Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 30-32 Weeks of Gestation
Recruitment status was Not yet recruiting
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Purpose
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) and inflammatory parameters in exhaled breath condensate (EBC) in children born at 30-32 weeks.
Secondary objective: to assess prospectively the effect of palivizumab on respiratory morbidity and allergy in children born at 30-32 weeks.
Inclusion criteria: premature babies 30-32 weeks of gestation born during 2008 and 2009.
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 and inflammatory mediators in exhaled breath condensate Secondary end points: Respiratory morbidity as assessed by questionnaire and telephone interviews. Additionally, IGE, eosinophil count, and skin tests will be evaluated.
Sample size: 74 participants; Group I - 37 premature babies at 30-32 weeks of gestation born during 2008 (before approval of Synagis for this group in Israel). Group II - 37 premature babies 30-32 weeks of gestation born during 2009 (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.
| Condition | Intervention |
|---|---|
|
Airway Hyperreactivity and Lower Respiratory Morbidity After Palivizumab in Premature Babies (30-32 Weeks) |
Other: Methacholine Challenge Test (MCT) Other: Exhaled breath condensate (EBC) Other: Monthly telephone contact Other: Visits to the study site Other: Allergic Skin Test Other: Blood Test |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
- Airway reactivity [ Time Frame: Between the 3 to 4 years-of-age ] [ Designated as safety issue: Yes ]As assessed by methacholine challenge test with determination of PC20 and inflammatory mediators in exhaled breath condensate.
- Respiratory morbidity [ Time Frame: every month ] [ Designated as safety issue: No ]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.
- IgE [ Time Frame: Between the 3 to 4 years-of-age ] [ Designated as safety issue: No ]in pereferal Blood count
- Eosinophil count [ Time Frame: Between the 3 to 4 years-of-age ] [ Designated as safety issue: No ]in pereferal Blood count
- skin tests for inhaled allergens [ Time Frame: Between the 3 to 4 years-of-age ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 74 |
| Study Start Date: | July 2011 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Born in 2008
premature babies born at 30-32 weeks in 2008 that did not receive Palivizumab
|
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: Exhaled breath condensate (EBC)
EBC is achieved by freezing the exhaled air with the use of special condensing devices. EBC contains a large number of mediators and there is emerging evidence that parameters obtained from EBC reflect changes in the level of airway lining fluid. EBC analysis is an objective method of assessing airway inflammation and may facilitate better understanding of the underlying pathophysiology and natural history of respiratory morbidity following RSV bronchiolitis. Increased levels of cysteinyl leukotrienes and 8-isoprostane and decreased gamma interferon have been described in EBC of children with asthma. The possible effect of Synagis administration on airway inflammation at 3-4 years-of-age as assessed by measuring inflammatory cytokines in EBC was not evaluated. 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: Allergic Skin Test
skin test for detecting allergic reactions for inhaled allergens
Other: Blood Test
For assessing IgE levels and Eosinophils count
|
|
Born in 2009
premature babies born at 30-32 weeks in 2008 that received Palivizumab
|
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: Exhaled breath condensate (EBC)
EBC is achieved by freezing the exhaled air with the use of special condensing devices. EBC contains a large number of mediators and there is emerging evidence that parameters obtained from EBC reflect changes in the level of airway lining fluid. EBC analysis is an objective method of assessing airway inflammation and may facilitate better understanding of the underlying pathophysiology and natural history of respiratory morbidity following RSV bronchiolitis. Increased levels of cysteinyl leukotrienes and 8-isoprostane and decreased gamma interferon have been described in EBC of children with asthma. The possible effect of Synagis administration on airway inflammation at 3-4 years-of-age as assessed by measuring inflammatory cytokines in EBC was not evaluated. 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: Allergic Skin Test
skin test for detecting allergic reactions for inhaled allergens
Other: Blood Test
For assessing IgE levels and Eosinophils count
|
Eligibility| Ages Eligible for Study: | 3 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Premature babies 30-32 weeks of gestation born during 2008 and 2009
Inclusion Criteria:
- Premature babies 30-32 weeks of gestation born during 2008 and 2009
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
Contacts and Locations| Contact: Lea Bentur, Prof. | 972 854 3263 | l_bentur@rambam.health.gov.il |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 32000 | |
More Information
No publications provided
| Responsible Party: | Prof. Lea Bentur, Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT01269528 History of Changes |
| Other Study ID Numbers: | Evaluation of Palivizumab |
| Study First Received: | January 3, 2011 |
| Last Updated: | May 29, 2011 |
| Health Authority: | ISRAEL: Rambam Health Care Campus |
Keywords provided by Rambam Health Care Campus:
|
Palivizumab Airway Hyperreactivity EBC MCT |
Additional relevant MeSH terms:
|
Methacholine Chloride Palivizumab Miotics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Parasympathomimetics Bronchoconstrictor Agents |
Respiratory System Agents Therapeutic Uses Muscarinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013