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Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM) (CCAM Steroids)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00670956
Recruitment Status : Terminated (Recruitment has been poor. Study drug is being offered as part of standard care of women carrying a pregnancy diagnosed with CCAM)
First Posted : May 2, 2008
Results First Posted : March 30, 2015
Last Update Posted : March 30, 2015
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Congenital Cystic Adenomatoid Malformation
Interventions Drug: Betamethasone
Drug: Placebo
Enrollment 1
Recruitment Details Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm
Pre-assignment Details  
Arm/Group Title Active Study Group
Hide Arm/Group Description

STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart

Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Active Study Group
Hide Arm/Group Description

STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart

Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Incidence of Hydrops Fetalis
Hide Description [Not Specified]
Time Frame Delivery, up to approximately 20 weeks post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm
Arm/Group Title Active Study Group
Hide Arm/Group Description:

STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart

Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)
Hide Description [Not Specified]
Time Frame Baseline, Delivery (up to approximately 20 weeks post-enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated without enrollment to control arm; therefore, no comparison was made
Arm/Group Title Active Study Group
Hide Arm/Group Description:

STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart

Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Survival at One-month Between Study and Control Groups.
Hide Description Status of neonate survival 30 days after delivery
Time Frame 30 days after delivery (up to approximately 24 weeks post-enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Study Group
Hide Arm/Group Description:

STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart

Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart

Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
1
Time Frame 30 days post-delivery (up to approximately 24 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Study Group
Hide Arm/Group Description

STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart

Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart

All-Cause Mortality
Active Study Group
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Active Study Group
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Study Group
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hanmin Lee, MD
Organization: University of California San Francisco
Phone: 415-476-4086
EMail: hanmin.lee@ucsf.edu
Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00670956    
Other Study ID Numbers: 10-03705
First Submitted: April 30, 2008
First Posted: May 2, 2008
Results First Submitted: March 18, 2015
Results First Posted: March 30, 2015
Last Update Posted: March 30, 2015