Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-01 @ 2:29 AM
Study NCT ID:
NCT00422305
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2007-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Lung Structure and Function of Infants Born Prematurely
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'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'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2007-01-11', 'studyFirstSubmitQcDate': '2007-01-11', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Function Testing', 'timeFrame': 'day of testing', 'description': 'Forced expiratory Flows, Single-breath diffusion capacity and alveolar volume'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infant, Premature', 'Bronchopulmonary dysplasia', 'asthma'], 'conditions': ['Premature Birth', 'Bronchopulmonary Dysplasia', 'Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the growth of the lung and how easily gas can be taken up by the lung in healthy infants born at full term without any breathing problems and infants born prematurely.', 'detailedDescription': 'SPECIFIC AIM #1:\n\nDetermine the relationship between parenchymal tissue and alveolar volume with normal lung growth early in life.\n\nWe hypothesize that during the first two years of life that parenchymal surface area and alveolar volume increase with somatic growth; however, the ratio of surface area to volume remains constant, while ventilation within the lung becomes more homogenous.\n\nSPECIFIC AIM #2:\n\nDetermine the pulmonary sequelae of premature birth and assess the effectiveness of early treatment strategies upon the pulmonary sequelae.\n\nWe hypothesize that premature birth impedes growth and development of the lung parenchyma and the airways. In addition, initiating continuous positive airway pressure (CPAP) and a permissive ventilatory strategy in very premature infants at birth will improve lung growth and lung function compared to treatment with early surfactant and conventional ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be selected from Infant Lung Disease Clinics at Riley Hospital, flyer in the community, and the neonatal intensive care unit (NICU) at Riley Hospial for Children, Indiana University and Methodist Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup 1:\n\n* 37 weeks or greater gestational age\n* Age 2 to 36 months\n\nGroup 2:\n\n* 37 weeks or greater gestational age having a CT scan for non-respiratory issues.\n* Age 2-36 months\n\nGroup 3:\n\n* 23-35 weeks gestational age\n\nExclusion Criteria:\n\nGroup 1 and Group 2:\n\n* Congenital cardio-respiratory disease\n* Hospitalization for respiratory illness\n* Treatment with asthma medications\n* Small for gestational age at birth\n\nGroup 3:\n\n* Congenital cardio-respiratory disease\n* Severe developmental delay'}, 'identificationModule': {'nctId': 'NCT00422305', 'briefTitle': 'Assessment of Lung Structure and Function of Infants Born Prematurely', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Assessment of Lung Structure and Function of Infants Born Prematurely', 'orgStudyIdInfo': {'id': '0603-15'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1-Healthy Infants', 'description': 'Group 1: The investigators will recruit 80 healthy infants born at \\> 37 weeks gestation, and between 2 and 36 months of age. Infants will be excluded for any of the following reasons:\n\n1. Congenital cardio-respiratory disease\n2. Hospitalization for respiratory illness\n3. Treatment with asthma medications\n4. Small for gestational age at birth'}, {'label': '2-Healthy Infants computerized Tomography', 'description': 'Group 2: The investigators recruited 4 infants born at \\> 37 weeks gestation and they were evaluated between 2 and 36 months of age when scheduled for high resolution computed tomography (HRCT) imaging for non-respiratory medical problems. Subjects were enrolled and HRCT of the chest were obtained. Infants were excluded for the following reasons:\n\n1. Congenital cardio-respiratory disease\n2. Hospitalization for respiratory illness\n3. Treatment with asthma medications'}, {'label': '3-Premature Infants', 'description': 'Group 3: The investigators have recruited 45 infants born prematurely at 23-35 weeks gestation. Subjects were evaluated at corrected age at between 2 and 24 months. The subjects had no oxygen requirements, and were clinically stable outpatients when evaluated. Infants were excluded for any of the following reasons:\n\n1. Congenital cardio-respiratory disease\n2. Severe developmental delay'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Robert S. Tepper, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Robert Tepper', 'investigatorFullName': 'Robert Tepper', 'investigatorAffiliation': 'Indiana University'}}}}