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Early FETO for Severe Congenital Diaphragmatic Hernia

NCT01731509 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-12-17

No results posted yet for this study

Summary

Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in those cases with severe forms where there are extremely reduced lung volumes, liver herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal pulmonary response followed FETO can be used to predict outcome and is dependent on the size of the fetal lung prior to the procedure.

We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form of CDH will have a better fetal pulmonary response and higher chance of surviving.

Conditions

  • Congenital Diaphragmatic Hernia

Interventions

OTHER

Fetal endoscopic tracheal occlusion

FETO will be performed by placing a detachable balloon inside fetal trachea

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • 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
NONE
Model
PARALLEL

Eligibility

Min Age
22 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

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 NCT01731509 on ClinicalTrials.gov