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Recruitment has been poor. Study drug is being offered as part of standard care of women carrying a pregnancy diagnosed with CCAM
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| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Children's Hospital of Philadelphia | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Study Group | Active Comparator | STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart |
|
| Placebo Group | Placebo Comparator | PLACEBO: IM x 2 doses 24 hours apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone | Drug | 12 mg intramuscularly x 2 doses 24 hours apart |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hydrops Fetalis | Delivery, up to approximately 20 weeks post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Status of neonate survival 30 days after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco Fetal Treatment Center | San Francisco | California | 94143 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17706495 | Background | 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. | |
| 17099841 | Background | 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. |
| Label | URL |
|---|---|
| Fetal Care Center of Cincinnati Children's Hospital | View source |
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Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Study Group | STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Study Group | STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Hydrops Fetalis | Only one participant was enrolled to the study before it was terminated; no participants were enrolled to the control arm | Posted | Number | participants | Delivery, up to approximately 20 weeks post-enrollment |
|
|
30 days post-delivery (up to approximately 24 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Study Group | STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart Betamethasone: 12 mg intramuscularly x 2 doses 24 hours apart |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hanmin Lee, MD | University of California San Francisco | 415-476-4086 | hanmin.lee@ucsf.edu |
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| ID | Term |
|---|---|
| D015615 | Cystic Adenomatoid Malformation of Lung, Congenital |
| D004487 | Edema |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015619 | Respiratory System Abnormalities |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo |
| Drug |
PLACEBO: IM x 2 doses 24 hours apart |
|
| 30 days after delivery (up to approximately 24 weeks post-enrollment) |
| Cincinnati Children's Hospital |
| Cincinnati |
| Ohio |
| 45229-3039 |
| United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| 17272618 | Background | 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. |
| 16856047 | Background | 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. |
| 17233108 | Background | 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. |
| 12632377 | Background | 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. |
| 15325542 | Background | 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. |
| 15305098 | Background | 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. |
| 17001747 | Background | 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. |
| 15065026 | Background | 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. |
| 8783108 | Background | 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. |
| Fetal Treatment Center at the University of California, San Francisco | View source |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo) | Study was terminated without enrollment to control arm; therefore, no comparison was made | Posted | Baseline, Delivery (up to approximately 20 weeks post-enrollment) |
|
|
| Secondary | Survival at One-month Between Study and Control Groups. | Status of neonate survival 30 days after delivery | Posted | Number | participants | 30 days after delivery (up to approximately 24 weeks post-enrollment) |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |