Fetal Tracheal Occlusion for Morgagni Hernias

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Morgagni Hernias+5 More
Fetal Tracheal Occlusion - Device
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial found that, for fetuses with congenital diaphragmatic hernia, tracheal occlusion increased the chance of being born alive and without major surgery.

Eligible Conditions
  • Morgagni Hernias
  • Hypertensive disease
  • Hypoplasia, Pulmonary

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 1 year

1 year
Change neonatal morbidity
Decreased neonatal morbidity
6 months
Change need for ECMO therapy
Change pulmonary hypertension
Change survival in the severe congenital diaphragmatic hernia subgroup
Decreased need for ECMO therapy
Decreased pulmonary hypertension
Improve survival in the severe congenital diaphragmatic hernia subgroup
Week 40
Change lung growth on prenatal imaging
Improved lung growth on prenatal imaging

Trial Safety

Trial Design

1 Treatment Group

Fetal Tracheal Occlusion
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Fetal Tracheal Occlusion · No Placebo Group · N/A

Fetal Tracheal Occlusion
Device
Experimental Group · 1 Intervention: Fetal Tracheal Occlusion · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
748 Previous Clinical Trials
5,418,383 Total Patients Enrolled
Kurt Schibler, MDStudy ChairCCHMC Oversight Data Safety Monitoring Committee
16 Previous Clinical Trials
15,657 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category.
Moderate pulmonary hypoplasia with ultrasound O/E LHR <30% and liver-up at the time of surgery.
You are gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category.
The fetal echocardiogram is normal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: November 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.