Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM) (CCAM Steroids)

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Congenital Cystic Adenomatoid Malformation

Treatments: Drug: Betamethasone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00670956

10-03705

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

Active Study Group

Active Comparator group

Description:

STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart

Treatment:

Drug: Betamethasone

Placebo Group

Placebo Comparator group

Description:

PLACEBO: IM x 2 doses 24 hours apart

Treatment:

Drug: Placebo