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FETO With Long Tail Balloon for a Treatment of Severe CDH (LongTailFETO)

Primary Purpose

Severe Congenital Diaphragmatic Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Long Tail Balloon
Sponsored by
Martin-Luther-Universität Halle-Wittenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Congenital Diaphragmatic Hernia focused on measuring CDH, FETO, fetal surgery, long tail FETO

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • maternal age of 18-48 years
  • severe CDH with MRI measured observed/expected total fetal lung volume (o/e TFLV) < 25% or < 35% in combination with a liver herniation into the thorax.

Exclusion Criteria:

  • fetuses with other letal morphological abnormalities
  • fetuses with chromosomal abnormalities
  • severe maternal illneses

Sites / Locations

  • Center of Fetal Surgery, Clinic of Obstetrics and Perinatal Medicine, Martin-Luther-University Halle-WittenbergRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Long-Tail-FETO

Arm Description

Fetus with severe CDH and o/e TFLV Ratio of < 25% or < 35% with liver herniation. The Long tail FETO will performed between 26 and 30 weeks of gestation. The MRI control will be perfirmed ar 32-34 weeks of gestation. Long Tail FETO: fetal i.m. application of 0.1 mg/kg Pancuronium, 1 µg/kg Fentanyl® and 0.01 mg/kg atropine. ("Long-Tail" Goldbal 5, 2,5 ml, BALT Extrusion, Montmorency, France). The fetoscope (Karl Storz, Tuttlingen, Germany) with a diameter of 1.3 mm, will be percutaneously inserted through a sheath into the uterus and then into the fetal trachea. The fetoscope will be removed and the balloon will be inserted under 4-D ultrasound guidance into the fetal trachea. The position of the balloon and suture will be visualized using the fetoscopy. The Long tail ballon will be removed by a second FETO after 34 weeks' gestation or bei the fetus itself with or without of the long tail balloon puncture with 22 gauge needle. The EXIT procedure is also possible.

Outcomes

Primary Outcome Measures

neonatal survival
survival rate

Secondary Outcome Measures

pulmonary hypoplasia
clinical presence of pulmonary hypoplasia (yes - Grade /no)
Diaphragmatic Hernia operation
Patch (yes/no)
necrotizing enterocolitis
yes / no
neurodevelopmental impairment
(yes, - Grade /no)
APGAR
APGAR (1st/5th/10th min)
umbilical artery pH
pH measument in the umbilical artery
weight
weight in (g)
length
neonatal length in cm
Duration of O2-Ventilation (day)
Duration of O2-Ventilation (day)

Full Information

First Posted
January 24, 2018
Last Updated
February 12, 2018
Sponsor
Martin-Luther-Universität Halle-Wittenberg
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1. Study Identification

Unique Protocol Identification Number
NCT03431792
Brief Title
FETO With Long Tail Balloon for a Treatment of Severe CDH
Acronym
LongTailFETO
Official Title
The Intrauterine Fetoscopic Tracheal Occlusion (FETO) With Long Tail Balloon for a Treatment of Severe Congenital Diaphragmatic Hernia (CDH)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns, depending on whether stillbirths are included or not. 40 % of all CDH cases show associated malformations and chromosomal abnormalities and/or syndromes take place in 10-20%. The survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. Liver herniation into the thorax, is also a negative predictor of fetal survival. 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. A common complication of fetal surgery is the preterm premature rupture of membranes (PPROM) leading to preterm delivery. The next problem occurs 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 long tail balloon 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 with total fetal lung volume ratio (o/e TFLV) < 25% or with o/e TFLV < 35% combined with liver herniation into the thorax. The lung volume will be estimated by fetal MRI. The selected fetuses with severe CDH at 24-32 weeks' gestation will be operated. Before the Long tail FETO the 0.1 mg/kg Pancuronium, 1 µg/kg Fentanyl® and 0.01 mg/kg atropine will be applicated i.m. to the CDH fetus using 22 gauge needle under ultrasound control. The monofilament 5-0 polypropylene suture of 7 cm will be fixed to the balloon (Goldbal 5, 2,5 ml, BALT Extrusion, Montmorency, France) and the FETO will be performed. The fetoscope (Karl Storz, Tuttlingen, Germany) with a diameter of 1.3 mm will be percutaneously inserted through a sheath into the uterus and then into the fetal trachea. The fetoscope will be removed and the long tail balloon will be inserted under 4-D ultrasound guidance.The position of the balloon and suture will be controlled by fetoscopy and sonography. Second fetal MRI should be performed in one week after the FETO. The balloon must be extracted before the delivery. Possibilities of the Long tail extraction: The fetus is able to extract the balloon from the trachea after FETO, by pulling the balloons' long tail, at the end of pregnancy; by fetus itself after balloon puncture with 22 gauge needle under ultrasound guiding; during second fetoscopy; or using the EXIT procedure. The CDH will be closed with / or without a patch. The follow up examinations will be performed at 6 and 12 months of age the baby.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Congenital Diaphragmatic Hernia
Keywords
CDH, FETO, fetal surgery, long tail FETO

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Treatment of fetuses with severe CDH with an observed / expected total fetal lung volume ratio (o/e TFLV) ratio < 25% or with o/e TFLV ratio < 35% combined with herniation of the liver in thorax using the intrauterine fetoscopic tracheal occlusion (FETO) with the long tail latex balloon of 2.5 ml.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long-Tail-FETO
Arm Type
Experimental
Arm Description
Fetus with severe CDH and o/e TFLV Ratio of < 25% or < 35% with liver herniation. The Long tail FETO will performed between 26 and 30 weeks of gestation. The MRI control will be perfirmed ar 32-34 weeks of gestation. Long Tail FETO: fetal i.m. application of 0.1 mg/kg Pancuronium, 1 µg/kg Fentanyl® and 0.01 mg/kg atropine. ("Long-Tail" Goldbal 5, 2,5 ml, BALT Extrusion, Montmorency, France). The fetoscope (Karl Storz, Tuttlingen, Germany) with a diameter of 1.3 mm, will be percutaneously inserted through a sheath into the uterus and then into the fetal trachea. The fetoscope will be removed and the balloon will be inserted under 4-D ultrasound guidance into the fetal trachea. The position of the balloon and suture will be visualized using the fetoscopy. The Long tail ballon will be removed by a second FETO after 34 weeks' gestation or bei the fetus itself with or without of the long tail balloon puncture with 22 gauge needle. The EXIT procedure is also possible.
Intervention Type
Device
Intervention Name(s)
Long Tail Balloon
Intervention Description
s. description of experimental Arm
Primary Outcome Measure Information:
Title
neonatal survival
Description
survival rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
pulmonary hypoplasia
Description
clinical presence of pulmonary hypoplasia (yes - Grade /no)
Time Frame
1 year
Title
Diaphragmatic Hernia operation
Description
Patch (yes/no)
Time Frame
1 year
Title
necrotizing enterocolitis
Description
yes / no
Time Frame
1 year
Title
neurodevelopmental impairment
Description
(yes, - Grade /no)
Time Frame
1 year
Title
APGAR
Description
APGAR (1st/5th/10th min)
Time Frame
during the first 10 min after the delivery
Title
umbilical artery pH
Description
pH measument in the umbilical artery
Time Frame
during 10 min after the delivery
Title
weight
Description
weight in (g)
Time Frame
24hour
Title
length
Description
neonatal length in cm
Time Frame
24hour
Title
Duration of O2-Ventilation (day)
Description
Duration of O2-Ventilation (day)
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: maternal age of 18-48 years severe CDH with MRI measured observed/expected total fetal lung volume (o/e TFLV) < 25% or < 35% in combination with a liver herniation into the thorax. Exclusion Criteria: fetuses with other letal morphological abnormalities fetuses with chromosomal abnormalities severe maternal illneses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Tchirikov, MD, PhD
Phone
+49-345-557-3250
Email
michael.tchirikov@uk-halle.de
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Bergner, MD
Email
michael.bergner@uk-halle.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Tchirikov, MD, PhD
Organizational Affiliation
Germany, Center of Fetal Surgery, Martin-Luther University Halle-Wittenberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Fetal Surgery, Clinic of Obstetrics and Perinatal Medicine, Martin-Luther-University Halle-Wittenberg
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Tchirikov, MD, PhD
Phone
0493455573250
Email
geburtshilfe@uk-halle.de
First Name & Middle Initial & Last Name & Degree
Kathrin Reinsdorf
Phone
0493455573245
Email
reinsdorf@uk-halle.de

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All patients: only the Nr. of the patient will be available, diagnosis, diaphragmatic hernia left or right, liver herniation, o/e total volume lung ration (%), gestational age at the Operation (long tail FETO), gestational age of the delivery, PPROM (yes/no), APGAR, art. pH, weight.
IPD Sharing Time Frame
when summary data are published
IPD Sharing URL
https://web.uk-halle.de/index.php?id=7769
Citations:
PubMed Identifier
19950374
Citation
Tchirikov M, Gatopoulos G, Strohner M, Puhl A, Steetskamp J. Two new approaches in intrauterine tracheal occlusion using an ultrathin fetoscope. Laryngoscope. 2010 Feb;120(2):394-8. doi: 10.1002/lary.20687.
Results Reference
background
PubMed Identifier
19521091
Citation
Tchirikov M. Successful tracheal occlusion using ultrathin fetoscopic equipment combined with real-time three-dimensional ultrasound. Eur Surg Res. 2009;43(2):204-7. doi: 10.1159/000224146. Epub 2009 Jun 10.
Results Reference
background
PubMed Identifier
19658113
Citation
Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.
Results Reference
background

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FETO With Long Tail Balloon for a Treatment of Severe CDH

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