Diaphragmatic HerniaNCT00373763
Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
A study testing Fetoscopic tracheal balloon occlusion in people with Diaphragmatic Hernia, run by University Hospital, Bonn at 2 sites in Germany.
Trial summary
Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diaphragmatic Hernia
- What is being tested?
- Fetoscopic tracheal balloon occlusion
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2007to Jan 2008
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women from European countries carrying fetuses with congenital right or left diaphragmatic hernias
- Normal karyotype, no further severe anomalies on prenatal ultrasound study
- Fetal liver herniation into the chest, Lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation
Who cannot join
- Any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure
- Abnormal fetal karyotype
- Further severe fetal anomalies on prenatal ultrasound
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn
Bonn, 53105
Neonatal Intensive Care Unit (ECMO center), University of Mannheim
Mannheim, 68167
About this study
Official title: Randomized Clinical Trial for the Assessment of the Life-Saving Potential of Fetoscopic Tracheal Balloon Occlusion in Fetuses With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.
- Conditions
- Diaphragmatic Hernia
- Being tested
- Fetoscopic tracheal balloon occlusion
- Keywords
- Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy
- Medical subject headings
- Hernia, Diaphragmatic, Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscopic tracheal balloon occlusionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to discharge from hospital
Secondary outcomes (9)
Maternal morbidity
Fetal morbidity
Premature preterm rupture of membranes
Unintended preterm delivery
Conventional ventilation strategies possible
ECMO required
Days in intensive care
Days in hospital
Oxygen dependency on discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startJan 2007
- Primary completionJan 2008
Why it stopped: No patients could be recruited and randomized due to other center offering backdoor for treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsmedizin Mannheim
- Investigators
- Thomas Kohl, MD, Principal investigator, German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, GermanyThomas Schaible, MD, Principal investigator, Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373763
- Sponsor's protocol ID
- DH-EUROTRIAL I - 093/06
- Other IDs
- 093/06
- Status last verified
- Aug 2008
- First submitted
- 6 Sep 2006
- Last updated
- 25 Aug 2008
- Results posted
- No
Publications
Kohl T, Gembruch U, Filsinger B, Hering R, Bruhn J, Tchatcheva K, Aryee S, Franz A, Heep A, Muller A, Bartmann P, Loff S, Hosie S, Neff W, Schaible T; German Center for Fetal Surgery Diaphragmatic Hernia Task Group. Encouraging early clinical experience with deliberately delayed temporary fetoscopic tracheal occlusion for the prenatal treatment of life-threatening right and left congenital diaphragmatic hernias. Fetal Diagn Ther. 2006;21(3):314-8. doi: 10.1159/000091363.
PubMed 16601345
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for the Assessment of the Life-Saving Potential of Fetoscopic Tracheal Balloon Occlusion in Fetuses With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I
- ClinicalTrials.gov ID
- NCT00373763
- Acronym / sponsor ID
- DH-EUROTRIAL I - 093/06
- Conditions
- Diaphragmatic Hernia
- Keywords
- Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients could be recruited and randomized due to other center offering backdoor for treatment.
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Universitätsmedizin Mannheim
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- First posted
- 8 Sep 2006 (estimated)
- 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.
Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women from European countries carrying fetuses with congenital right or left diaphragmatic hernias
- Normal karyotype, no further severe anomalies on prenatal ultrasound study
- Fetal liver herniation into the chest, Lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation
Key exclusion criteria (3 listed)
- Any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure
- Abnormal fetal karyotype
- Further severe fetal anomalies on prenatal ultrasound
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 |
|---|---|---|
| Fetoscopic tracheal balloon occlusion | Procedure or surgery | – |
Primary outcome
Survival to discharge from hospital
9 secondary outcomes
Maternal morbidity
Fetal morbidity
Premature preterm rupture of membranes
Unintended preterm delivery
Conventional ventilation strategies possible
ECMO required
Days in intensive care
Days in hospital
Oxygen dependency on discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
- Background: PubMed 16601345Kohl T, Gembruch U, Filsinger B, Hering R, Bruhn J, Tchatcheva K, Aryee S, Franz A, Heep A, Muller A, Bartmann P, Loff S, Hosie S, Neff W, Schaible T; German Center for Fetal Surgery Diaphragmatic Hernia Task Group. Encouraging early clinical experience with deliberately delayed temporary fetoscopic tracheal occlusion for the prenatal treatment of life-threatening right and left congenital diaphragmatic hernias. Fetal Diagn Ther. 2006;21(3):314-8. doi: 10.1159/000091363.
Related trials for Diaphragmatic Hernia
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
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Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
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De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
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.
Thomas Kohl, MD principal investigator
German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany
Thomas Schaible, MD principal investigator
Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopic tracheal balloon occlusion in people with Diaphragmatic Hernia, run by University Hospital, Bonn at 2 sites 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 3 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: withdrawn, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to discharge from hospital. 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 NCT00373763, which also lists 1 linked publication.
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 25 Aug 2008.