Trial record 1 of 1 for:    NCT01269528
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Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01269528
First received: January 3, 2011
Last updated: November 8, 2015
Last verified: November 2015
  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) 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.


Condition Intervention
Bronchial Hyperreactivity
Infant, Premature
Other: Methacholine Challenge Test (MCT)
Other: Monthly telephone contact
Other: Visits to the study site
Other: Blood Test
Other: Fractional exhaled nitric oxide

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation

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 ]

Biospecimen Retention:   Samples Without DNA
Whole blood for complete blood count , IGE and cytokines.

Enrollment: 42
Study Start Date: August 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Born in 2007-2008
Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test.
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.
Born in 2009-2010
Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test.
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.

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

Ages Eligible for Study:   4 Years to 7 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature babies 29-32 weeks of gestation born during 2007 and 2010
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
  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

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

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: November 8, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Palivizumab
Airway Hyperreactivity
EBC
MCT

Additional relevant MeSH terms:
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Nitric Oxide
Methacholine Chloride
Palivizumab
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents
Miotics
Parasympathomimetics
Bronchoconstrictor Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 30, 2016