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...
Date First Received: April 30, 2008
Last Updated: June 9, 2008
Verified by: University of California, San Francisco, April 2008
Clinical Trial Phase: Phase 1/Phase 2 | Start Date: April 2008
Overall Status: Recruiting
Estimated Enrollment: 74
Brief Summary
Official Title: “Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs”
Condition Keyword(s):
Intervention(s):
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
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: April 2010
Intervention(s) in this Clinical Trial
- Drug: Betamethasone
- 12 mg intramuscularly x 2 doses 24 hours apart
- Drug: Placebo
- PLACEBO: IM x 2 doses 24 hours apart
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Active Study Group
- STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
- Placebo Comparator: Placebo Group
- PLACEBO: IM x 2 doses 24 hours apart
Outcome Measures for this Clinical Trial
Primary Measures
- Incidence of hydrops fetalis between study and control groups
- Time Frame: Delivery
Safety Issue?: No
- Time Frame: Delivery
Secondary Measures
- 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
Safety Issue?: No
- Time Frame: To delivery and 30 days post-delivery, respectively
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of California, San Francisco
Overall Clinical Trial Officials and Contacts
Timothy M Crombleholme, MD Principal Investigator Children's Hospital of Cincinnati
Overall Contact: Jody A Farrell, MSN, PNP 415-476-0445 fetus@surgery.ucsf.edu
Related Publications
References
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. No abstract available.
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.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00670956
Study ID Number: H11258-30459
ClinicalTrials.gov Identifier: NCT00670956
Health Authority: United States: Institutional Review Board
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
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