Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Official title

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia

Overview

The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).

Interventions

• Device BALT GOLDBALL 2 detachable latex ballon
  Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
• Device BALTACCIBDPE100 Microcatheter
  Used to deliver the detachable balloon
• Device Storz fetoscopic operating sheath and miniature telescope/fetoscope
  Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.

Primary outcome measures

• Technical success of the balloon placement procedure [Time frame: Up to 29 weeks gestation]
• Technical success of balloon retrieval procedure [Time frame: Up to 34 weeks gestation]
• Operative times [Time frame: Up to 34 weeks gestation]
• Frequency of unplanned balloon removal [Time frame: Up to 34 weeks gestation]
• Number of incidences of maternal complications [Time frame: Up to 41 weeks gestation]
• Gestational Age at Delivery [Time frame: Up to 41 weeks gestation]

Secondary outcome measures (12)

• Fetal Lung Growth as measured via Fetal Lung Volume [Time frame: Up to 24 months post partum]
• Fetal Lung Growth as measured via LHR [Time frame: Up to 24 months post partum]
• Fetal Survival [Time frame: Up to 6 months post partum]
• Fetal Oxygen Dependency [Time frame: Up to 24 months post partum]
• Occurrence of severe pulmonary hypertension [Time frame: Up to 24 months post partum]
• ECMO Support [Time frame: Up to 24 months post partum]
• Number of days in NICU [Time frame: Up to 24 months post partum]
• Number of days of ventilator support [Time frame: Up to 24 months post partum]
• Number of periventricular leukomalacia at < 2 months postnatally [Time frame: Up to 2 months post partum]
• Number of infant complications [Time frame: Up to 24 months post partum]
• Use of patch or muscle flap [Time frame: Up to 24 months post partum]
• Maternal hospitalization [Time frame: Up to 24 months post partum]

Eligibility criteria

Inclusion criteria

• Singleton pregnancy
• Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
• Isolated severe left CDH with O/E LHR < 25% )
• Gestation age at enrollment prior to 29 wks plus 6 days.
• Pulmonary hypoplasia with ultrasound O/E LHR < 25% (measured at 18 0/7 to 29 5/7 weeks) at the time of surgery.
• Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
• Patient meets psychosocial criteria: able to reside within 30 minutes of Mayo Clinic, Rochester and able to comply with the travel for the follow-up requirements of the trial; patient has a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic
• Patient is willing and able to give informed consent
• Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT)

Exclusion criteria

• Multi-fetal pregnancy
• History of natural rubber latex allergy
• Preterm labor, cervix shortened (<20 mm) at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor
• Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes of Mayo Clinic, Rochester 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 Mayo Clinic
• Right sided CDH or bilateral CDH, isolated left sided with O/E LHR >25% measured at 18 0/7 to 29 6/7 weeks) as determined by ultrasound
• Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
• Maternal contraindication to fetoscopic surgery
• 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 status positive.
• Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality that will make the procedure technically unfeasible
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Mayo Clinic Minnesota — Rochester

Identifiers

NCT: NCT05962346 · 23-002166

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗