Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)
NCT ID: NCT00670956
Last Updated: 2015-03-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
1 participants
INTERVENTIONAL
2008-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Active Study Group
STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
Betamethasone
12 mg intramuscularly x 2 doses 24 hours apart
Placebo Group
PLACEBO: IM x 2 doses 24 hours apart
Placebo
PLACEBO: IM x 2 doses 24 hours apart
Interventions
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Betamethasone
12 mg intramuscularly x 2 doses 24 hours apart
Placebo
PLACEBO: IM x 2 doses 24 hours apart
Eligibility Criteria
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Inclusion Criteria
* Maternal age \> 18 years of age
* Singleton pregnancy
* Normal chromosomes
* CCAM volume to head circumference ratio (CVR) \> 1.4
* No maternal medical/surgical contraindications
* No evidence of hydrops
* Not previously randomization
Exclusion Criteria
* Preterm labor
* Multiple congenital anomalies with CCAM
* Chromosomal anomaly with CCAM
* Multiple gestation pregnancy with CCAM
* Not willing to be randomized
* Unable or unwilling to return to UCSF for second dose of drug or placebo
* CVR \< 1.4
18 Years
FEMALE
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Children's Hospital of Philadelphia
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Timothy M Crombleholme, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Cincinnati
Douglas Wilson, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Hanmin Lee, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco Fetal Treatment Center
San Francisco, California, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Fetal Care Center of Cincinnati Children's Hospital
Fetal Treatment Center at the University of California, San Francisco
Other Identifiers
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10-03705
Identifier Type: -
Identifier Source: org_study_id
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