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

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

Study Overview

• Status: Recruiting
• Conditions: Congenital Diaphragmatic Hernia; Pulmonary Hypoplasia; Pulmonary; Hypertension
• Intervention / Treatment: Device: Fetal Tracheal Occlusion

Detailed Description

Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of <25%, LHR <1, or a moderate category with o/e LHR <30%, singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days (severe), gestational age < 31 weeks 6 days (moderate), no maternal disease, maternal age > 18 years old…. meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Foong-Yen Lim, MD; Phone Number: (513) 636-6259; Email: Foong-Yen.Lim@cchmc.org
• Study Contact Backup: Name: Jose Peiro, MD, PhD; Phone Number: (513) 803-4563; Email: Jose.Peiro@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center (CCHMC)
      • Contact: Foong-Yen Lim, MD; Phone Number: 513-803-5270; Email: Foong.Yen.Lim@cchmc.org
      • Contact: Jose L Peiro, MD, PhD, MBA; Phone Number: 513-803-4563; Email: jose.peiroibanez@cchmc.org
      • Sub-Investigator: Jose L Peiro, MD, MBA
      • Principal Investigator: Foong Y Lim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
• Maternal age greater than or equal to 18 years
• Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
• Normal karyotype or FISH
• Normal fetal echocardiogram
• Singleton pregnancy
• Willing to remain in the greater Cincinnati area for remainder of pregnancy
• Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
• Family meets psychosocial criteria

Exclusion Criteria:

• 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
• Bilateral CDH, isolated left sided CDH with an O/E > 30%
• Additional fetal anomaly by ultrasound, MRI, or echocardiogram
• Chromosomal abnormalities
• Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
• Incompetent cervix with or without a cerclage
• Placental abnormalities known at time of enrollment
• Maternal HIV, Hepatits B, Hepatitis C
• Maternal uterine anomaly
• No safe or technically feasible fetoscopic approach to balloon placement
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fetal Tracheal Occlusion; Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.

Device: Fetal Tracheal Occlusion; 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 as a requirement to enter the TOTAL trial.; Other Names: FETO; Fetal Endoluminal Tracheal Occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change lung growth on prenatal imaging	Change in o/eLHR and other prenatal imaging tests	prenatal period up to 40 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change survival in the severe congenital diaphragmatic hernia subgroup	Change rate of survival	6 months
Change need for ECMO therapy	Change need for ECMO therapy	6 months
Change pulmonary hypertension	Change pulmonary hypertension	6 months
Change neonatal morbidity	Change neonatal morbidity	1 year

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Study Chair: Kurt Schibler, MD, CCHMC Oversight Data Safety Monitoring Committee

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimated): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Hypertension; Hernia; Hypertension, Pulmonary; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: 2015-6413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes