Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH) (FETO)

STATUS

Recruiting
End date

Apr 21, 2024
participants needed

10
sponsor

Dr Erin Perrone

Updated on 28 February 2022

See if I qualify

diaphragmatic hernia

pulmonary hypoplasia

Summary

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.

Details

Condition	Congenital Diaphragmatic Hernia
Treatment	FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
Clinical Study Identifier	NCT04052828
Sponsor	Dr Erin Perrone
Last Modified on	28 February 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Signed and dated consent
	Stated willingness to comply with all study procedures and availability for the duration of the study
	Singleton pregnancy
	No pathogenic variants on microarray or pathologic findings on karyotype
	Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
	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
	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
	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

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Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH) (FETO)