Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05771688

Fetoscopic Endoluminal Tracheal Occlusion

Led by Children's Hospitals and Clinics of Minnesota · Updated on 2024-02-23

10

Participants Needed

1

Research Sites

236 weeks

Total Duration

On this page

Sponsors

C

Children's Hospitals and Clinics of Minnesota

Lead Sponsor

A

Allina Health System

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.

CONDITIONS

Official Title

Fetoscopic Endoluminal Tracheal Occlusion

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older who is pregnant
  • Singleton pregnancy
  • Diagnosis of severe left-sided congenital diaphragmatic hernia (CDH) with Observed to Expected Lung to Head Ratio (O/E LHR) less than 25% by ultrasound
  • No lethal anomalies other than CDH and no pathogenic genetic findings
  • Fetal echocardiogram shows changes expected with CDH and no major structural heart defects
  • Gestational age between 27 weeks 0 days and 29 weeks 6 days at time of balloon placement
  • Cervix length longer than 20 mm before balloon placement
  • Willingness to stay locally within 15 minutes of Midwest Fetal Care Center and Children's Minnesota
  • Written informed consent obtained
  • Meets psychosocial criteria including having family or friend support during balloon placement, no current illicit drug use, no abuse of over-the-counter drugs, and no untreated serious psychiatric diagnoses
Not Eligible

You will not qualify if you...

  • Multiple pregnancy (twins or higher order gestation)
  • Unable to give consent
  • Right-sided or bilateral congenital diaphragmatic hernia
  • Additional fetal or genetic abnormalities that affect care or outcome
  • Maternal isoimmunization or neonatal alloimmune thrombocytopenia
  • Balloon placement not possible before 30 weeks gestation
  • CDH O/E LHR 25% or greater
  • Maternal conditions preventing safe fetal surgery (unsafe cardiac findings, morbid obesity, spontaneous preterm delivery before 36 weeks)
  • Maternal HIV, Hepatitis B with positive surface antigen, or Hepatitis C with active virus
  • Cervix length 20 mm or less
  • History of incompetent cervix or uterine abnormalities increasing preterm labor risk
  • Significant placental abnormalities known at enrollment or surgery
  • History of natural rubber latex allergy
  • No safe or feasible fetoscopic approach for balloon placement
  • Unable to relocate within 15 minutes of Midwest Fetal Care Center/Children's Minnesota

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Midwest Fetal Care Center

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

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Research Team

J

James E Fisher, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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