Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2026-03-05 @ 9:11 PM
Study NCT ID:
NCT01269528
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2011-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016535', 'term': 'Bronchial Hyperreactivity'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood for complete blood count , IGE and cytokines.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-08', 'studyFirstSubmitDate': '2011-01-03', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway reactivity', 'timeFrame': 'Between the 3 to 4 years-of-age', 'description': 'As assessed by methacholine challenge test with determination of PC20 and inflammatory mediators in exhaled breath condensate.'}], 'secondaryOutcomes': [{'measure': 'Respiratory morbidity', 'timeFrame': 'every month', 'description': '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.'}, {'measure': 'IgE', 'timeFrame': 'Between the 3 to 4 years-of-age', 'description': 'in pereferal Blood count'}, {'measure': 'Eosinophil count', 'timeFrame': 'Between the 3 to 4 years-of-age', 'description': 'in pereferal Blood count'}, {'measure': 'skin tests for inhaled allergens', 'timeFrame': 'Between the 3 to 4 years-of-age'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Palivizumab', 'Airway Hyperreactivity', 'EBC', 'MCT'], 'conditions': ['Bronchial Hyperreactivity', 'Infant, Premature']}, 'descriptionModule': {'briefSummary': "Protocol Synopsis: There is a link between early RSV infection and chronic respiratory morbidity.\n\nHypothesis: Palivizumab administration may result in decreased AHR and lower respiratory morbidity.\n\nPrimary objective: to evaluate prospectively the effect of palivizumab on airway reactivity (AHR) in children born at 29-32 weeks.\n\nSecondary objective: to assess prospectively the effect of palivizumab on respiratory morbidity airway inflammation and allergy in children born at 29-32 weeks.\n\nInclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.\n\nExclusion 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.\n\nPrimary end points: Airway reactivity as assessed by methacholine challenge test with determination of PC20.\n\nSecondary end points: Respiratory morbidity as assessed by questionnaire and telephone interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.\n\nSample 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).\n\nStatistics: 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.", 'detailedDescription': "Protocol Synopsis: There is a link between early RSV infection and chronic respiratory morbidity.\n\nHypothesis: Palivizumab administration may result in decreased AHR and lower respiratory morbidity.\n\nPrimary objective: to evaluate prospectively the effect of palivizumab on airway reactivity (AHR) in children born at 29-32 weeks.\n\nSecondary objective: to assess prospectively the effect of palivizumab on respiratory morbidity airway inflammation and allergy in children born at 29-32 weeks.\n\nInclusion criteria: premature babies 29-32 weeks of gestation born during 2007 and 2010.\n\nExclusion 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.\n\nPrimary end points: Airway reactivity as assessed by methacholine challenge test with determination of PC20.\n\nSecondary end points: Respiratory morbidity as assessed by questionnaire and telephone interviews. Additionally, IGE, eosinophil count, and exhaled NO will be evaluated.\n\nSample 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).\n\nStatistics: 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.."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature babies 29-32 weeks of gestation born during 2007 and 2010', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature babies 29-32 weeks of gestation born during 2007 and 2010\n\nExclusion Criteria:\n\n* Any mechanical ventilation\n* Chronic diseases, e.g., bronchopulmonary dysplasia (BPD), cystic fibrosis (CF), congenital heart disease, congenital anomalies\n* Known immunodeficiency\n* Receipt of other RSV investigative vaccines or therapies'}, 'identificationModule': {'nctId': 'NCT01269528', 'briefTitle': 'Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Prospective Evaluation of the Efficacy of Palivizumab Administration in Children Born at 29-32 Weeks of Gestation', 'orgStudyIdInfo': {'id': 'Evaluation of Palivizumab'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Born in 2007-2008', 'description': 'Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test.', 'interventionNames': ['Other: Methacholine Challenge Test (MCT)', 'Other: Monthly telephone contact', 'Other: Visits to the study site', 'Other: Blood Test', 'Other: Fractional exhaled nitric oxide']}, {'label': 'Born in 2009-2010', 'description': 'Methacholine Challenge Test (MCT). Monthly telephone contact. Visits to the study site. Fractional exhaled nitric oxide. Blood test.', 'interventionNames': ['Other: Methacholine Challenge Test (MCT)', 'Other: Monthly telephone contact', 'Other: Visits to the study site', 'Other: Blood Test', 'Other: Fractional exhaled nitric oxide']}], 'interventions': [{'name': 'Methacholine Challenge Test (MCT)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Born in 2007-2008', 'Born in 2009-2010']}, {'name': 'Monthly telephone contact', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Born in 2007-2008', 'Born in 2009-2010']}, {'name': 'Visits to the study site', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Born in 2007-2008', 'Born in 2009-2010']}, {'name': 'Blood Test', 'type': 'OTHER', 'description': 'For assessing IgE levels, Eosinophils count and cytokines levels', 'armGroupLabels': ['Born in 2007-2008', 'Born in 2009-2010']}, {'name': 'Fractional exhaled nitric oxide', 'type': 'OTHER', 'description': 'Participant blow tidal volume for determination of exhaled NO in Exhaled breath.', 'armGroupLabels': ['Born in 2007-2008', 'Born in 2009-2010']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32000', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}