Early FETO for Severe Congenital Diaphragmatic Hernia

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 2

Conditions: Congenital Diaphragmatic Hernia

Treatments: Other: Fetal endoscopic tracheal occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01731509

8353/12

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 estimated patients

Sex: All

Ages: 22 to 28 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Standard FETO

Active Comparator group

Description:

Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks.

Treatment:

Other: Fetal endoscopic tracheal occlusion

Early FETO

Experimental group

Description:

Group of fetus that undergo fetal endoscopic tracheal occlusion between 22 0/7 weeks and 24 6/7 weeks.

Treatment:

Other: Fetal endoscopic tracheal occlusion