Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-02 @ 9:47 AM
Study NCT ID:
NCT00670956
Status:
TERMINATED
Last Update Posted:
2015-03-30
First Post:
2008-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015615', 'term': 'Cystic Adenomatoid Malformation of Lung, Congenital'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015619', 'term': 'Respiratory System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001623', 'term': 'Betamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hanmin.lee@ucsf.edu', 'phone': '415-476-4086', 'title': 'Hanmin Lee, MD', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days post-delivery (up to approximately 24 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Active Study Group', 'description': 'STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart\n\nBetamethasone: 12 mg intramuscularly x 2 doses 24 hours apart', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Hydrops Fetalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Study Group', 'description': 'STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart\n\nBetamethasone: 12 mg intramuscularly x 2 doses 24 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery, up to approximately 20 weeks post-enrollment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm'}, {'type': 'SECONDARY', 'title': 'Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Study Group', 'description': 'STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart\n\nBetamethasone: 12 mg intramuscularly x 2 doses 24 hours apart'}], 'timeFrame': 'Baseline, Delivery (up to approximately 20 weeks post-enrollment)', 'reportingStatus': 'POSTED', 'populationDescription': 'Study was terminated without enrollment to control arm; therefore, no comparison was made'}, {'type': 'SECONDARY', 'title': 'Survival at One-month Between Study and Control Groups.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Study Group', 'description': 'STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart\n\nBetamethasone: 12 mg intramuscularly x 2 doses 24 hours apart'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after delivery (up to approximately 24 weeks post-enrollment)', 'description': 'Status of neonate survival 30 days after delivery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Study Group', 'description': 'STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart\n\nBetamethasone: 12 mg intramuscularly x 2 doses 24 hours apart'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Study Group', 'description': 'STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart\n\nBetamethasone: 12 mg intramuscularly x 2 doses 24 hours apart'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Recruitment has been poor. Study drug is being offered as part of standard care of women carrying a pregnancy diagnosed with CCAM', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2008-04-30', 'resultsFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2008-05-01', 'lastUpdatePostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-18', 'studyFirstPostDateStruct': {'date': '2008-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Hydrops Fetalis', 'timeFrame': 'Delivery, up to approximately 20 weeks post-enrollment'}], 'secondaryOutcomes': [{'measure': 'Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)', 'timeFrame': 'Baseline, Delivery (up to approximately 20 weeks post-enrollment)'}, {'measure': 'Survival at One-month Between Study and Control Groups.', 'timeFrame': '30 days after delivery (up to approximately 24 weeks post-enrollment)', 'description': 'Status of neonate survival 30 days after delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prenatal steroids', 'hydrops', 'congenital cystic adenomatoid malformation of the lung', 'prenatal intervention', 'betamethasone', 'prenatal diagnosis'], 'conditions': ['Congenital Cystic Adenomatoid Malformation']}, 'referencesModule': {'references': [{'pmid': '17706495', 'type': 'BACKGROUND', 'citation': 'Vu L, Tsao K, Lee H, Nobuhara K, Farmer D, Harrison M, Goldstein RB. Characteristics of congenital cystic adenomatoid malformations associated with nonimmune hydrops and outcome. J Pediatr Surg. 2007 Aug;42(8):1351-6. doi: 10.1016/j.jpedsurg.2007.03.039.'}, {'pmid': '17099841', 'type': 'BACKGROUND', 'citation': 'Schumacher A, Sidor J, Buhling KJ. [Continuous glucose monitoring using the glucose sensor CGMS in metabolically normal pregnant women during betamethasone therapy for fetal respiratory distress syndrome]. Z Geburtshilfe Neonatol. 2006 Oct;210(5):184-90. doi: 10.1055/s-2006-951743. German.'}, {'pmid': '17272618', 'type': 'BACKGROUND', 'citation': 'Peltoniemi OM, Kari MA, Tammela O, Lehtonen L, Marttila R, Halmesmaki E, Jouppila P, Hallman M; Repeat Antenatal Betamethasone Study Group. Randomized trial of a single repeat dose of prenatal betamethasone treatment in imminent preterm birth. Pediatrics. 2007 Feb;119(2):290-8. doi: 10.1542/peds.2006-1549.'}, {'pmid': '16856047', 'type': 'BACKGROUND', 'citation': 'Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004454. doi: 10.1002/14651858.CD004454.pub2.'}, {'pmid': '17233108', 'type': 'BACKGROUND', 'citation': 'Neilson JP. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Obstet Gynecol. 2007 Jan;109(1):189-90. doi: 10.1097/01.aog.0000251610.51286.b1. No abstract available.'}, {'pmid': '12632377', 'type': 'BACKGROUND', 'citation': 'Tsao K, Hawgood S, Vu L, Hirose S, Sydorak R, Albanese CT, Farmer DL, Harrison MR, Lee H. Resolution of hydrops fetalis in congenital cystic adenomatoid malformation after prenatal steroid therapy. J Pediatr Surg. 2003 Mar;38(3):508-10. doi: 10.1053/jpsu.2003.50089.'}, {'pmid': '15325542', 'type': 'BACKGROUND', 'citation': 'Arca MJ, Teich S. Current controversies in perinatal care: fetal versus neonatal surgery. Clin Perinatol. 2004 Sep;31(3):629-48. doi: 10.1016/j.clp.2004.03.016.'}, {'pmid': '15305098', 'type': 'BACKGROUND', 'citation': 'Wilson RD, Baxter JK, Johnson MP, King M, Kasperski S, Crombleholme TM, Flake AW, Hedrick HL, Howell LJ, Adzick NS. Thoracoamniotic shunts: fetal treatment of pleural effusions and congenital cystic adenomatoid malformations. Fetal Diagn Ther. 2004 Sep-Oct;19(5):413-20. doi: 10.1159/000078994.'}, {'pmid': '17001747', 'type': 'BACKGROUND', 'citation': 'Knox EM, Kilby MD, Martin WL, Khan KS. In-utero pulmonary drainage in the management of primary hydrothorax and congenital cystic lung lesion: a systematic review. Ultrasound Obstet Gynecol. 2006 Oct;28(5):726-34. doi: 10.1002/uog.3812.'}, {'pmid': '15065026', 'type': 'BACKGROUND', 'citation': 'Davenport M, Warne SA, Cacciaguerra S, Patel S, Greenough A, Nicolaides K. Current outcome of antenally diagnosed cystic lung disease. J Pediatr Surg. 2004 Apr;39(4):549-56. doi: 10.1016/j.jpedsurg.2003.12.021.'}, {'pmid': '8783108', 'type': 'BACKGROUND', 'citation': 'Miller JA, Corteville JE, Langer JC. Congenital cystic adenomatoid malformation in the fetus: natural history and predictors of outcome. J Pediatr Surg. 1996 Jun;31(6):805-8. doi: 10.1016/s0022-3468(96)90138-4.'}], 'seeAlsoLinks': [{'url': 'http://www.fetalcarecenter.org/', 'label': "Fetal Care Center of Cincinnati Children's Hospital"}, {'url': 'http://fetus.ucsfmedicalcenter.org/', 'label': 'Fetal Treatment Center at the University of California, San Francisco'}]}, 'descriptionModule': {'briefSummary': 'Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung tissue. Administration of maternal steroids in the mid-trimester may stop the growth or decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in fetuses with large CCAMs. This is a prospective, blinded, randomized trial comparing administration of a single course of antenatal steroids (Betamethasone) to control (i.e., placebo). The primary outcome variable will be incidence of hydrops. One month postnatal survival and relative size of the CCAM as determined by CCAM volume:head circumference ratio (CVR) between treatment/no treatment groups will be secondary outcome variables. Change in size of CCAM will be serially followed for both groups with individual growth curves being plotted prenatally and these will be compared with pathology weigh and volume to evaluate treatment effect. Other prenatal data collected will include: incidence of polyhydramnios, incidence of premature rupture of membranes, incidence of material complications. We will also compare mode of delivery, postnatal respiratory compromise, need for resection in the first week of life, and occurrence of complications during newborn administration'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GA \\< 26 weeks\n* Maternal age \\> 18 years of age\n* Singleton pregnancy\n* Normal chromosomes\n* CCAM volume to head circumference ratio (CVR) \\> 1.4\n* No maternal medical/surgical contraindications\n* No evidence of hydrops\n* Not previously randomization\n\nExclusion Criteria:\n\n* Maternal diabetes or use of insulin\n* Preterm labor\n* Multiple congenital anomalies with CCAM\n* Chromosomal anomaly with CCAM\n* Multiple gestation pregnancy with CCAM\n* Not willing to be randomized\n* Unable or unwilling to return to UCSF for second dose of drug or placebo\n* CVR \\< 1.4'}, 'identificationModule': {'nctId': 'NCT00670956', 'acronym': 'CCAM Steroids', 'briefTitle': 'Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs', 'orgStudyIdInfo': {'id': '10-03705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Study Group', 'description': 'STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart', 'interventionNames': ['Drug: Betamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'PLACEBO: IM x 2 doses 24 hours apart', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Betamethasone', 'type': 'DRUG', 'description': '12 mg intramuscularly x 2 doses 24 hours apart', 'armGroupLabels': ['Active Study Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'PLACEBO: IM x 2 doses 24 hours apart', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco Fetal Treatment Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Timothy M Crombleholme, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Cincinnati"}, {'name': 'Douglas Wilson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}, {'name': 'Hanmin Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}