NCT00373763

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Trial Relationships

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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
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Last Updated

August 25, 2008

Status Verified

August 1, 2008

Enrollment Period

1 year

First QC Date

September 6, 2006

Last Update Submit

August 22, 2008

Conditions

Diaphragmatic Hernia

Keywords

Congenital diaphragmatic herniatracheal occlusionfetusfetal surgeryfetoscopy

Outcome Measures

Primary Outcomes (1)

  • Survival to discharge from hospital

Secondary Outcomes (9)

  • Maternal morbidity

  • Fetal morbidity

  • Premature preterm rupture of membranes

  • Unintended preterm delivery

  • Conventional ventilation strategies possible

  • +4 more secondary outcomes

Interventions

Fetoscopic tracheal balloon occlusionPROCEDURE

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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Bonn, 53105, Germany

Location

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

Mannheim, 68167, Germany

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Last Updated

August 25, 2008

Record last verified: 2008-08

Locations

DE(2)