Congenital Diaphragmatic Hernia
Conditions
Brief summary
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
DEVICEBALT GOLDBALL 2 detachable latex ballon
Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
DEVICEBALTACCIBDPE100 Microcatheter
Used to deliver the detachable balloon
DEVICEStorz 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.
Sponsors
Mauro H. Schenone
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of the balloon placement procedure | Up to 29 weeks gestation | The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea. |
| Technical success of balloon retrieval procedure | Up to 34 weeks gestation | The number of successful balloon retrieval procedure defined as antenatal removal of the balloon. |
| Operative times | Up to 34 weeks gestation | FETO placement and release operative times reported in minutes |
| Frequency of unplanned balloon removal | Up to 34 weeks gestation | The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal) |
| Number of incidences of maternal complications | Up to 41 weeks gestation | Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis |
| Gestational Age at Delivery | Up to 41 weeks gestation | Gestation Age reported at time of delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Lung Growth as measured via Fetal Lung Volume | Up to 24 months post partum | Fetal Lung Volume as measured via ultrasound |
| Fetal Lung Growth as measured via LHR | Up to 24 months post partum | Lung area to head circumference Ratio (LHR) as measured via ultrasound |
| Fetal Survival | Up to 6 months post partum | Survival at 30 days, discharge from the hospital and at 6 months if still hospitalized |
| Fetal Oxygen Dependency | Up to 24 months post partum | Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician |
| Occurrence of severe pulmonary hypertension | Up to 24 months post partum | Number of occurrence of severe pulmonary hypertension in infants based on echocardiogram |
| ECMO Support | Up to 24 months post partum | Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support |
| Number of days in NICU | Up to 24 months post partum | Number of days infant was in neonatal intensive care unit |
| Number of days of ventilator support | Up to 24 months post partum | Number of reported days infants required ventilator support |
| Number of periventricular leukomalacia at < 2 months postnatally | Up to 2 months post partum | Number of infants reported presence of periventricular leukomalacia at \< 2 months postnatally |
| Number of infant complications | Up to 24 months post partum | Number of infants reporting the presence of: neonatal sepsis, intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher) or gastro-esophageal reflux |
| Use of patch or muscle flap | Up to 24 months post partum | Number of infants reported to require the use of patch or muscle flap |
| Maternal hospitalization | Up to 24 months post partum | Number of reported days of maternal hospitalization |
| Route of delivery | Day 1 (post partum) | Number of participants that delivered vaginally and via caesarean section |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMauro Schenone, MD
Mayo Clinic
Outcome results
None listed