ACTIVE_NOT_RECRUITING

Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to determine the infant survival and long-term effects of performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of the BALT Goldbal2 balloon at Children's Mercy Hospital. We hypothesize that FETO balloon placement may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe left or right congenital diaphragmatic hernia (CDH).

Official Title

Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial

Quick Facts

Study Start:2024-04-14

Study Completion:2032-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06179472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study * Pregnant persons age 18 years and older * Singleton pregnancy * Absence of life-limiting genetic anomalies on microarray or karyotype on amniocentesis. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks gestation * Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects (small ventricular septal defect (VSD)/atrial septal defect (ASD) may be included as they will not alter outcome and are not life-limiting) * Left or Right CDH with liver up without presence of concomitant life-limiting anomalies. * Gestational age for Left-CDH at enrollment prior to 29 weeks plus 6 days for O/E LHR \<30%; for Right-CDH with O/E LHR \<45% gestational age at enrollment prior to 29 weeks plus 6 days. * Meets psychosocial criteria * Willing to reside within 30 minutes of Children's Mercy Hospital Fetal Health Center and ability to maintain follow up appointments * Patient has a support person (e.g. spouse, partner, friend, or parent) that is available to stay with her for the duration of the pregnancy. * Willing to comply with restrictions of daily living including inability to exercise, have intercourse or return to work.	* Pregnant persons \< 18 years of age * Multi-fetal pregnancy * Rubber latex allergy * History of preterm labor, cervix shortened (\<15mm 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 Children's Mercy Hospital Fetal Health Center until balloon removal or delivery (if clinically indicated) * Patient does not have a support person (e.g., spouse, partner, parent) available to stay with the patient until balloon removal or duration of the pregnancy (if clinically indicated) * Adult unable to consent * Prisoners * Social work or health psychology will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude the patient as a potential candidate. * Bilateral CDH, isolated left-sided with O/E LHR ≥30% (measured at 18 weeks 0 days to 29 weeks 5 days) as determined by ultrasound, isolated right-sided CDH with O/E LHR ≥45% (measured at 18 years 0 days to 29 weeks 5 days) as determined by ultrasound. * Additional life-limiting fetal anomaly by ultrasound, MRI or echocardiogram that may affect outcome. These include chromosomal or anatomic abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and severe congenital heart disease) or presence of an underlying genetic syndrome (e.g., Fryns). No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring. * Patient contraindication to fetoscopic surgery or severe medical condition in pregnancy * History of incompetent cervix with or without cerclage * Placental abnormalities (previa, abruption, accreta) known at the time of enrollment * Pregnant person-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy * Pregnant person tests positive for HIV, Hepatitis-B, Hepatitis-C. Due to of the increased risk of transmission to the fetus during maternal-fetal surgery the patient must test negative for these conditions prior to enrollment. * 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. * Patient refusal to receive blood products * Additional major anomaly or abnormality that would prevent successful FETO, per discretion of the Principal Investigator

Inclusion Criteria

Exclusion Criteria

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
* Pregnant persons age 18 years and older
* Singleton pregnancy
* Absence of life-limiting genetic anomalies on microarray or karyotype on amniocentesis. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks gestation
* Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects (small ventricular septal defect (VSD)/atrial septal defect (ASD) may be included as they will not alter outcome and are not life-limiting)
* Left or Right CDH with liver up without presence of concomitant life-limiting anomalies.
* Gestational age for Left-CDH at enrollment prior to 29 weeks plus 6 days for O/E LHR \<30%; for Right-CDH with O/E LHR \<45% gestational age at enrollment prior to 29 weeks plus 6 days.
* Meets psychosocial criteria
* Willing to reside within 30 minutes of Children's Mercy Hospital Fetal Health Center and ability to maintain follow up appointments
* Patient has a support person (e.g. spouse, partner, friend, or parent) that is available to stay with her for the duration of the pregnancy.
* Willing to comply with restrictions of daily living including inability to exercise, have intercourse or return to work.

* Pregnant persons \< 18 years of age
* Multi-fetal pregnancy
* Rubber latex allergy
* History of preterm labor, cervix shortened (\<15mm 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 Children's Mercy Hospital Fetal Health Center until balloon removal or delivery (if clinically indicated)
* Patient does not have a support person (e.g., spouse, partner, parent) available to stay with the patient until balloon removal or duration of the pregnancy (if clinically indicated)
* Adult unable to consent
* Prisoners
* Social work or health psychology will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude the patient as a potential candidate.
* Bilateral CDH, isolated left-sided with O/E LHR ≥30% (measured at 18 weeks 0 days to 29 weeks 5 days) as determined by ultrasound, isolated right-sided CDH with O/E LHR ≥45% (measured at 18 years 0 days to 29 weeks 5 days) as determined by ultrasound.
* Additional life-limiting fetal anomaly by ultrasound, MRI or echocardiogram that may affect outcome. These include chromosomal or anatomic abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and severe congenital heart disease) or presence of an underlying genetic syndrome (e.g., Fryns). No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring.
* Patient contraindication to fetoscopic surgery or severe medical condition in pregnancy
* History of incompetent cervix with or without cerclage
* Placental abnormalities (previa, abruption, accreta) known at the time of enrollment
* Pregnant person-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
* Pregnant person tests positive for HIV, Hepatitis-B, Hepatitis-C. Due to of the increased risk of transmission to the fetus during maternal-fetal surgery the patient must test negative for these conditions prior to enrollment.
* 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.
* Patient refusal to receive blood products
* Additional major anomaly or abnormality that would prevent successful FETO, per discretion of the Principal Investigator

Contacts and Locations

Principal Investigator

Inna Lobeck

PRINCIPAL_INVESTIGATOR

Physician

Study Locations (Sites)

Children's Mercy Hospital

Kansas City, Missouri, 64108

United States

Collaborators and Investigators

Sponsor: Children's Mercy Hospital Kansas City

Inna Lobeck, PRINCIPAL_INVESTIGATOR, Physician

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-14

Study Completion Date2032-01-01

Study Record Updates

Study Start Date2024-04-14

Study Completion Date2032-01-01

Terms related to this study

Additional Relevant MeSH Terms

Congenital Diaphragmatic Hernia