Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01269528
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2011-01-03
Brief Title:
Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 05 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 Fishers exact test for categorical variables
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 eg 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 05 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 Fishers 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 eg 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 05 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 Fishers exact test for categorical variables
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 eg 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 05 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 Fishers exact test for categorical variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None