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

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ClinicalTrials.gov Identifier: NCT00670956

Recruitment Status : Terminated (Recruitment has been poor. Study drug is being offered as part of standard care of women carrying a pregnancy diagnosed with CCAM)

First Posted : May 2, 2008

Results First Posted : March 30, 2015

Last Update Posted : March 30, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Children's Hospital Medical Center, Cincinnati

Children's Hospital of Philadelphia

Information provided by (Responsible Party):

University of California, San Francisco

Study Description

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

Condition or disease	Intervention/treatment	Phase
Congenital Cystic Adenomatoid Malformation	Drug: Betamethasone Drug: Placebo	Phase 1 Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs
Study Start Date :	April 2008
Actual Primary Completion Date :	September 2011
Actual Study Completion Date :	September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Betamethasone

Genetic and Rare Diseases Information Center resources: Cystic Adenomatoid Malformation of Lung

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Active Study Group STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart	Drug: Betamethasone 12 mg intramuscularly x 2 doses 24 hours apart
Placebo Comparator: Placebo Group PLACEBO: IM x 2 doses 24 hours apart	Drug: Placebo PLACEBO: IM x 2 doses 24 hours apart

Outcome Measures

Primary Outcome Measures :

Incidence of Hydrops Fetalis [ Time Frame: Delivery, up to approximately 20 weeks post-enrollment ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670956

Locations

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United States, California
University of California, San Francisco Fetal Treatment Center
San Francisco, California, United States, 94143
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of California, San Francisco

Children's Hospital Medical Center, Cincinnati

Children's Hospital of Philadelphia

Investigators

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Principal Investigator:	Timothy M Crombleholme, MD	Children's Hospital of Cincinnati
Principal Investigator:	Douglas Wilson, MD	Children's Hospital of Philadelphia
Principal Investigator:	Hanmin Lee, MD	University of California, San Francisco

More Information

Additional Information:

Fetal Care Center of Cincinnati Children's Hospital This link exits the ClinicalTrials.gov site

Fetal Treatment Center at the University of California, San Francisco This link exits the ClinicalTrials.gov site

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. doi: 10.1016/j.jpedsurg.2007.03.039.

Schumacher A, Sidor J, Buhling 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. doi: 10.1055/s-2006-951743. German.

Peltoniemi OM, Kari MA, Tammela O, Lehtonen L, Marttila R, Halmesmaki 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. doi: 10.1542/peds.2006-1549.

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. doi: 10.1002/14651858.CD004454.pub2.

Neilson JP. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Obstet Gynecol. 2007 Jan;109(1):189-90. doi: 10.1097/01.aog.0000251610.51286.b1. 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. doi: 10.1053/jpsu.2003.50089.

Arca MJ, Teich S. Current controversies in perinatal care: fetal versus neonatal surgery. Clin Perinatol. 2004 Sep;31(3):629-48. doi: 10.1016/j.clp.2004.03.016.

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. doi: 10.1159/000078994.

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. doi: 10.1002/uog.3812.

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. doi: 10.1016/j.jpedsurg.2003.12.021.

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. doi: 10.1016/s0022-3468(96)90138-4.

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Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00670956
Other Study ID Numbers:	10-03705
First Posted:	May 2, 2008 Key Record Dates
Results First Posted:	March 30, 2015
Last Update Posted:	March 30, 2015
Last Verified:	March 2015

Keywords provided by University of California, San Francisco:


prenatal steroids hydrops congenital cystic adenomatoid malformation of the lung	prenatal intervention betamethasone prenatal diagnosis

Additional relevant MeSH terms:

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Cystic Adenomatoid Malformation of Lung, Congenital Congenital Abnormalities Lung Diseases Respiratory Tract Diseases Respiratory System Abnormalities Betamethasone Anti-Inflammatory Agents	Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents

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