Status:
TERMINATED
Fetal Tracheal Balloon Study in Diaphragmatic Hernia
Lead Sponsor:
Rhode Island Hospital
Conditions:
Diaphragmatic Hernia
Lung Disease
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this phase 2 limited study is to examine whether prenatal intervention correct the lung underdevelopment associated with severe diaphragmatic hernia.
Detailed Description
Congenital diaphragmatic hernia (CDH) has traditionally been associated with very high mortality rates. Most infants died of pulmonary hypoplasia and severe pulmonary hypertension. This led to correct...
Eligibility Criteria
Inclusion
- Singleton pregnancies
- Isolated congenital diaphragmatic hernia
- Normal karyotype (amniocentesis)
- Initial diagnosis before 26 weeks gestation
- Competent cervix
- Severity of CDH: lung-to-head ratio (LHR) ≤0.8 at 22-26 weeks gestation
- Liver herniation in the chest
- Informed consent
Exclusion
- Preterm labor, premature rupture of membranes or amniotic leak
- Significant maternal morbidity
- Minor (\<18 years)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00966823
Start Date
September 1 2008
End Date
January 1 2015
Last Update
May 30 2017
Active Locations (1)
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1
Rhode Island Hospital/Women & Infants' Hospital of Rhode Island
Providence, Rhode Island, United States, 02903