Clinical trial NCT01269528: Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
Official title: Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Hyperreactivity
Infant, Premature
Keywords: Palivizumab
Airway Hyperreactivity
EBC
MCT
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 42
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature babies 29-32 weeks of gestation born during 2007 and 2010

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..

Eligibility criteria: Inclusion Criteria:

* Premature babies 29-32 weeks of gestation born during 2007 and 2010

Exclusion Criteria:

* 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

Primary outcomes:
measure: Airway reactivity
timeFrame: Between the 3 to 4 years-of-age
Secondary outcomes:
measure: Respiratory morbidity
timeFrame: every month
measure: IgE
timeFrame: Between the 3 to 4 years-of-age
measure: Eosinophil count
timeFrame: Between the 3 to 4 years-of-age
measure: skin tests for inhaled allergens
timeFrame: Between the 3 to 4 years-of-age
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References: