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Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

Primary Purpose

Diaphragmatic Hernia

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Fetoscopic tracheal balloon occlusion

About this trial

This is an interventional treatment trial for Diaphragmatic Hernia focused on measuring Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy, ECMO

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

German Center for Fetal Surgery & Minimally Invasive TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

Fetoscopic tracheal occlusion

Outcomes

Primary Outcome Measures

Need for postnatal ECMO therapy

Secondary Outcome Measures

Survival to discharge from hospital

Maternal morbidity

Fetal / Neonatal morbidity

Premature preterm rupture of membranes

Unintended preterm delivery

Days in intensive care

Days in hospital

Oxygen dependency on discharge

Full Information

NCT ID

NCT00373438

First Posted

September 6, 2006

Last Updated

January 5, 2009

Sponsor

University Hospital, Bonn

Collaborators

Universitätsmedizin Mannheim

1. Study Identification

Unique Protocol Identification Number

NCT00373438

Brief Title

Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Bonn

Collaborators

Universitätsmedizin Mannheim

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diaphragmatic Hernia

Keywords

Congenital diaphragmatic hernia, tracheal occlusion, fetus, fetal surgery, fetoscopy, ECMO

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Title

Arm Type

Experimental

Arm Description

Fetoscopic tracheal occlusion

Intervention Type

Procedure

Intervention Name(s)

Fetoscopic tracheal balloon occlusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Need for postnatal ECMO therapy

Time Frame

First two days of life

Secondary Outcome Measure Information:

Title

Survival to discharge from hospital

Time Frame

Days to discharge

Title

Maternal morbidity

Time Frame

Until maternal discharge

Title

Fetal / Neonatal morbidity

Time Frame

Overall & at discharge from hospital

Title

Premature preterm rupture of membranes

Time Frame

Following the interventions over the remainder of gestation

Title

Unintended preterm delivery

Time Frame

Following the interventions before scheduled elective delivery

Title

Days in intensive care

Time Frame

Number of day until discharge from ICU

Title

Days in hospital

Time Frame

Number of days until discharge from hospital

Title

Oxygen dependency on discharge

Time Frame

Days until discharge

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Kohl, MD

Phone

-49-228-2871-5942

thomas.kohl@ukb.uni-bonn.de

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Schaible, MD

Phone

-49-160-550-1023

t.schaible@t-online.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Kohl, MD

Organizational Affiliation

German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thomas Schaible, MD

Organizational Affiliation

Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

German Center for Fetal Surgery & Minimally Invasive Therapy

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Kohl, MD

Phone

0049-175-597-1213

thomas.kohl@ukb.uni-bonn.de

First Name & Middle Initial & Last Name & Degree

Thomas Schaible, MD

Phone

0049-160-550-1023

First Name & Middle Initial & Last Name & Degree

Thomas Kohl, MD

First Name & Middle Initial & Last Name & Degree

Thomas Schaible, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

16601345

Citation

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.

Results Reference

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Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

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