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

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT02986087
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
121
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Fetal Tracheal Occlusion
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change lung growth on prenatal imaging [prenatal period up to 40 weeks gestation]

      Change in o/eLHR and other prenatal imaging tests

    Secondary Outcome Measures

    1. Change survival in the severe congenital diaphragmatic hernia subgroup [6 months]

      Change rate of survival

    2. Change need for ECMO therapy [6 months]

      Change need for ECMO therapy

    3. Change pulmonary hypertension [6 months]

      Change pulmonary hypertension

    4. Change neonatal morbidity [1 year]

      Change neonatal morbidity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    • Right sided CDH, 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Medical Center (CCHMC) Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati

    Investigators

    • Study Chair: Kurt Schibler, MD, CCHMC Oversight Data Safety Monitoring Committee

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT02986087
    Other Study ID Numbers:
    • 2015-6413
    First Posted:
    Dec 8, 2016
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Hernias, Diaphragmatic, Congenital
    Hernia
    Hernia, Diaphragmatic

    Study Results

    No Results Posted as of Nov 3, 2021