An observational study in Bronchial Hyperreactivity and Infant, Premature, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2015-11-10.
Sponsored by Rambam Health Care Campus · Observational
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.
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..
35 studies on the registry are indexed under Bronchial Hyperreactivity; 4 are open to participants now.
This study's enrollment of 42 is below the median of 50 across 15 observational studies indexed under Bronchial Hyperreactivity.
Browse Bronchial Hyperreactivity studies →Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.
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Premature babies 29-32 weeks of gestation born during 2007 and 2010
Exclusion Criteria:
Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test.
Other: Methacholine Challenge Test (MCT) · Other: Monthly telephone contact · Other: Visits to the study site · Other: Blood Test · Other: Fractional exhaled nitric oxide
Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test.
Other: Methacholine Challenge Test (MCT) · Other: Monthly telephone contact · Other: Visits to the study site · Other: Blood Test · Other: Fractional exhaled nitric oxide
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.
Airway reactivity
As assessed by methacholine challenge test with determination of PC20 and inflammatory mediators in exhaled breath condensate.
Time frame: Between the 3 to 4 years-of-age
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.
Time frame: every month
IgE
in pereferal Blood count
Time frame: Between the 3 to 4 years-of-age
Eosinophil count
in pereferal Blood 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
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Rambam Health Care Campus