Clinical Trial: Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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 Summary:
Sponsor: University of California, San Francisco
Current Primary Outcome: Incidence of Hydrops Fetalis [ Time Frame: Delivery, up to approximately 20 weeks post-enrollment ]
Original Primary Outcome: Incidence of hydrops fetalis between study and control groups [ Time Frame: Delivery ]
Current Secondary Outcome:
- 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: 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 ]
Information By: University of California, San Francisco
Dates:
Date Received: April 30, 2008
Date Started: April 2008
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015
