Status:
TERMINATED
Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia
Conditions:
Congenital Cystic Adenomatoid Malformation
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- GA \< 26 weeks
- 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
- Maternal diabetes or use of insulin
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00670956
Start Date
April 1 2008
End Date
September 1 2011
Last Update
March 30 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco Fetal Treatment Center
San Francisco, California, United States, 94143
2
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229-3039
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104