Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
1 other identifier
observational
42
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Aug 2013
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 4, 2011
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 10, 2015
November 1, 2015
2 years
January 3, 2011
November 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Airway reactivity
As assessed by methacholine challenge test with determination of PC20 and inflammatory mediators in exhaled breath condensate.
Between the 3 to 4 years-of-age
Secondary Outcomes (4)
Respiratory morbidity
every month
IgE
Between the 3 to 4 years-of-age
Eosinophil count
Between the 3 to 4 years-of-age
skin tests for inhaled allergens
Between the 3 to 4 years-of-age
Study Arms (2)
Born in 2007-2008
Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test.
Born in 2009-2010
Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test.
Interventions
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 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 site will be conducted at 6-month intervals in which physicians will record intercurrent doctor visits, emergency visits, and hospitalizations for respiratory symptoms.
For assessing IgE levels, Eosinophils count and cytokines levels
Participant blow tidal volume for determination of exhaled NO in Exhaled breath.
Eligibility Criteria
Premature babies 29-32 weeks of gestation born during 2007 and 2010
You may qualify if:
- Premature babies 29-32 weeks of gestation born during 2007 and 2010
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Medical Center
Haifa, 32000, Israel
Biospecimen
Whole blood for complete blood count , IGE and cytokines.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 4, 2011
Study Start
August 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
November 10, 2015
Record last verified: 2015-11