Onderzoek naar foetale endoscopische tracheale occlusie (FETO) voor congenitale hernia diafragmatica (CDH) (FETO)
Onderzoek naar foetale endoscopische tracheale occlusie voor congenitale hernia diafragmatica (CDH)
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at Michigan Medicine.
This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
This study has concluded and the second FETO trial (NCT07577414) has begun enrolling participants.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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Signed and dated consent
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Stated willingness to comply with all study procedures and availability for the duration of the study
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Singleton pregnancy
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No pathogenic variants on microarray or pathologic findings on karyotype
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Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
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Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as observed-to-expected (o/e) lung to head ratios (LHR) <25% with liver up
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Gestational age at FETO procedure: if o/e LHR <25% will be done at 27 weeks plus 0 days to 29 weeks plus 6 days
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Meets psychosocial criteria
- Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments
- Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near Von Voigtlander Women's Hospital
- Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work.
Exclusion Criteria:
- Multi-fetal pregnancy
- History of latex allergy
- History of preterm labor or incompetent cervix (requiring cerclage), short cervix (≤20mm), or uterine anomaly predisposing to preterm labor
- Bilateral CDH, unilateral CDH with o/e LHR > 25%, or unilateral CDH with o/e LHR <25% but liver completely down in abdomen
- Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
- Maternal contraindications to elective fetoscopic surgery
- Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
- Maternal isoimmunization or neonatal alloimmune thrombocytopenia
- Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
- No safe or feasible fetoscopic approach to balloon placement
- Social work 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 her as a potential candidate.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: FETO with GOLDBAL2
A balloon will be placed in the airway of the fetus during the FETO procedure. |
This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants With Successful Placement of the Goldballoon Detachable Balloon (GOLDBAL2) at Gestational Age 27 Weeks Zero Days (27w0d) to 29 Weeks and 6 Days (29w6d) Gestation.
Tijdsspanne: Between 27 weeks 0 days and 29 week 6 days of gestation, within 1 week of enrollment
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Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure. |
Between 27 weeks 0 days and 29 week 6 days of gestation, within 1 week of enrollment
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Number of Participants With Successful Retrieval of the GOLDBAL2
Tijdsspanne: Removal prior to delivery approximately 34 weeks of gestation (up to approximately 8 weeks post enrollment) or at delivery on placental bypass (up to approximately 14 weeks post enrollment)
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This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery. Alternatively, it could occur on placental bypass. |
Removal prior to delivery approximately 34 weeks of gestation (up to approximately 8 weeks post enrollment) or at delivery on placental bypass (up to approximately 14 weeks post enrollment)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Observed to Expected Total Fetal Lung Volume (o/e TFLV) on Prenatal Magnetic Resonance Imaging (MRI)
Tijdsspanne: baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval (approximately 11 weeks post enrollment)
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Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval. Observed to expected total fetal lung volume (o/e TFLV) is the percentage of lung volume a fetus has compared to the expected lung volume for a fetus at the same gestational age. It is calculated by dividing the observed TFLV by the expected TFLV and multiplying by 100 to get a percent. This outcome measure is the median change in o/e TFLV between the MRIs. |
baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval (approximately 11 weeks post enrollment)
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Change in Fetal Lung Growth
Tijdsspanne: baseline (before balloon placement), immediately prior to balloon removal (up to approximately 14 weeks post enrollment)
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Fetal ultrasounds will be done weekly while the balloon is in place. Fetal lung growth will be calculated as the difference between the observed to expected Lung to Head Ratio (o/e LHR) pre-balloon placement and the o/e LHR immediately prior to balloon removal. O/e LHR uses the area of the lung opposite of the diaphragmatic hernia divided by head circumference to get a lung to head ratio. The observed to expected lung to head ratio is the lung to head ratio divided by the expected lung to head ratio at that gestational age multiplied by 100 to get a percent. This outcome measure describes the change in o/e LHR. |
baseline (before balloon placement), immediately prior to balloon removal (up to approximately 14 weeks post enrollment)
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Gestational Age at Delivery
Tijdsspanne: At the time of delivery (up to approximately 14 weeks post enrollment)
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At the time of delivery (up to approximately 14 weeks post enrollment)
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Survival of Infant to Hospital Discharge or 180 Days After Hospitalized
Tijdsspanne: Discharge from hospital or up to 180 days in the hospital (up to approximately 40 weeks post enrollment)
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This will be measured after the infant is delivered to hospital discharge or analyzed for survival at 180 days for those still hospitalized at that time point. |
Discharge from hospital or up to 180 days in the hospital (up to approximately 40 weeks post enrollment)
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Number of Participants With Maternal Complications
Tijdsspanne: up to 4-8 weeks postpartum (up to approximately 22 weeks post enrollment)
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Complications during pregnancy, and/or at delivery and follow-up to include; preterm labor, premature rupture of membranes (PROM), Preterm Premature Rupture of Membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamniotic separation, chorioamnionitis, and other infection. In results, patients who experience PPROM are also counted for PROM. |
up to 4-8 weeks postpartum (up to approximately 22 weeks post enrollment)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Erin Perrone, MD, University of Michigan
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HUM00159792
Plan Individuele Deelnemersgegevens (IPD)
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