Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial

Phase 2

• Conditions: Congenital Diaphragmatic Hernia; Congenital Abnormality
• Interventions: Procedure: Fetal tracheal occlusion

• Registration Number: NCT01302977
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed Description

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).

Study Timeline

• Study Start: 2008-05
• Status Verified: 2011-02
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-23
• Last Update Submitted: 2011-02-23
• Study First Posted: 2011-02-24
• Last Update Posted: 2011-02-24
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fetal intervention	Fetal tracheal occlusion	Composed of fetuses that undergo to fetal tracheal occlusion at 26-28 weeks.

Primary Outcome Measures

Name	Time	Method
Survival rate	1 year	Noenatal survival rate which includes percentage of newborns that survive up to 30 days of life.; Infant survival rate which includes percentage of newborns that survive up to one year of life. Outcome measurement will be assessed up to one year after birth.

Secondary Outcome Measures

Name	Time	Method
Postnatal pulmonary arterial hypertension	30 days of life	Postnatal pulmonary arterial hypertension will be assessed up to 30 days of life according to the echocardiographic findings.

Trial Locations

Locations (1)

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo; 🇧🇷 Sao Paulo, Brazil