NCT03431792: LongTailFETO

FETO With Long Tail Balloon for a Treatment of Severe CDH

Status unknown NA Last updated 13 February 2018

What this trial tests

NA trial testing Long Tail Balloon in Severe Congenital Diaphragmatic Hernia in 20 participants. Status unknown.

Timeline

30 August 2017

Primary endpoint
30 August 2020

30 August 2021

Quick facts

Lead sponsor	Martin-Luther-Universität Halle-Wittenberg
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	30 August 2017
Primary completion	30 August 2020
Estimated completion	30 August 2021
Sites	1 location across Germany

Drugs / interventions tested

• Long Tail Balloon

Conditions studied

• Severe Congenital Diaphragmatic Hernia — all drugs for Severe Congenital Diaphragmatic Hernia →

Sponsor

Martin-Luther-Universität Halle-Wittenberg — full company profile →

Who can join

Adults 18 to 48, female only, with Severe Congenital Diaphragmatic Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns. The survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. In case of an observed / expected total fetal lung volume ratio (o/e TFLV) ratio of 25% or lower and herniation of the liver in thorax, the postnatal survival is estimated to be 10-25% or lower. The aim of fetoscopic tracheal balloon occlusion is to positively influence the lung growth in CDH fetuses avoiding the development of lung hypoplasia.

Some complications after sucsessfull FETO before delivery occur because of technical difficulties during the extraction of the balloon from the trachea, leading to asphyxia, worse outcome or neonatal demise. Jani et al. published 10 neonatal deaths from 210 FETO directly related to difficulties with the removal of the intratracheal balloon. The risk of emergent balloon removal was published to be very high (39%-56%).

Our new technique exploits the fetal ability to removal the intratracheal balloon which has been implanted for the treatment of severe CDH before the delivery, avoiding many risks associated with balloon extraction and a second fetoscopy.

The study will be performed on 20 fetuses with severe CDH. Before the FETO the total fetal lung volume ratio (o/e TFLV) will be measured by fetal MRI (magnetic . Only CDH fetuses with 24-32 weeks' gestation with o/e TFLV \< 25% or the fetuses with o/e TFLV \< 35% and liver herniation will be operated Second fetal MRI should be performed in one week after the FETO. The balloon will be extracted by the fetus itself before the delivery, after puncture with 22 gauge needle under ultrasound guiding, during second fetoscopy or using the EXIT (ex utero intrapartum Treatment). Neonatal follow up 12 months.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Long tail balloon as a new approach for fetoscopic tracheal occlusion for a treatment of severe congenital diaphragmatic hernia.
   Tchirikov M, Springer C, Seeger S, Behrmann C, et al · · 2019 · PMID 30656800 · DOI 10.1111/jog.13895