Fetal Tracheal Balloon Study in Diaphragmatic Hernia

Stopped early · Phase 2

Conditions studied: Diaphragmatic Hernia, Lung Disease

In brief

The purpose of this phase 2 limited study is to examine whether prenatal intervention correct the lung underdevelopment associated with severe diaphragmatic hernia.

Key facts

Study ID

NCT00966823

Run by

Rhode Island Hospital

People needed

3

Starts

2008-09-01

Expected to finish

2015-01-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Preterm labor, premature rupture of membranes or amniotic leak
• Significant maternal morbidity
• Minor (<18 years)

Where it is running

• Rhode Island Hospital/Women & Infants' Hospital of Rhode Island — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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