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Procedure

FETO for Congenital Diaphragmatic Hernia

N/A

Recruiting

Led By Michael Belfort, MD PhD

Research Sponsored by Michael A Belfort

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal fetal karyotype or microarray

Patient is a pregnant woman between 18 and 45 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 years of age

Awards & highlights

Study Summary

This trial is being done to study a fetal surgery called FETO to see if it can help babies with congenital diaphragmatic hernia (CDH).

Who is the study for?

This trial is for pregnant women aged 18-45 with a single pregnancy and a fetus diagnosed with severe left or right-sided CDH. The fetus should be between 28 to almost 32 weeks old, have normal heart function or minor issues not affecting outcome, and the mother must stay in Houston post-procedure until delivery. Exclusions include latex allergy, surgery risks, fetal genetic anomalies impacting survival, maternal BMI over 40, or high risk of fetal hemophilia.Check my eligibility

What is being tested?

The study tests FETO using a balloon device inserted fetoscopically to treat severe congenital diaphragmatic hernia (CDH) in fetuses. It aims to improve lung development and resolve pulmonary hypertension by comparing outcomes of 40 FETO procedures against non-FETO cases due to medical/social reasons.See study design

What are the potential side effects?

Potential side effects may include complications from abdominal surgery such as infection or bleeding; adverse reactions related to the balloon device like displacement; general anesthesia risks; preterm labor; and specific risks detailed in informed consent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby's genetic tests are normal.

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I am a pregnant woman aged between 18 and 45.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 years of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 years of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 years of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Resolution of Pulmonary Hypertension - 12 months

Resolution of Pulmonary Hypertension - 6 months

Secondary outcome measures

2-year Survival

Maternal Outcomes- Maternal Morbidity- Placental abruption

Maternal Outcomes- Maternal Morbidity- Rupture of membranes

+19 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Fetal Endotracheal Occlusion (FETO)Experimental Treatment1 Intervention

Placement and retrieval of the GoldBAL4 or GoldBAL2 Detachable balloon using the plug/unplug method, using BALTACCIDBPE100 Delivery Catheter.

Group II: non-FETOActive Control1 Intervention

The control group will consist of patients who did not undergo the FETO procedure who fit the same fetal inclusion/exclusion criteria as our FETO subjects and will be matched by variables including maternal age, body mass index, gestational age, severity of CDH and site of CDH (left- or right-sided).

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Michael A BelfortLead Sponsor

4 Previous Clinical Trials

425 Total Patients Enrolled

Baylor College of MedicineOTHER

1,001 Previous Clinical Trials

6,002,172 Total Patients Enrolled

Michael Belfort, MD PhDPrincipal InvestigatorBaylor College of Medicine - Texas Children's Hospital

Media Library

Fetal Endotracheal Occlusion (FETO) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03980717 — N/A

Congenital Diaphragmatic Hernia Research Study Groups: Fetal Endotracheal Occlusion (FETO), non-FETO

Congenital Diaphragmatic Hernia Clinical Trial 2023: Fetal Endotracheal Occlusion (FETO) Highlights & Side Effects. Trial Name: NCT03980717 — N/A

Fetal Endotracheal Occlusion (FETO) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03980717 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals of this clinical trial?

"This medical trial, with a span of 6 months and an end-point of Resolution of Pulmonary hypertension within 12 months, aims to measure Maternal Outcomes such as Placental Abruption by reviewing Case Report Forms. Additionally, Neonatal/Child outcomes including the need for Supplemental Oxygen and success rate in surgical procedures or balloon placement will be tracked via CRFs. Fetal surveillance post procedure is conducted bimonthly for up to 10 weeks following balloon insertion."

Answered by AI

Are there vacancies for participants in this investigation?

"Affirmative. Clinicaltrials.gov documents that this medical trial was posted on August 9th 2019 and updated most recently on April 2nd 2022, with recruitment of 80 patients at 1 site currently underway."

Answered by AI

Is this research endeavor accommodating individuals aged 80 and above?

"To be included in this medical trial, participants must between 18 and 45 years old. Separately, there are 73 clinical trials for minors and 805 studies specifically tailored to seniors."

Answered by AI

Am I a viable candidate for this experiment?

"To qualify for participation in this study, patients must have been diagnosed with a Morgagni hernia and be between 18 to 45 years old. This trial is looking to enrol 80 individuals."

Answered by AI

How many individuals are currently participating in this medical experiment?

"Affirmative. According to data on clinicaltrials.gov, this research initiative, which was initially posted on August 9th 2019, is currently recruiting patients. Around 80 participants must be enrolled from 1 particular site."

Answered by AI

Recent research and studies

in UteroJournal

Prenatal Diagnosis, Prediction of Outcome And<i>in Utero</i>therapy of Isolated Congenital Diaphragmatic Hernia

Doné, Elisa, Leonardo Gucciardo, Tim Van Mieghem, Jacques Jani, Mieke Cannie, Dominique Van Schoubroeck, Roland Devlieger, et al.. 2008. “Prenatal Diagnosis, Prediction of Outcome Andin Uterotherapy of Isolated Congenital Diaphragmatic Hernia”. Prenatal Diagnosis. Wiley. doi:10.1002/pd.2033.

Seminars in PerinatologyJournal

Fetal Intervention for Congenital Diaphragmatic Hernia: The European Experience

Deprest, Jan, Jacques Jani, Eduardo Gratacos, Hilde Vandecruys, Gunnar Naulaers, Julian Delgado, Anne Greenough, and Kypros Nicolaides. 2005. “Fetal Intervention for Congenital Diaphragmatic Hernia: The European Experience”. Seminars in Perinatology. Elsevier BV. doi:10.1053/j.semperi.2005.04.006.

Prenatal DiagnosisJournal

Current Controversies in Prenatal Diagnosis 4: Should Fetal Surgery Be Done in All Cases of Severe Diaphragmatic Hernia?

Deprest, J. A., J. A. Hyett, A. W. Flake, K. Nicolaides, and E. Gratacos. 2009. “Current Controversies in Prenatal Diagnosis 4: Should Fetal Surgery Be Done in All Cases of Severe Diaphragmatic Hernia?”. Prenatal Diagnosis. Wiley. doi:10.1002/pd.2108.

Ultrasound in Obstetrics & GynecologyJournal