NCT01269528

Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

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..

Conditions

• Bronchial Hyperreactivity
• Infant, Premature

Interventions

Type	Name	Description
OTHER	Methacholine Challenge Test (MCT)	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.
OTHER	Monthly telephone contact	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.
OTHER	Visits to the study site	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.
OTHER	Blood Test	For assessing IgE levels, Eosinophils count and cytokines levels
OTHER	Fractional exhaled nitric oxide	Participant blow tidal volume for determination of exhaled NO in Exhaled breath.

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2011-01-04
• Last updated: 2015-11-10

Locations

1 site across 1 country: Israel