Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

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.

Study Overview

• Status: Unknown
• Conditions: Diaphragmatic Hernia
• Intervention / Treatment: Procedure: Fetoscopic tracheal balloon occlusion

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Thomas Kohl, MD; Phone Number: -49-228-2871-5942; Email: thomas.kohl@ukb.uni-bonn.de
• Study Contact Backup: Name: Thomas Schaible, MD; Phone Number: -49-160-550-1023; Email: t.schaible@t-online.de

Study Locations

• Germany
  • Bonn, Germany, 53105
    • Recruiting
    • German Center for Fetal Surgery & Minimally Invasive Therapy
    • Contact: Thomas Kohl, MD; Phone Number: 0049-175-597-1213; Email: thomas.kohl@ukb.uni-bonn.de
    • Contact: Thomas Schaible, MD; Phone Number: 0049-160-550-1023
    • Principal Investigator: Thomas Kohl, MD
    • Principal Investigator: Thomas Schaible, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: A	Procedure: Fetoscopic tracheal balloon occlusion; 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
EXPERIMENTAL: B; Fetoscopic tracheal occlusion	Procedure: Fetoscopic tracheal balloon occlusion; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Need for postnatal ECMO therapy	First two days of life

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival to discharge from hospital	Days to discharge
Maternal morbidity	Until maternal discharge
Fetal / Neonatal morbidity	Overall & at discharge from hospital
Premature preterm rupture of membranes	Following the interventions over the remainder of gestation
Unintended preterm delivery	Following the interventions before scheduled elective delivery
Days in intensive care	Number of day until discharge from ICU
Days in hospital	Number of days until discharge from hospital
Oxygen dependency on discharge	Days until discharge

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Collaborators: Universitätsmedizin Mannheim

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ANTICIPATED): January 1, 2014
• Study Completion (ANTICIPATED): July 1, 2014

Study Registration Dates

• First Submitted: September 6, 2006
• First Submitted That Met QC Criteria: September 6, 2006
• First Posted (ESTIMATE): September 8, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): January 6, 2009
• Last Update Submitted That Met QC Criteria: January 5, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Keywords: ECMO; Congenital diaphragmatic hernia; fetoscopy; fetal surgery; tracheal occlusion; fetus
• Additional Relevant MeSH Terms: Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Hernia; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: FDH-ECMO/BALLOON-TRIAL-135/06; 135/06