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New treatment option for Congenital Diaphragmatic Hernia
Official title Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH
ClinicalTrials.gov ID: NCT07166172
What this study is testing
- What it's testing
- This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.
- Time commitment: about 24 months
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 Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, whole exome sequencing (WES) or whole genome sequencing (WGS)...
- Gestational age at enrollment is prior to 29 weeks + 6 days gestation.
- Intrathoracic liver herniation:
You likely can't join if
- Patient \< 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (\<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 Johns Hopkins Hospital Center for Fetal Therapy.
See the full eligibility criteria
- Pregnant women age 18 years and older
- Singleton pregnancy
- Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, whole exome sequencing (WES) or whole genome sequencing (WGS). Results by fluorescence in situ hybridization (FISH) will be acceptable if...
- Gestational age at enrollment is prior to 29 weeks + 6 days gestation.
- Intrathoracic liver herniation:
- Isolated left CDH with o/e LHR \< 30% at enrollment (18wks + 0 days to 29wks + 5 days gestation).
- Isolated right CDH with o/e LHR ≤ 45% at enrollment (18wks + 0 days to 29wks + 5 days gestation).
- Cervical length by transvaginal ultrasound ≥ 20 mm within 24 hours prior to FETO procedure.
- Patient meets psychosocial criteria.
- Informed consent understood.
- Patient \< 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (\<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 Johns Hopkins Hospital Center for Fetal Therapy.
- The 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 Johns Hopkins Hospital Center for Fetal Therapy.
- Bilateral CDH, isolated left sided CDH with O/E LHR ≥ 30% (18wks + 0 days to 29wks + 5 days gestation), isolated right sided CDH with O/E LHR \> 45% (18wks + 0 days to 29wks + 5 days gestation), as determined by...
- No liver herniation into thoracic cavity.
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, 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, accreta) 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 anomalies 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
- Baltimore, Maryland, 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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Baltimore, Maryland, 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.