Health TrialsbyHealthPanel

Fetoscopic Endoluminal Tracheal Occlusion

ConditionHernia, DIaphragmatic, Congenital
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChildren's Hospitals and Clinics of Minnesota

About this trial

This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A subject is defined as a female (18 years or older) who is pregnant.

The pregnancy must be a singleton pregnancy.

The CDH must be left-sided.

The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - < 25% from U/S measurements).

Disqualifiers

Twin or higher order gestation

Not able to consent

Right-sided or bilateral CDH

Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome

Trial design

Design model

Single group

Treatments tested in this trial

  • FETO therapy

    Device

    placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: FETO therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful placement of Balt Goldbal2 balloon

Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure.

Time frame
Prior to 29 weeks 6 days Gestational Age (GA)
2

Successful removal of Balt Goldbal2 balloon

Removal of the balloon

Time frame
Prior to 35 weeks 6 days GA

Secondary outcomes

1

Change in fetal lung growth

Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal.

Time frame
Immediately after intervention (device removal)
2

Gestational age at delivery

Gestational age at delivery will be recorded.

Time frame
Measured at time of delivery
3

Infant survival

Infant survival will be recorded from delivery to NICU discharge, and at 6, 12, and 24 months of age

Time frame
Birth - 24 months
4

Number of infants requiring extra corporeal membrane oxygenation (ECMO) support

Use of ECMO will be collected from medical chart review.

Time frame
Birth to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospitals and Clinics of Minnesota

Lead sponsor

Allina Health System

Collaborator

Source ClinicalTrials.gov
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