๐ฌIn plain words
What the trial is, and whether it could suit you
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Pregnant women age 18 years and older, who are able to consent
* Singleton pregnancy
Fetal
* Normal Karyotype
* Fetal Diagnosis of Isolated Left CDH with liver up
* Gestation at enrollment prior to 29 wks plus 6 days
* SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25%
Exclusion Criteria:
* Pregnant women \<18 years of age.
* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
* Technical limitations precluding fetoscopic surgery
* Rubber latex allergy
* Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
* Psychosocial ineligibility, precluding consent
* Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR โฅ 25%
* Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care
๐
What it tests
- Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Connecticut Children's Medical Center
Hartford, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.