Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congenital Cystic Adenomatoid Malformation
Intervention: Betamethasone (Drug); Placebo (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s): Timothy M Crombleholme, MD, Principal Investigator, Affiliation: Children's Hospital of Cincinnati Douglas Wilson, MD, Principal Investigator, Affiliation: Children's Hospital of Philadelphia Hanmin Lee, MD, Principal Investigator, Affiliation: University of California, San Francisco
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
Clinical Details
Official title: Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Incidence of Hydrops Fetalis
Secondary outcome: Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)Survival at One-month Between Study and Control Groups.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
University of California, San Francisco Fetal Treatment Center, San Francisco, California 94143, United States
Cincinnati Children's Hospital, Cincinnati, Ohio 45229-3039, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States
Additional Information
Fetal Care Center of Cincinnati Children's Hospital Fetal Treatment Center at the University of California, San Francisco Center for Fetal Diagnosis and Treatment, Children's Hospital of Philadelphia
Related publications: Vu L, Tsao K, Lee H, Nobuhara K, Farmer D, Harrison M, Goldstein RB. Characteristics of congenital cystic adenomatoid malformations associated with nonimmune hydrops and outcome. J Pediatr Surg. 2007 Aug;42(8):1351-6. Schumacher A, Sidor J, Bühling KJ. [Continuous glucose monitoring using the glucose sensor CGMS in metabolically normal pregnant women during betamethasone therapy for fetal respiratory distress syndrome]. Z Geburtshilfe Neonatol. 2006 Oct;210(5):184-90. German. Peltoniemi OM, Kari MA, Tammela O, Lehtonen L, Marttila R, Halmesmäki E, Jouppila P, Hallman M; Repeat Antenatal Betamethasone Study Group. Randomized trial of a single repeat dose of prenatal betamethasone treatment in imminent preterm birth. Pediatrics. 2007 Feb;119(2):290-8. Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004454. Review. Neilson JP. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Obstet Gynecol. 2007 Jan;109(1):189-90. Tsao K, Hawgood S, Vu L, Hirose S, Sydorak R, Albanese CT, Farmer DL, Harrison MR, Lee H. Resolution of hydrops fetalis in congenital cystic adenomatoid malformation after prenatal steroid therapy. J Pediatr Surg. 2003 Mar;38(3):508-10. Review. Arca MJ, Teich S. Current controversies in perinatal care: fetal versus neonatal surgery. Clin Perinatol. 2004 Sep;31(3):629-48. Review. Wilson RD, Baxter JK, Johnson MP, King M, Kasperski S, Crombleholme TM, Flake AW, Hedrick HL, Howell LJ, Adzick NS. Thoracoamniotic shunts: fetal treatment of pleural effusions and congenital cystic adenomatoid malformations. Fetal Diagn Ther. 2004 Sep-Oct;19(5):413-20. Knox EM, Kilby MD, Martin WL, Khan KS. In-utero pulmonary drainage in the management of primary hydrothorax and congenital cystic lung lesion: a systematic review. Ultrasound Obstet Gynecol. 2006 Oct;28(5):726-34. Review. Davenport M, Warne SA, Cacciaguerra S, Patel S, Greenough A, Nicolaides K. Current outcome of antenally diagnosed cystic lung disease. J Pediatr Surg. 2004 Apr;39(4):549-56. Review. Miller JA, Corteville JE, Langer JC. Congenital cystic adenomatoid malformation in the fetus: natural history and predictors of outcome. J Pediatr Surg. 1996 Jun;31(6):805-8.
Starting date: April 2008
Last updated: March 18, 2015
|