Early FETO for Severe Congenital Diaphragmatic Hernia

Phase 2

• Conditions: Congenital Diaphragmatic Hernia
• Interventions: Other: Fetal endoscopic tracheal occlusion

• Registration Number: NCT01731509
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Detailed Description

We pretend to investigate if "early FETO" will improve the survival rate and the fetal pulmonary response, by conducting a randomized controlled trial comparing the results with those fetuses that undergo to "standard FETO" (between 26-28 weeks).

Study Timeline

• Status Verified: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-21
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2013-12-17
• Study Start: 2014-06
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Fetuses with isolated congenital diaphragmatic hernia (normal fetal karyotype and absence of any associated structural anomaly);
• Gestational age established by last menstruation and/or first trimester ultrasonography;
• Prenatal diagnosis of congenital diaphragmatic hernia before 24 weeks of gestation
• Severe congenital diaphragmatic hernia (at 24 weeks, lung-to-head ratio <1.0 and at least 1/3 of the liver herniated into the fetal thorax)
• written informed consent (by the patient)

Exclusion Criteria

• Preterm premature rupture of the membranes before randomization
• Preterm labor before randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard FETO	Fetal endoscopic tracheal occlusion	Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks.
Early FETO	Fetal endoscopic tracheal occlusion	Group of fetus that undergo fetal endoscopic tracheal occlusion between 22 0/7 weeks and 24 6/7 weeks.

Primary Outcome Measures

Name	Time	Method
Infant survival rate	6 months of life	Percentage of survivors at 6 months of life

Secondary Outcome Measures

Name	Time	Method
Postnatal severe pulmonary arterial hypertension (PAH)	30 days of life	Severe PAH will be considered when the neonate presents with profound cyanosis associated with echocardiographic continuous right-to-left shunting through a persistent 'ductus arteriosus' and a persistent difference in pre- to postductal saturation gradient \>20%, despite the use of intake Nitric Oxide (iNO).
Respiratory morbidity	6 months of life	Need for ventilatory support and/or oxygen dependency.

Trial Locations

Locations (1)

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