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

Primary Purpose

Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary; Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fetal Tracheal Occlusion
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Diaphragmatic Hernia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center (CCHMC)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fetal Tracheal Occlusion

Arm Description

Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.

Outcomes

Primary Outcome Measures

Change lung growth on prenatal imaging
Change in o/eLHR and other prenatal imaging tests

Secondary Outcome Measures

Change survival in the severe congenital diaphragmatic hernia subgroup
Change rate of survival
Change need for ECMO therapy
Change need for ECMO therapy
Change pulmonary hypertension
Change pulmonary hypertension
Change neonatal morbidity
Change neonatal morbidity

Full Information

First Posted
December 6, 2016
Last Updated
July 5, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02986087
Brief Title
Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia
Acronym
FETO
Official Title
Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary; Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fetal Tracheal Occlusion
Arm Type
Experimental
Arm Description
Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.
Intervention Type
Device
Intervention Name(s)
Fetal Tracheal Occlusion
Other Intervention Name(s)
FETO, Fetal Endoluminal Tracheal Occlusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change lung growth on prenatal imaging
Description
Change in o/eLHR and other prenatal imaging tests
Time Frame
prenatal period up to 40 weeks gestation
Secondary Outcome Measure Information:
Title
Change survival in the severe congenital diaphragmatic hernia subgroup
Description
Change rate of survival
Time Frame
6 months
Title
Change need for ECMO therapy
Description
Change need for ECMO therapy
Time Frame
6 months
Title
Change pulmonary hypertension
Description
Change pulmonary hypertension
Time Frame
6 months
Title
Change neonatal morbidity
Description
Change neonatal morbidity
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Foong-Yen Lim, MD
Phone
(513) 636-6259
Email
Foong-Yen.Lim@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Peiro, MD, PhD
Phone
(513) 803-4563
Email
Jose.Peiro@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Schibler, MD
Organizational Affiliation
CCHMC Oversight Data Safety Monitoring Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center (CCHMC)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Foong-Yen Lim, MD
Phone
513-803-5270
Email
Foong.Yen.Lim@cchmc.org
First Name & Middle Initial & Last Name & Degree
Jose L Peiro, MD, PhD, MBA
Phone
513-803-4563
Email
jose.peiroibanez@cchmc.org
First Name & Middle Initial & Last Name & Degree
Jose L Peiro, MD, MBA
First Name & Middle Initial & Last Name & Degree
Foong Y Lim, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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