Clinical trial for Congenital Diaphragmatic Hernia
Official title Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH
ClinicalTrials.gov ID: NCT03980717
What this study is testing
- What it's testing
- The study wants to find out whether fetal tracheal occlusion (FETO) can reduce the chance that babies with severe left‑ or right‑sided congenital diaphragmatic hernia (CDH) develop pulmonary hypertension by their first birthday.
- Who it's for
- Pregnant women whose unborn baby has been diagnosed with a severe left‑ or right‑sided CDH before birth.
- What's involved
- Participants will have a small balloon placed in the fetus’s trachea during pregnancy and removed later. The study will track the baby’s health after birth, comparing those who had the balloon to those who did not.
- Time commitment
- The procedure is done once during pregnancy, and the baby will be followed for at least one year after birth to monitor lung and heart health.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Patient is a pregnant woman between 18 and 45 years of age
- Singleton pregnancy
- The fetuses will be 28+0/7 to 31+6/7 weeks of gestational age
- Confirmed diagnosis of severe left- or right-sided CDH of the fetus: Observed/expected total lung volume equal to or less than 0.32 with more than...
- Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not...
You likely can't join if
- Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- Allergy to latex
- Allergy or previous adverse reaction to a study medication specified in this protocol
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
- Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal/neonatal survival or known syndromic...
- Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI
See the full eligibility criteria
- Patient is a pregnant woman between 18 and 45 years of age
- Singleton pregnancy
- The fetuses will be 28+0/7 to 31+6/7 weeks of gestational age
- Confirmed diagnosis of severe left- or right-sided CDH of the fetus: Observed/expected total lung volume equal to or less than 0.32 with more than 21% of liver herniated into the hemithorax.
- Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome
- Normal fetal karyotype or microarray
- The mother must be healthy enough to have surgery
- Patient and father of the baby provide signed informed consent that details the maternal and fetal risks involved with the procedure
- Patient willing to remain in Houston for the duration following balloon placement until delivery.
- Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- Allergy to latex
- Allergy or previous adverse reaction to a study medication specified in this protocol
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy.
- Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal/neonatal survival or known syndromic mutation
- Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI
- Maternal BMI \>40
- High risk for fetal hemophilia
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.