Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)
Status:
Terminated
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
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
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Children's Hospital Medical Center, Cincinnati Children's Hospital of Philadelphia