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

Phase 1

Terminated

• Conditions: Congenital Cystic Adenomatoid Malformation
• Interventions: Drug: Placebo; Drug: Betamethasone

• Registration Number: NCT00670956
• Lead Sponsor: University of California, San Francisco

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-30
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-03
• Results First Submitted: 2015-03-18
• Results First Submitted QC: 2015-03-18
• Last Update Submitted: 2015-03-18
• Results First Posted: 2015-03-30
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	PLACEBO: IM x 2 doses 24 hours apart
Active Study Group	Betamethasone	STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart

Primary Outcome Measures

Name	Time	Method
Incidence of Hydrops Fetalis	Delivery, up to approximately 20 weeks post-enrollment

Secondary Outcome Measures

Name	Time	Method
Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)	Baseline, Delivery (up to approximately 20 weeks post-enrollment)
Survival at One-month Between Study and Control Groups.	30 days after delivery (up to approximately 24 weeks post-enrollment)	Status of neonate survival 30 days after delivery

Trial Locations

Locations (3)

University of California, San Francisco Fetal Treatment Center; 🇺🇸 San Francisco, California, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States