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Tests treatment safety and results for Congenital Diaphragmatic Hernia
Official title Safety and Efficacy of FETO in CDH: A Phase III Trial
ClinicalTrials.gov ID: NCT06884423
What this study is testing
- What it's testing
- Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pregnant women age 18 years and older
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results, whole exome sequencing (WES), whole genome sequencing (WGS), or chromosomal microarray...
- Gestational age at enrollment is prior to 29 weeks 6 days
- Liver is intrathoracic
You likely can't join if
- Patient is less than 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (less than 20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly...
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minutes of the Children's Hospital of Philadelphia (CHOP) and inability to comply with the travel for the follow-up...
See the full eligibility criteria
- Pregnant women age 18 years and older
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results, whole exome sequencing (WES), whole genome sequencing (WGS), or chromosomal microarray with non-pathologic variants. Results by fluorescence in situ...
- Gestational age at enrollment is prior to 29 weeks 6 days
- Liver is intrathoracic
- Isolated left congenital diaphragmatic hernia (CDH) with observed/expected lung to head ratio (O/E LHR) of less than 30% at enrollment (18\^0 to 29\^5 weeks), or:
- Isolated right CDH with O/E LHR equal to or less than 45% at enrollment (18\^0 to 29\^5 weeks).
- Cervical length by transvaginal ultrasound equal to or greater than 20 mm within 24 hours of fetoscopic endoluminal tracheal occlusion (FETO) procedure
- Patient meets psychosocial criteria
- Informed consent
- Patient is less than 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (less than 20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minutes of the Children's Hospital of Philadelphia (CHOP) and inability to comply with the travel for the follow-up requirements of the trial
- Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at CHOP
- Bilateral CDH, isolated left sided CDH with O/E LHR greater than or equal to 30% (measured at 18\^0 to 29\^5 weeks), isolated right sided CDH with O/E LHR greater than 45% (measured at 180 to 295 weeks), as determined...
- No Liver herniation into thoracic cavity.
- Additional fetal anomaly by ultrasound, magnetic resonance imaging (MRI), or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis...
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accrete) known at time of enrollment.
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be...
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
- There is 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.