Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-04 @ 10:23 PM
Study NCT ID:
NCT00676351
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2008-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow up of Ventilatory Function in Infant After Bronchiolitis During the First Year of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001988', 'term': 'Bronchiolitis'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2008-05-12', 'studyFirstSubmitQcDate': '2008-05-12', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body plethysmography at least three weeks after the first bronchiolitis episode and at 18 and 24 months', 'timeFrame': '18, 24, 30 and 36 months'}, {'measure': 'Respiratory resistances measure (oscillometry and occlusion systems) at 30 and 36 months', 'timeFrame': '18, 24, 30 and 36 months'}], 'secondaryOutcomes': [{'measure': 'Skin prick tests', 'timeFrame': 'at the first exam, and at 24 and 36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '2729259', 'type': 'BACKGROUND', 'citation': "Wright AL, Taussig LM, Ray CG, Harrison HR, Holberg CJ. The Tucson Children's Respiratory Study. II. Lower respiratory tract illness in the first year of life. Am J Epidemiol. 1989 Jun;129(6):1232-46. doi: 10.1093/oxfordjournals.aje.a115243."}, {'pmid': '15516534', 'type': 'BACKGROUND', 'citation': 'Sigurs N, Gustafsson PM, Bjarnason R, Lundberg F, Schmidt S, Sigurbergsson F, Kjellman B. Severe respiratory syncytial virus bronchiolitis in infancy and asthma and allergy at age 13. Am J Respir Crit Care Med. 2005 Jan 15;171(2):137-41. doi: 10.1164/rccm.200406-730OC. Epub 2004 Oct 29.'}, {'pmid': '10094451', 'type': 'BACKGROUND', 'citation': 'Van Bever HP, Wieringa MH, Weyler JJ, Nelen VJ, Fortuin M, Vermeire PA. Croup and recurrent croup: their association with asthma and allergy. An epidemiological study on 5-8-year-old children. Eur J Pediatr. 1999 Mar;158(3):253-7. doi: 10.1007/s004310051062.'}, {'pmid': '12449185', 'type': 'BACKGROUND', 'citation': 'Schauer U, Hoffjan S, Bittscheidt J, Kochling A, Hemmis S, Bongartz S, Stephan V. RSV bronchiolitis and risk of wheeze and allergic sensitisation in the first year of life. Eur Respir J. 2002 Nov;20(5):1277-83. doi: 10.1183/09031936.02.00019902.'}, {'pmid': '10470697', 'type': 'BACKGROUND', 'citation': 'Stein RT, Sherrill D, Morgan WJ, Holberg CJ, Halonen M, Taussig LM, Wright AL, Martinez FD. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet. 1999 Aug 14;354(9178):541-5. doi: 10.1016/S0140-6736(98)10321-5.'}, {'pmid': '6547461', 'type': 'BACKGROUND', 'citation': 'Sampson HA, Albergo R. Comparison of results of skin tests, RAST, and double-blind, placebo-controlled food challenges in children with atopic dermatitis. J Allergy Clin Immunol. 1984 Jul;74(1):26-33. doi: 10.1016/0091-6749(84)90083-6.'}]}, 'descriptionModule': {'briefSummary': 'A significant proportion of asthma is diagnosed during childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life and the present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function testing.\n\nTwenty nine infants (8 females and 21 males) were included in our study. The beginning of the study started at least three weeks after the first bronchiolitis episode. Pulmonary function test was realized using an infant specific body plethysmography (Babybody, Erich Jaeger, Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using oscillometry and occlusion systems (Masterlab-IOS, Erich Jaeger, Germany). If measured data showed an obstruction, a bronchodilatator was inhaled to assess reversibility. When results were normal, a bronchial provocation test, using inhaled metacholine, was performed.\n\nSkin prick tests (SPTs) were performed during the first exam, and at 24 and 36 months (Stallergenes-DHS).\n\nCollection of data was largely incomplete due to a number of patients lost of follow up. Based on the available data, it can be conclude that most of lung tests results were in the normal range but a non negligible bronchial hyper reactivity was documented (41% of patients).\n\nThis study must be continued to increase the number of included patients and to continue their follow up during a longer time.', 'detailedDescription': 'Asthma affects a large population throughout the world and about two millions of persons in France, killing two hundred patients by year. A significant proportion of cases of asthma are diagnosed during childhood. Understanding the relation between early-life infectious exposures and asthma and atopy appears to be considerable interest.\n\nRespiratory infectious illnesses, mostly viral, are very common in childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life (1). It is commonly caused by respiratory syncytial virus (RSV) and is often associated with subsequent wheezing and childhood asthma (2). Respiratory infectious illnesses caused by other agent than RSV can be also associated with asthma and atopy (3). However, the relation between respiratory infectious illnesses in early life and asthma in childhood is again much debated since some studies show a relationship between bronchiolitis and atopy (4) but not others (5, 6).\n\nThe present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function testing.\n\nTwenty nine infants (8 females and 21 males) were included in our study and 8 of 29 infants were of premature birth. The youngest patient was 3 months old and the older fourteen months old. The beginning of the study started at least three weeks after the first bronchiolitis episode. Pulmonary function test was realized using body plethysmography (Babybody, Erich Jaeger, Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system (Masterlab-IOS, Erich Jaeger, Germany). All respiratory tests were performed on patients in asymptomatic respiratory condition and at least one month apart from respiratory infection. If measured data showed an obstruction, a bronchodilator was inhaled to assess reversibility. When results were normal, a bronchial provocation test, using inhaled metacholine, was performed.\n\nSkin prick tests (SPTs) were performed at the first exam, and at 24 and 36 months (Stallergenes-DHS). Dermatophagoides pteronyssinus, alternaria, cat dander, cockroach, orchard grass and timothy grass were systematically tested. The SPTs were considered positive when the wheal diameter was over 3 mm and 50% larger than the positive control, and the negative control remained negative (7). The possibility of dermographism was eliminated by a negative reaction of the negative control.\n\nCollection of data was largely incomplete due to a number of patients lost of follow up. Briefly, based on the available data, most of lung tests results were in the normal range although a proportion of patients experienced recurrent wheezing episodes during follow up. Nevertheless a bronchial hyper reactivity to metacholine was documented in 41%. Atopy, as screened by SPTs, was detected in a minority of infants (13.5%). Coexistence of bronchial hyper reactivity and atopy was present in only one patient.\n\nThese incomplete results highlight the complex interplay between symptoms, bronchial obstruction, bronchial hyper reactivity and atopy in the subsequent development of asthma in wheezy children. Long term follow up is necessary to assess the prognostic value of these parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* child under 32 months old\n* child suffering from bronchiolitis episode at least 3 weeks before beginning the study\n\nExclusion Criteria:\n\n* child over 32 months old\n* child suffering from bronchiolitis episode since less than 3 weeks'}, 'identificationModule': {'nctId': 'NCT00676351', 'briefTitle': 'Follow up of Ventilatory Function in Infant After Bronchiolitis During the First Year of Life', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Follow up of Ventilatory Function in Infant After One (or More) Bronchiolitis During the First Year of Life. Course Towards Asthma', 'orgStudyIdInfo': {'id': '02-PHRC-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'body plethysmography Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system', 'interventionNames': ['Procedure: body plethysmography']}], 'interventions': [{'name': 'body plethysmography', 'type': 'PROCEDURE', 'description': 'Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using an oscillometry system and an occlusion system', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'CRENESSE Dominique', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Dominique CRENESSE, PU PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cynthia GIRAN', 'oldOrganization': "Département de la recherche Clinique et de l'Innovation - CHU de Nice"}}}}