Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is higher than 90% due to severe pulmonary hypoplasia. Many studies have suggested that fetal tracheal occlusion may increase lung volumes and therefore reducing the risk for severe pulmonary hypoplasia and by consequence the risk for neonatal death.

The main objective of the present study is to evaluate if fetal tracheal occlusion improves survival rate in those cases that are followed in our hospital, by conducing a randomized trial.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fetal Surgery for Moderate Left Sided Congenital Diaphragmatic Hernia.

NCT00763737

Congenital Diaphragmatic Hernia Fetal Surgery Pulmonary Hypoplasia

COMPLETED NA

Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia

NCT01240057

Congenital Diseases Diaphragmatic Hernia Pulmonary Hypoplasia

COMPLETED PHASE2/PHASE3

Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

NCT00373763

Diaphragmatic Hernia

WITHDRAWN NA

Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

NCT00373438

Diaphragmatic Hernia

UNKNOWN PHASE2

Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

NCT02986087

Congenital Diaphragmatic Hernia Pulmonary Hypoplasia Pulmonary; Hypertension

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Fetuses will be randomly allocated in two groups: 1. for fetal tracheal occlusion at 26-28 weeks (FETO group) or 2. Postnatal therapy only (Control)

Main outcome: Survival rate in both groups Second outcomes: Postnatal diagnosis of severe pulmonary arterial hypertension, percentage of newborns in each group that will have clinical conditions for neonatal surgical repair of the diaphragmatic defect, fetal lung responses (increase of fetal lung size), maternal and obstetrical complications (prematurity, preterm rupture of the membranes, maternal hemorrhage and infection).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Diaphragmatic Hernia Congenital Abnormality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fetal intervention

Composed of fetuses that undergo to fetal tracheal occlusion at 26-28 weeks.

Group Type EXPERIMENTAL

Fetal tracheal occlusion

Intervention Type PROCEDURE

Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy

Control

Composed of fetuses that do not undergo fetal intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fetal tracheal occlusion

Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FETO, TO

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ultrasound diagnosis of congenital diaphragmatic hernia
* fetuses at gestational age between 24 and 28 weeks
* absence of chromosomal and/or other structural anomalies (isolated congenital diaphragmatic hernia)
* severe congenital diaphragmatic hernia defined by lung-head ratio \< 1.0 and more than 1/3 of liver herniated into fetal thorax and observed/expected fetal total lung volume \< 0.35
* patient's consent to participate in the present study

Exclusion Criteria

* Patient's refusal to participate in the study after allocation
* Preterm labor diagnosed before the procedure
* Preterm rupture of membranes before fetal intervention

Eligible Sex

ALL

Accepts Healthy Volunteers

No