NCT00373438

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 6, 2009

Status Verified

January 1, 2009

Enrollment Period

5 years

First QC Date

September 6, 2006

Last Update Submit

January 5, 2009

Conditions

Diaphragmatic Hernia

Keywords

Congenital diaphragmatic herniatracheal occlusionfetusfetal surgeryfetoscopyECMO

Outcome Measures

Primary Outcomes (1)

  • Need for postnatal ECMO therapy

    First two days of life

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

A

NO INTERVENTION
Procedure: Fetoscopic tracheal balloon occlusion

B

EXPERIMENTAL

Fetoscopic tracheal occlusion

Procedure: Fetoscopic tracheal balloon occlusion

Interventions

Fetoscopic tracheal balloon occlusionPROCEDURE

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

AB

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Center for Fetal Surgery & Minimally Invasive Therapy

Bonn, 53105, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 16601345BACKGROUND

MeSH Terms

Conditions

Hernia, DiaphragmaticHernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Internal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Thomas Kohl, MD

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

    PRINCIPAL INVESTIGATOR

  • Thomas Schaible, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Kohl, MD

CONTACT

-49-228-2871-5942thomas.kohl@ukb.uni-bonn.de

Thomas Schaible, MD

CONTACT

-49-160-550-1023t.schaible@t-online.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

January 1, 2009

Primary Completion

January 1, 2014

Study Completion

July 1, 2014

Last Updated

January 6, 2009

Record last verified: 2009-01

Locations

DE(1)