Infant, Premature Clinical Trial
Official title:
Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
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..
;
Observational Model: Case Control, Time Perspective: Prospective
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