Health TrialsbyHealthPanel

Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

ConditionsCongenital Diaphragmatic HerniaPulmonary HypoplasiaPulmonary; Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Isolated CDH with liver up

Severe pulmonary hypoplasia with ultrasound O/E LHR <25% at the time of surgery

Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days

Moderate pulmonary hypoplasia with ultrasound O/E LHR <30% and liver-up at the time of surgery

Disqualifiers

Patient < 18 years old

Multi-fetal pregnancy

Rubber latex allergy

Preterm labor, cervix shortened (<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa

Trial design

Design model

Single group

Treatments tested in this trial

  • Fetal Tracheal Occlusion

    Device

    Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of \<25%, LHR \<1, o/e LHR\<30% (moderate), singleton pregnancy, no known other anomalies, gestational age \< 29 weeks 6 days, no maternal disease, maternal age \> 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Fetal Tracheal OcclusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change lung growth on prenatal imaging

Change in o/eLHR and other prenatal imaging tests

Time frame
prenatal period up to 40 weeks gestation

Secondary outcomes

1

Change survival in the severe congenital diaphragmatic hernia subgroup

Change rate of survival

Time frame
6 months
2

Change need for ECMO therapy

Change need for ECMO therapy

Time frame
6 months
3

Change pulmonary hypertension

Change pulmonary hypertension

Time frame
6 months
4

Change neonatal morbidity

Change neonatal morbidity

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Source ClinicalTrials.gov
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