Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-23 @ 12:07 PM
Study NCT ID:
NCT00322660
Status:
COMPLETED
Last Update Posted:
2007-06-28
First Post:
2006-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adrenaline Injections to Children Born at Elective CS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-27', 'studyFirstSubmitDate': '2006-05-05', 'studyFirstSubmitQcDate': '2006-05-05', 'lastUpdatePostDateStruct': {'date': '2007-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'respiratory distress'}, {'measure': 'hypoglycemia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Respiratory Distress', 'Hypoglycemia']}, 'referencesModule': {'references': [{'pmid': '6587720', 'type': 'BACKGROUND', 'citation': 'Irestedt L, Lagercrantz H, Belfrage P. Causes and consequences of maternal and fetal sympathoadrenal activation during parturition. Acta Obstet Gynecol Scand Suppl. 1984;118:111-5. doi: 10.3109/00016348409157136.'}, {'pmid': '18786961', 'type': 'DERIVED', 'citation': 'Pedersen P, Avlund OL, Pedersen BL, Pryds O. Intramuscular adrenaline does not reduce the incidence of respiratory distress and hypoglycaemia in neonates delivered by elective caesarean section at term. Arch Dis Child Fetal Neonatal Ed. 2009 May;94(3):F164-7. doi: 10.1136/adc.2008.138487. Epub 2008 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'Children born after elective C-section have a greater risk of respiratory problems and hypoglycemia - most likely due to a lower concentration of stress hormones compared to children born vaginally. Hypothesis: can we eliminate or reduce the risk of respiratory distress and hypoglycaemia by administrating adrenaline to the newborn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children born at elective section with gestational age more than 37 + 0\n\nExclusion Criteria:\n\n* Children in whom a serious malformation was found during pregnancy assuming this malformation will lead to very early death or respiratory problems.\n* Serious malformations (ex.anencephalia) will be excluded at birth\n* Other malformations will be estimated by investigator whether it will lead to exclusion.'}, 'identificationModule': {'nctId': 'NCT00322660', 'briefTitle': 'Adrenaline Injections to Children Born at Elective CS', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline', 'orgStudyIdInfo': {'id': '2005091'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adrenaline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Copenhagen', 'state': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2650', 'city': 'Kettegård Alle 31', 'state': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre Hospital'}], 'overallOfficials': [{'name': 'Lene A Olsen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital, Copenhagen, Kettegaards allé 30, 2650 Hvidovre, DK'}, {'name': 'Pernille Pedersen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}}}}