosinophil count
in pereferal Blood count
Measured: Between the 3 to 4 years-of-age
skin tests for inhaled allergens
Measured: Between the 3 to 4 years-of-age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial HyperreactivityStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269528
- Sponsor's protocol ID
- Evaluation of Palivizumab
- Status last verified
- Nov 2015
- First submitted
- 3 Jan 2011
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT01269528
- Acronym / sponsor ID
- Evaluation of Palivizumab
- Conditions
- Bronchial Hyperreactivity, Infant, Premature
- Keywords
- Palivizumab, Airway Hyperreactivity, EBC, MCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Jan 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.
Protocol Synopsis: There is a link between early RSV infection and chronic respiratory morbidity.
Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory morbidity.
Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity (AHR) in children born at 29-32 weeks.
Secondary objective: to assess prospectively the effect of palivizumab on respiratory morbidity airway inflammation and allergy in children born at 29-32 weeks.
Inclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.
Exclusion criteria: Any mechanical ventilation or chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known immunodeficiency, or receipt of other RSV investigative vaccines or therapies.
Primary end points: Airway reactivity as assessed by methacholine challenge test with determination of PC20.
Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.
Sample size: 74 participants; Group I - 37 premature babies at 29-32 weeks of gestation born during 2007-2008 (before approval of Synagis for this group in Israel). Group II - 37 premature babies 29-32 weeks of gestation born during 2009-2010 (after approval of Synagis for this group in Israel).
Statistics: A sample size of 37 patients was calculated as necessary to detect a difference of 0.5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline characteristics will be compared using 1-way analysis of variance for quantitative variables and Fisher's exact test for categorical variables.
Detailed description
Protocol Synopsis: There is a link between early RSV infection and chronic respiratory morbidity.
Hypothesis: Palivizumab administration may result in decreased AHR and lower respiratory morbidity.
Primary objective: to evaluate prospectively the effect of palivizumab on airway reactivity (AHR) in children born at 29-32 weeks.
Secondary objective: to assess prospectively the effect of palivizumab on respiratory morbidity airway inflammation and allergy in children born at 29-32 weeks.
Inclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.
Exclusion criteria: Any mechanical ventilation or chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies, known immunodeficiency, or receipt of other RSV investigative vaccines or therapies.
Primary end points: Airway reactivity as assessed by methacholine challenge test with determination of PC20.
Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.
Sample size: 74 participants; Group I - 37 premature babies at 29-32 weeks of gestation born during 2007-2008 (before approval of Synagis for this group in Israel). Group II - 37 premature babies 29-32 weeks of gestation born during 2009-2010 (after approval of Synagis for this group in Israel).
Statistics: A sample size of 37 patients was calculated as necessary to detect a difference of 0.5 SD in AHR for a 2-sided tail, with a power of 80%. Demographics and baseline characteristics will be compared using 1-way analysis of variance for quantitative variables and Fisher's exact test for categorical variables..
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Born in 2007-2008 | – | Other: Methacholine Challenge Test (MCT), Other: Monthly telephone contact, Other: Visits to the study site, Other: Blood Test, Other: Fractional exhaled nitric oxideMethacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. |
| Born in 2009-2010 | – | Other: Methacholine Challenge Test (MCT), Other: Monthly telephone contact, Other: Visits to the study site, Other: Blood Test, Other: Fractional exhaled nitric oxideMethacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature babies 29-32 weeks of gestation born during 2007 and 2010
Key inclusion criteria (1 listed)
- Premature babies 29-32 weeks of gestation born during 2007 and 2010
Key exclusion criteria (4 listed)
- Any mechanical ventilation
- Chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies
- Known immunodeficiency
- Receipt of other RSV investigative vaccines or therapies
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 |
|---|---|---|
| Methacholine Challenge Test (MCT)MCT challenge with determination of methacholine concentration that causes a 20% decrease from baseline FEV1 (forced expiratory volume in the 1st second of expiration) - PC20-FEV1 - is a well-documented method of assessing bronchial hyper-reactivity (BHR) in both adults and children. Our group has shown that the determination of PC20 by spirometry is feasible in preschool children. MCT is considered safe in this age group and our group has extensive experience with no adverse events. In the current study MCT will be performed (for the first time) in premature babies born at 30-32 weeks of gestation during 2008-2009 when they reach the age of 3-4 years (2011 and 2012, respectively). The results of MCT of the two groups will be compared. | Other | Born in 2007-2008, Born in 2009-2010 |
| Monthly telephone contactMonthly telephone contact with the parents/caregivers will be scheduled from enrollment until the final visit at age 3-4 years. Subject illnesses and other medical events occurring during the past month will be recorded at each monthly follow-up. | Other | Born in 2007-2008, Born in 2009-2010 |
| Visits to the study siteVisits to the study site will be conducted at 6-month intervals in which physicians will record intercurrent doctor visits, emergency visits, and hospitalizations for respiratory symptoms. | Other | Born in 2007-2008, Born in 2009-2010 |
| Blood TestFor assessing IgE levels, Eosinophils count and cytokines levels | Other | Born in 2007-2008, Born in 2009-2010 |
| Fractional exhaled nitric oxideParticipant blow tidal volume for determination of exhaled NO in Exhaled breath. | Other | Born in 2007-2008, Born in 2009-2010 |
Primary outcome
Airway reactivity
Time frame: Between the 3 to 4 years-of-age
As assessed by methacholine challenge test with determination of PC20 and inflammatory mediators in exhaled breath condensate.
4 secondary outcomes
Respiratory morbidity
Time frame: every month
IgE
Time frame: Between the 3 to 4 years-of-age
Eosinophil count
Time frame: Between the 3 to 4 years-of-age
skin tests for inhaled allergens
Time frame: Between the 3 to 4 years-of-age
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 10 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bronchial Hyperreactivity and Infant, Premature, run by Rambam Health Care Campus at 1 site in Israel.
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 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 10 Nov 2015. 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 Israel. 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?
Airway reactivity (time frame: Between the 3 to 4 years-of-age). 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 10 Nov 2015.