Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 30, 2008
First Posted Date  ICMJE May 2, 2008
Results First Submitted Date  ICMJE March 18, 2015
Results First Posted Date  ICMJE March 30, 2015
Last Update Posted Date March 30, 2015
Study Start Date  ICMJE April 2008
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
Incidence of Hydrops Fetalis [ Time Frame: Delivery, up to approximately 20 weeks post-enrollment ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 1, 2008)
Incidence of hydrops fetalis between study and control groups [ Time Frame: Delivery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2015)
  • Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo) [ Time Frame: Baseline, Delivery (up to approximately 20 weeks post-enrollment) ]
  • Survival at One-month Between Study and Control Groups. [ Time Frame: 30 days after delivery (up to approximately 24 weeks post-enrollment) ]
    Status of neonate survival 30 days after delivery
Original Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2008)
Effect of maternal steroid (betamethasone) administration on CCAM size in mid-trimester fetuses (study/administration vs control/placebo); and compare survival at one-month between study and control groups. [ Time Frame: To delivery and 30 days post-delivery, respectively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)
Official Title  ICMJE Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs
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 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Congenital Cystic Adenomatoid Malformation
Intervention  ICMJE
  • Drug: Betamethasone
    12 mg intramuscularly x 2 doses 24 hours apart
  • Drug: Placebo
    PLACEBO: IM x 2 doses 24 hours apart
Study Arms  ICMJE
  • Active Comparator: Active Study Group
    STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
    Intervention: Drug: Betamethasone
  • Placebo Comparator: Placebo Group
    PLACEBO: IM x 2 doses 24 hours apart
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 18, 2015)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2008)
74
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00670956
Other Study ID Numbers  ICMJE 10-03705
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • Children's Hospital Medical Center, Cincinnati
  • Children's Hospital of Philadelphia
Investigators  ICMJE
Principal Investigator: Timothy M Crombleholme, MD Children's Hospital of Cincinnati
Principal Investigator: Douglas Wilson, MD Children's Hospital of Philadelphia
Principal Investigator: Hanmin Lee, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP