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Trial record 1 of 1 for:    NCT01269528
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Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 30-32 Weeks of Gestation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01269528
First received: January 3, 2011
Last updated: June 10, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.

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: 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.

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: 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
Study Population

Premature babies 30-32 weeks of gestation born during 2008 and 2009

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269528

Contacts
Contact: Lea Bentur, Prof. 972 854 3263 l_bentur@rambam.health.gov.il

Locations
Israel
Rambam Medical Center
Haifa, Israel, 32000
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: 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: June 10, 2013
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
Anti-Infective Agents
Antiviral Agents
Autonomic Agents
Bronchoconstrictor Agents
Cholinergic Agents
Cholinergic Agonists
Miotics
Molecular Mechanisms of Pharmacological Action
Muscarinic Agonists
Neurotransmitter Agents
Parasympathomimetics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014