Diaphragmatic HerniaPhase 2NCT00373438
Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia
A Phase 2 study testing Fetoscopic tracheal balloon occlusion in people with Diaphragmatic Hernia, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Jul 2014
- Phase
- Phase 2
- 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 left diaphragmatic hernia.
- Normal karyotype, no further severe anomalies on prenatal ultrasound study.
- Fetal liver herniation into the chest; gestational age-related lung volume between 20-25% of normal as determined by magnetic resonance imaging between 30+0 - 34+0 weeks+days of gestation.
Who cannot join
- Any maternal disease or condition that would result in an increased risk to her health from the experimental procedure.
- Abnormal fetal karyotype, further severe fetal anomalies on prenatal ultrasound.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Center for Fetal Surgery & Minimally Invasive Therapy
Bonn, 53105
Thomas Kohl, MD, 0049-175-597-1213, thomas.kohl@ukb.uni-bonn.de
Thomas Schaible, MD, 0049-160-550-1023
About this study
Official title: Randomized Clinical Trial in Order to Assess the Effect of Fetoscopic Tracheal Balloon Occlusion on the Postnatal Disease Course in Neonates With Left Congenital Diaphragmatic Hernia - FDH-ECMO/BALLOON-TRIAL
Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants.
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 in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.
- Conditions
- Diaphragmatic Hernia
- Being tested
- Fetoscopic tracheal balloon occlusion
- Keywords
- Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy, ECMO
- 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
Maternal local anesthesia, percutaneous ultrasound-guided fetal analgo-sedation and relaxation, percutaneous ultrasound-guided access into amniotic cavity with trocar, fetoscopic tracheal ballon occlusion, removal of fetoscope and trocar, maternal abdominal closure, skin-to-skin time 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Not described Receives: Procedure: Fetoscopic tracheal balloon occlusion |
| B | Experimental | Fetoscopic tracheal occlusion Receives: Procedure: Fetoscopic tracheal balloon occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for postnatal ECMO therapy
Measured: First two days of life
Secondary outcomes (8)
Survival to discharge from hospital
Measured: Days to discharge
Maternal morbidity
Measured: Until maternal discharge
Fetal / Neonatal morbidity
Measured: Overall & at discharge from hospital
Premature preterm rupture of membranes
Measured: Following the interventions over the remainder of gestation
Unintended preterm delivery
Measured: Following the interventions before scheduled elective delivery
Days in intensive care
Measured: Number of day until discharge from ICU
Days in hospital
Measured: Number of days until discharge from hospital
Oxygen dependency on discharge
Measured: Days until 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 2009
- Primary completionJan 2014 (estimated)
- Study completionJul 2014 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- NCT00373438
- Sponsor's protocol ID
- FDH-ECMO/BALLOON-TRIAL-135/06
- Other IDs
- 135/06
- Status last verified
- Jan 2009
- First submitted
- 6 Sep 2006
- Last updated
- 6 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
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 6 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial in Order to Assess the Effect of Fetoscopic Tracheal Balloon Occlusion on the Postnatal Disease Course in Neonates With Left Congenital Diaphragmatic Hernia - FDH-ECMO/BALLOON-TRIAL
- ClinicalTrials.gov ID
- NCT00373438
- Acronym / sponsor ID
- FDH-ECMO/BALLOON-TRIAL-135/06
- Conditions
- Diaphragmatic Hernia
- Keywords
- Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy, ECMO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Universitätsmedizin Mannheim
- Study start
- Jan 2009
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- 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.
Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants.
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 in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | Procedure: Fetoscopic tracheal balloon occlusion |
| B | Experimental | Procedure: Fetoscopic tracheal balloon occlusionFetoscopic tracheal occlusion |
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 left diaphragmatic hernia.
- Normal karyotype, no further severe anomalies on prenatal ultrasound study.
- Fetal liver herniation into the chest; gestational age-related lung volume between 20-25% of normal as determined by magnetic resonance imaging between 30+0 - 34+0 weeks+days of gestation.
Key exclusion criteria (2 listed)
- Any maternal disease or condition that would result in an increased risk to her 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 occlusionMaternal local anesthesia, percutaneous ultrasound-guided fetal analgo-sedation and relaxation, percutaneous ultrasound-guided access into amniotic cavity with trocar, fetoscopic tracheal ballon occlusion, removal of fetoscope and trocar, maternal abdominal closure, skin-to-skin time 30 minutes | Procedure or surgery | A, B |
Primary outcome
Need for postnatal ECMO therapy
Time frame: First two days of life
8 secondary outcomes
Survival to discharge from hospital
Time frame: Days to discharge
Maternal morbidity
Time frame: Until maternal discharge
Fetal / Neonatal morbidity
Time frame: Overall & at discharge from hospital
Premature preterm rupture of membranes
Time frame: Following the interventions over the remainder of gestation
Unintended preterm delivery
Time frame: Following the interventions before scheduled elective delivery
Days in intensive care
Time frame: Number of day until discharge from ICU
Days in hospital
Time frame: Number of days until discharge from hospital
Oxygen dependency on discharge
Time frame: Days until discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2009.
- 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
Active, not recruiting
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
RecruitingPhase 4
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fetoscopic tracheal balloon occlusion in people with Diaphragmatic Hernia, run by University Hospital, Bonn 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 3 inclusion and 2 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 6 Jan 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Thomas Kohl, MD (-49-228-2871-5942, thomas.kohl@ukb.uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for postnatal ECMO therapy (time frame: First two days of life). 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 NCT00373438, 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 6 Jan 2009.