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Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial

NCT01302977 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-02-24

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Diaphragmatic Hernia
  • Congenital Abnormality

Interventions

PROCEDURE

Fetal tracheal occlusion

Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Rodrigo Ruano, MD, PhD · Faculdade de Medicina da Universidade de Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302977 on ClinicalTrials.gov