Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM) (CCAM Steroids)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Cystic Adenomatoid Malformation |
Drug: Betamethasone Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs |
- Incidence of hydrops fetalis between study and control groups [ Time Frame: Delivery ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 74 |
| Study Start Date: | April 2008 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active Study Group
STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
|
Drug: Betamethasone
12 mg intramuscularly x 2 doses 24 hours apart
|
|
Placebo Comparator: Placebo Group
PLACEBO: IM x 2 doses 24 hours apart
|
Drug: Placebo
PLACEBO: IM x 2 doses 24 hours apart
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| University of California, San Francisco Fetal Treatment Center | |
| San Francisco, California, United States, 94143 | |
| United States, Ohio | |
| Cincinnati Children's Hospital | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00670956 History of Changes |
| Other Study ID Numbers: | 10-03705 |
| Study First Received: | April 30, 2008 |
| Last Updated: | September 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
prenatal steroids hydrops congenital cystic adenomatoid malformation of the lung |
prenatal intervention betamethasone prenatal diagnosis |
Additional relevant MeSH terms:
|
Congenital Abnormalities Cystic Adenomatoid Malformation of Lung, Congenital Lung Diseases Respiratory Tract Diseases Respiratory System Abnormalities Betamethasone-17,21-dipropionate Betamethasone Betamethasone sodium phosphate Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013