Conditions: Congenital Cystic Adenomatoid Malformation
Keywords: prenatal steroids hydrops congenital cystic adenomatoid malformation of the lung prenatal intervention betamethasone prenatal diagnosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: yes

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 description:

Arms:
arm 1: STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart arm 2: PLACEBO: IM x 2 doses 24 hours apart

Interventions: intervention 1: Betamethasone intervention 2: Placebo
Intervention descriptions: intervention 1: 12 mg intramuscularly x 2 doses 24 hours apart intervention 2: PLACEBO: IM x 2 doses 24 hours apart

Protocol document: