Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT00005294
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developmental Sequelae of Severe Chronic Lung Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1989-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-04', 'completionDateStruct': {'date': '1995-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2000-05-25', 'studyFirstSubmitQcDate': '2000-05-25', 'lastUpdatePostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-05-26', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Bronchopulmonary Dysplasia', 'Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '9374570', 'type': 'BACKGROUND', 'citation': 'Singer L, Yamashita T, Lilien L, Collin M, Baley J. A longitudinal study of developmental outcome of infants with bronchopulmonary dysplasia and very low birth weight. Pediatrics. 1997 Dec;100(6):987-93. doi: 10.1542/peds.100.6.987.'}, {'pmid': '1518692', 'type': 'BACKGROUND', 'citation': 'Singer L, Martin RJ, Hawkins SW, Benson-Szekely LJ, Yamashita TS, Carlo WA. Oxygen desaturation complicates feeding in infants with bronchopulmonary dysplasia after discharge. Pediatrics. 1992 Sep;90(3):380-4.'}, {'pmid': '1382125', 'type': 'BACKGROUND', 'citation': 'Singer L, Farkas K, Kliegman R. Childhood medical and behavioral consequences of maternal cocaine use. J Pediatr Psychol. 1992 Aug;17(4):389-406. doi: 10.1093/jpepsy/17.4.389.'}, {'pmid': '1400116', 'type': 'BACKGROUND', 'citation': 'Singer LT, Ambuel B, Wade S, Jaffe AC. Cognitive-behavioral treatment of health-impairing food phobias in children. J Am Acad Child Adolesc Psychiatry. 1992 Sep;31(5):847-52. doi: 10.1097/00004583-199209000-00011.'}, {'pmid': '1722034', 'type': 'BACKGROUND', 'citation': 'Singer LT, Hill BP, Orlowski JP, Doershuk CF. Medical and social factors as predictors of outcome in infant tracheostomy. Pediatr Pulmonol. 1991;11(3):243-8. doi: 10.1002/ppul.1950110310.'}, {'pmid': '1919905', 'type': 'BACKGROUND', 'citation': 'Singer LT, Garber R, Kliegman R. Neurobehavioral sequelae of fetal cocaine exposure. J Pediatr. 1991 Oct;119(4):667-72. doi: 10.1016/s0022-3476(05)82426-6.'}, {'pmid': '2045484', 'type': 'BACKGROUND', 'citation': 'Singer LT, Nofer JA, Benson-Szekely LJ, Brooks LJ. Behavioral assessment and management of food refusal in children with cystic fibrosis. J Dev Behav Pediatr. 1991 Apr;12(2):115-20.'}, {'pmid': '7513757', 'type': 'BACKGROUND', 'citation': 'Singer LT, Yamashita TS, Hawkins S, Cairns D, Baley J, Kliegman R. Increased incidence of intraventricular hemorrhage and developmental delay in cocaine-exposed, very low birth weight infants. J Pediatr. 1994 May;124(5 Pt 1):765-71. doi: 10.1016/s0022-3476(05)81372-1.'}, {'pmid': '8458168', 'type': 'BACKGROUND', 'citation': 'Singer L, Arendt R, Minnes S. Neurodevelopmental effects of cocaine. Clin Perinatol. 1993 Mar;20(1):245-62.'}, {'pmid': '8075743', 'type': 'BACKGROUND', 'citation': 'Singer L, Arendt R, Song LY, Warshawsky E, Kliegman R. Direct and indirect interactions of cocaine with childbirth outcomes. Arch Pediatr Adolesc Med. 1994 Sep;148(9):959-64. doi: 10.1001/archpedi.1994.02170090073014.'}, {'pmid': '8727839', 'type': 'BACKGROUND', 'citation': 'Singer LT, Davillier M, Preuss L, Szekely L, Hawkins S, Yamashita T, Baley J. Feeding interactions in infants with very low birth weight and bronchopulmonary dysplasia. J Dev Behav Pediatr. 1996 Apr;17(2):69-76.'}]}, 'descriptionModule': {'briefSummary': 'To determine the impact of bronchopulmonary dysplasia (BPD) on childhood development, family functioning, and parental stress.', 'detailedDescription': 'BACKGROUND:\n\nBronchopulmonary dysplasia in infancy has been shown to be related to less optimal physical and psychological functioning later in life. Although infants with the disorder increased from 1978 to 1988, little was known about potential developmental problems early in life which might lead to the documented negative sequelae shown in previous research.\n\nDESIGN NARRATIVE:\n\nIn this longitudinal study, infants were followed from birth and given standardized assessments of developmental and physical functioning. Demographic, birth, and medical data were collected at baseline through chart review. Standardized questionnaires measuring parental stress and family support were administered to the parents. Infants were followed at eight months, and one, two, and three years at which time parental measures were repeated and standardized assessments made of the children\'s physical growth, medical status, cognitive, language and behavioral development. Feeding behaviors were assessed through standardized observation and interview at each visit. Data were evaluated descriptively as well as through a series of multivariate analyses of variance with repeated measures.\n\nThe study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'No eligibility criteria'}, 'identificationModule': {'nctId': 'NCT00005294', 'briefTitle': 'Developmental Sequelae of Severe Chronic Lung Disorders', 'organization': {'class': 'NIH', 'fullName': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'orgStudyIdInfo': {'id': '2017'}, 'secondaryIdInfos': [{'id': 'R01HL038193', 'link': 'https://reporter.nih.gov/quickSearch/R01HL038193', 'type': 'NIH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}}}}