Cincinnati, OHNCT07187206Now EnrollingIRB Ready

Congenital Diaphragmatic Hernia Clinical Trial in Cincinnati, OH

Access cutting-edge congenital diaphragmatic hernia treatment through this phase 3 clinical trial at a research site in Cincinnati. Study-provided care at no cost to qualified participants.

Sponsored by Children's Hospital Medical Center, Cincinnati

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Expert Care in Cincinnati

Access congenital diaphragmatic hernia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related congenital diaphragmatic hernia treatment provided free

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Check if you qualify for this congenital diaphragmatic hernia clinical trial in Cincinnati, OH

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Cincinnati

    Convenient for OH residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Cincinnati site if eligible
  4. 4Begin participation

About This Congenital Diaphragmatic Hernia Study in Cincinnati

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group

Sponsor: Children's Hospital Medical Center, Cincinnati

Who Can Participate

Inclusion Criteria

Pregnant women 18 years and older, who are able to consent
Singleton pregnancy
Gestational age at enrollment is prior to 296 weeks
Intrathoracic liver herniation
Isolated Left CDH with o/e LHR \< 30% at enrollment (180 to 295 weeks) or
Isolated Right CDH with o/e LHR \< 45% at enrollment (180 to 295 weeks)
Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure
Patient meets psychosocial criteria
Informed consent understood

Exclusion Criteria

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 prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.
Psychosocial ineligibility, precluding consent:
Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial.
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 Cincinnati Children's Hospital Medical Center.
Bilateral CDH, isolated LCDH with o/e LHR ≥ 30%, isolated RCDH with o/e LHR \> 45%, as determined by ultrasound.
No liver herniation into thoracic cavity
Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.
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 positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment.
Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cincinnati?

Yes, this clinical trial (NCT07187206) has an active research site in Cincinnati, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Congenital Diaphragmatic Hernia Treatment Options in Cincinnati, OH

If you're searching for congenital diaphragmatic hernia treatment options in Cincinnati, OH, this clinical trial (NCT07187206) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cincinnati research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced congenital diaphragmatic hernia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all congenital diaphragmatic hernia clinical trials near you to find additional studies recruiting in your area.

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