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

This study has been withdrawn prior to enrollment.
(Recruitment has been poor. Study drug is being offered as part of standard care of women carrying a pregnancy diagnosed with CCAM)
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00670956
First received: April 30, 2008
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Congenital Cystic Adenomatoid Malformation
Drug: Betamethasone
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Incidence of hydrops fetalis between study and control groups [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: April 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670956

Locations
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
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:
Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00670956     History of Changes
Other Study ID Numbers: 10-03705
Study First Received: April 30, 2008
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board

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:
Congenital Abnormalities
Cystic Adenomatoid Malformation of Lung, Congenital
Lung Diseases
Respiratory System Abnormalities
Respiratory Tract Diseases
Betamethasone
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone-17,21-dipropionate
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014