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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1
12 mg intramuscularly x 2 doses 24 hours apart
PLACEBO: IM x 2 doses 24 hours apart
University of California, San Francisco Fetal Treatment Center
San Francisco, California, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Incidence of Hydrops Fetalis
Time frame: Delivery, up to approximately 20 weeks post-enrollment
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.
Status of neonate survival 30 days after delivery
Time frame: 30 days after delivery (up to approximately 24 weeks post-enrollment)
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