Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
- Conditions
- Bronchial HyperreactivityInfant, Premature
- Interventions
- Other: Methacholine Challenge Test (MCT)Other: Monthly telephone contactOther: Visits to the study siteOther: Blood TestOther: Fractional exhaled nitric oxide
- Registration Number
- NCT01269528
- Lead Sponsor
- Rambam Health Care Campus
- 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.
- 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..
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Premature babies 29-32 weeks of gestation born during 2007 and 2010
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Born in 2007-2008 Monthly telephone contact Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Born in 2007-2008 Visits to the study site Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Born in 2009-2010 Fractional exhaled nitric oxide Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Born in 2007-2008 Methacholine Challenge Test (MCT) Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Born in 2007-2008 Blood Test Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Born in 2007-2008 Fractional exhaled nitric oxide 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) Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Born in 2009-2010 Monthly telephone contact Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Born in 2009-2010 Blood Test Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test. Born in 2009-2010 Visits to the study site Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test.
- Primary Outcome Measures
Name Time Method Airway reactivity 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.
- Secondary Outcome Measures
Name Time Method skin tests for inhaled allergens Between the 3 to 4 years-of-age Respiratory morbidity every month 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.
IgE Between the 3 to 4 years-of-age in pereferal Blood count
Eosinophil count Between the 3 to 4 years-of-age in pereferal Blood count
Trial Locations
- Locations (1)
Rambam Medical Center
🇮🇱Haifa, Israel