RECRUITING

Safety and Efficacy of FETO in CDH: a Phase III Trial

Conditions

Congenital Diaphragmatic Hernia Pulmonary Hypoplasia tracheal occlusion

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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

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. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.

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:2025-03

Study Completion:2032-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06884423

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

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Pregnant women age 18 years and older 2. Singleton pregnancy 3. 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 hybridization (FISH) will be acceptable if the patient is greater than 26 weeks. 4. Gestational age at enrollment is prior to 29 weeks 6 days 5. Liver is intrathoracic 6. 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: 7. Isolated right CDH with O/E LHR equal to or less than 45% at enrollment (18\^0 to 29\^5 weeks). 8. Cervical length by transvaginal ultrasound equal to or greater than 20 mm within 24 hours of fetoscopic endoluminal tracheal occlusion (FETO) procedure 9. Patient meets psychosocial criteria 10. Informed consent	1. Patient is less than 18 years of age 2. Multi-fetal pregnancy 3. History of natural rubber latex allergy 4. 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 5. 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 6. 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 by ultrasound 7. No Liver herniation into thoracic cavity. 8. 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 (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns). No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring. 9. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy 10. History of incompetent cervix with or without cerclage 11. Placental abnormalities (previa, abruption, accrete) known at time of enrollment. 12. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy. 13. 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 tested and found to have negative results before enrollment. 14. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality 15. There is no safe or technically feasible fetoscopic approach to balloon placement. 16. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.

Inclusion Criteria

Exclusion Criteria

1. Pregnant women age 18 years and older
2. Singleton pregnancy
3. 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 hybridization (FISH) will be acceptable if the patient is greater than 26 weeks.
4. Gestational age at enrollment is prior to 29 weeks 6 days
5. Liver is intrathoracic
6. 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:
7. Isolated right CDH with O/E LHR equal to or less than 45% at enrollment (18\^0 to 29\^5 weeks).
8. Cervical length by transvaginal ultrasound equal to or greater than 20 mm within 24 hours of fetoscopic endoluminal tracheal occlusion (FETO) procedure
9. Patient meets psychosocial criteria
10. Informed consent

1. Patient is less than 18 years of age
2. Multi-fetal pregnancy
3. History of natural rubber latex allergy
4. 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
5. 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
6. 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 by ultrasound
7. No Liver herniation into thoracic cavity.
8. 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 (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns). No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring.
9. Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
10. History of incompetent cervix with or without cerclage
11. Placental abnormalities (previa, abruption, accrete) known at time of enrollment.
12. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
13. 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 tested and found to have negative results before enrollment.
14. Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
15. There is no safe or technically feasible fetoscopic approach to balloon placement.
16. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.

Contacts and Locations

Study Contact

Holly L Hedrick, MD, FACS

CONTACT

1-800-468-8376

hedrick@chop.edu

Annaliese Aarthun

CONTACT

aarthuna@chop.edu

Principal Investigator

Holly L Hedrick, MD, FACS

PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Holly L Hedrick, MD

Holly L Hedrick, MD, FACS, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

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 Date2025-03

Study Completion Date2032-03

Study Record Updates

Study Start Date2025-03

Study Completion Date2032-03

Terms related to this study

Keywords Provided by Researchers

congenital diaphragmatic hernia
tracheal occlusion

Additional Relevant MeSH Terms

Congenital Diaphragmatic Hernia
Pulmonary Hypoplasia