Congenital Cystic Adenomatoid Malformation Clinical Trial
— CCAM SteroidsOfficial title:
Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs
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
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | University of California, San Francisco Fetal Treatment Center | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, San Francisco | Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia |
United States,
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* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Hydrops Fetalis | Delivery, up to approximately 20 weeks post-enrollment | No | |
| Secondary | Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo) | Baseline, Delivery (up to approximately 20 weeks post-enrollment) | No | |
| Secondary | Survival at One-month Between Study and Control Groups. | Status of neonate survival 30 days after delivery | 30 days after delivery (up to approximately 24 weeks post-enrollment) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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