Fetal tracheal occlusion for severe congenital diaphragmatic hernia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility and efficacy of fetal tracheal occlusion (FETO) in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH) characterized by liver-up and significant pulmonary hypoplasia. Eligible participants include singleton pregnancies with specific ultrasound findings and gestational age criteria. The intervention aims to improve lung development and overall outcomes for affected fetuses. The study is conducted at Cincinnati Children's Hospital Medical Center, focusing on a targeted patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Isolated CDH with liver up
* Severe pulmonary hypoplasia with ultrasound O/E LHR \<25% at the time of surgery
* Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
* Moderate pulmonary hypoplasia with ultrasound O/E LHR \<30% and liver-up at the time of surgery
* Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
* Maternal age greater than or equal to 18 years
* Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
* Normal karyotype or FISH
* Normal fetal echocardiogram
* Singleton pregnancy
* Willing to remain in the greater Cincinnati area for remainder of pregnancy
* Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
* Family meets psychosocial criteria

Exclusion Criteria:

* Patient \< 18 years old
* Multi-fetal pregnancy
* Rubber latex allergy
* Preterm labor, cervix shortened (\<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
* Bilateral CDH, isolated left sided CDH with an O/E \> 30%
* Additional fetal anomaly by ultrasound, MRI, or echocardiogram
* Chromosomal abnormalities
* Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
* Incompetent cervix with or without a cerclage
* Placental abnormalities known at time of enrollment
* Maternal HIV, Hepatits B, Hepatitis C
* Maternal uterine anomaly
* No safe or technically feasible fetoscopic approach to balloon placement
* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Where it's running

• Cincinnati Children's Hospital Medical Center (CCHMC)
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Foong-Yen Lim, MD
• Email: Foong-Yen.Lim@cchmc.org
• Phone: (513) 636-6259

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fetal tracheal occlusion (FETO) for severe congenital diaphragmatic hernia

  This trial will test whether fetal endoluminal tracheal occlusion (FETO) helps fetuses with severe congenital diaphragmatic hernia and intrathoracic liver herniation survive to hospital discharge.

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• Fetal treatment for congenital diaphragmatic hernia

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• Fetoscopic tracheal balloon occlusion for severe left congenital diaphragmatic hernia

  This research will try placing a temporary balloon in the fetal windpipe to help lungs grow in pregnancies where the baby has a severe left congenital diaphragmatic hernia.

  Recruiting University of Miami · Miami, Florida and 1 other locations · NCT03138863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.