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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
Must not have
Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal/neonatal survival or known syndromic mutation
Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 years of age
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
My baby's genetic tests are normal.
Select...
I am a pregnant woman aged between 18 and 45.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My unborn baby has been diagnosed with a genetic condition that could affect survival.
Select...
I have had preterm labor, preeclampsia, or a large fibroid tumor in my current pregnancy.
Select...
I cannot undergo abdominal or fetoscopic surgery, or be put under general anesthesia.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Resolution of Pulmonary Hypertension - 12 months
Resolution of Pulmonary Hypertension - 6 months
Secondary study objectives
2-year Survival
Maternal Outcomes- Maternal Morbidity- Placental abruption
Maternal Outcomes- Maternal Morbidity- Rupture of membranes
+19 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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).
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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
1,028 Previous Clinical Trials
6,030,082 Total Patients Enrolled
Michael Belfort, MD PhDPrincipal InvestigatorBaylor College of Medicine - Texas Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My unborn baby has been diagnosed with a genetic condition that could affect survival.There are signs of a serious known syndrome on the ultrasound or MRI.I have had preterm labor, preeclampsia, or a large fibroid tumor in my current pregnancy.You are allergic to latex.Fetuses should be between 28 weeks and 31 weeks and 6 days of gestational age.My unborn baby has been diagnosed with severe CDH, with significant liver herniation and low lung volume.I am healthy enough to undergo surgery.You are pregnant with only one baby.There is a high chance that the baby could have hemophilia.The mother's body mass index (BMI) is greater than 40.I cannot undergo abdominal or fetoscopic surgery, or be put under general anesthesia.My baby's genetic tests are normal.Your baby's heart ultrasound shows no major problems or only a small issue that won't cause problems after birth, according to the heart doctor.I am a pregnant woman aged between 18 and 45.
Research Study Groups:
This trial has the following groups:- Group 1: Fetal Endotracheal Occlusion (FETO)
- Group 2: non-FETO
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.