Severe Congenital Diaphragmatic HerniaLongTailFETONCT03431792
FETO With Long Tail Balloon for a Treatment of Severe CDH
A study testing Long Tail Balloon in people with Severe Congenital Diaphragmatic Hernia, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Severe Congenital Diaphragmatic Hernia
- What is being tested?
- Long Tail Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 30 Aug 2017to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- fetuses with other letal morphological abnormalities
- fetuses with chromosomal abnormalities
- severe maternal illneses
Trial locations and contacts
1 site in 1 country.
Michael Bergner, MD contact
Germany1 site, 1 recruiting
- Recruiting
Center of Fetal Surgery, Clinic of Obstetrics and Perinatal Medicine, Martin-Luther-University Halle-Wittenberg
Halle, 06120
Michael Tchirikov, MD, PhD, 0493455573250, geburtshilfe@uk-halle.de
Kathrin Reinsdorf, 0493455573245, reinsdorf@uk-halle.de
About this study
Official title: The Intrauterine Fetoscopic Tracheal Occlusion (FETO) With Long Tail Balloon for a Treatment of Severe Congenital Diaphragmatic Hernia (CDH)
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%).
Read more
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.
Read the 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.
- Conditions
- Severe Congenital Diaphragmatic Hernia
- Being tested
- Long Tail Balloon
- Keywords
- CDH, FETO, fetal surgery, long tail FETO
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long Tail BalloonDevice
- description of experimental Arm
| Study group | Role | What they receive |
|---|---|---|
| Long-Tail-FETO | Experimental | 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. Receives: Device: Long Tail Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal survival
survival rate
Measured: 1 year
Secondary outcomes (9)
pulmonary hypoplasia
clinical presence of pulmonary hypoplasia (yes - Grade /no)
Measured: 1 year
Diaphragmatic Hernia operation
Patch (yes/no)
Measured: 1 year
necrotizing enterocolitis
yes / no
Measured: 1 year
neurodevelopmental impairment
(yes, - Grade /no)
Measured: 1 year
APGAR
APGAR (1st/5th/10th min)
Measured: during the first 10 min after the delivery
umbilical artery pH
pH measument in the umbilical artery
Measured: during 10 min after the delivery
weight
weight in (g)
Measured: 24hour
length
neonatal length in cm
Measured: 24hour
Duration of O2-Ventilation (day)
Duration of O2-Ventilation (day)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start30 Aug 2017
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Tchirikov MD, PhD, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Michael Tchirikov, MD, PhD, Principal investigator, Germany, Center of Fetal Surgery, Martin-Luther University Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431792
- Sponsor's protocol ID
- 2017-104
- Acronym
- LongTailFETO
- Status last verified
- Feb 2018
- First submitted
- 24 Jan 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 19950374Tchirikov 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.
PubMed 19521091Jani 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.
PubMed 19658113
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intrauterine Fetoscopic Tracheal Occlusion (FETO) With Long Tail Balloon for a Treatment of Severe Congenital Diaphragmatic Hernia (CDH)
- ClinicalTrials.gov ID
- NCT03431792
- Acronym / sponsor ID
- LongTailFETO / 2017-104
- Conditions
- Severe Congenital Diaphragmatic Hernia
- Keywords
- CDH, FETO, fetal surgery, long tail FETO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Long-Tail-FETO | Experimental | Device: Long Tail BalloonFetus 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. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- fetuses with other letal morphological abnormalities
- fetuses with chromosomal abnormalities
- severe maternal illneses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long Tail Balloons. description of experimental Arm | Device | Long-Tail-FETO |
Primary outcome
neonatal survival
Time frame: 1 year
survival rate
9 secondary outcomes
pulmonary hypoplasia
Time frame: 1 year
Diaphragmatic Hernia operation
Time frame: 1 year
necrotizing enterocolitis
Time frame: 1 year
neurodevelopmental impairment
Time frame: 1 year
APGAR
Time frame: during the first 10 min after the delivery
umbilical artery pH
Time frame: during 10 min after the delivery
weight
Time frame: 24hour
length
Time frame: 24hour
Duration of O2-Ventilation (day)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Background: PubMed 19950374Tchirikov 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.
- Background: PubMed 19521091Tchirikov 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.
- Background: PubMed 19658113Jani 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bergner, MD contact
Michael Tchirikov, MD, PhD principal investigator
Germany, Center of Fetal Surgery, Martin-Luther University Halle-Wittenberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long Tail Balloon in people with Severe Congenital Diaphragmatic Hernia, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Tchirikov, MD, PhD (+49-345-557-3250, michael.tchirikov@uk-halle.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431792, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.