Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/10/2018 |
| Start Date: | August 2015 |
| End Date: | July 2019 |
| Contact: | Ahmet A Baschat, MD |
| Email: | abascha1@JHMI.edu |
| Phone: | 443 287 9549 |
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe Left Congenital Diaphragmatic Hernia (CDH)
Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal
membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that
minimize ventilator-induced lung injury, morbidity and mortality rates for babies with
congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of
prenatal lung compression and the subsequent impairment of pulmonary function following
delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate
the severity by relating the circumference of the lung contralateral to the hernia to the
fetal head circumference lung to head ratio (LHR) and by noting the degree of upward
herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR),
prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While
overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR <25% is
associated with survival between 11-24%.
The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore
adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal
egress of lung fluid during pulmonary development leading to increased lung tissue stretch,
increased cell proliferation, and accelerated lung growth. European colleagues have developed
intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal tracheal
balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium group
published summary results of FETO showing an improved survival in 175 patients with isolated
left CDH from 24% to 49%. Our goal with this pilot study is to study the feasibility of
implementing FETO therapy in the most severe group of fetuses with left CDH (O/E LHR < 30%).
which will be considered in two subgroups. Those with and O/E LHR <25% (severe group) and
those with an O/E between 25 to <30% (less severe group).
membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that
minimize ventilator-induced lung injury, morbidity and mortality rates for babies with
congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of
prenatal lung compression and the subsequent impairment of pulmonary function following
delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate
the severity by relating the circumference of the lung contralateral to the hernia to the
fetal head circumference lung to head ratio (LHR) and by noting the degree of upward
herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR),
prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While
overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR <25% is
associated with survival between 11-24%.
The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore
adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal
egress of lung fluid during pulmonary development leading to increased lung tissue stretch,
increased cell proliferation, and accelerated lung growth. European colleagues have developed
intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal tracheal
balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium group
published summary results of FETO showing an improved survival in 175 patients with isolated
left CDH from 24% to 49%. Our goal with this pilot study is to study the feasibility of
implementing FETO therapy in the most severe group of fetuses with left CDH (O/E LHR < 30%).
which will be considered in two subgroups. Those with and O/E LHR <25% (severe group) and
those with an O/E between 25 to <30% (less severe group).
Study Procedures The FETO feasibility study is an un-blinded non-randomized single arm pilot
study being conducted at the Johns Hopkins Hospital.
Pregnant women will be screened for protocol inclusion and exclusion criteria and recruited.
Comprehensive fetal evaluations will be completed at the Johns Hopkins Center for Fetal
Therapy to confirm eligibility. This includes an ultrasound, magnetic resonance imaging, a
fetal echocardiogram and fetal genetic studies to identify cases with isolated CDH. Once
eligibility is confirmed, participation for FETO treatment will be offered. The voluntary
nature of participation will be stressed throughout. Willingness and logistics of the
participant to remain under supervision of the Center for Fetal Therapy at the Johns Hopkins
Hospital, while the fetal airway is occluded will also be discussed in detail. Informed
written consent will be obtained prior to any study related procedures.
Study design Participants will undergo FETO with standardized preoperative, intraoperative,
post-operative care, and delivery. The FETO will be timed between 27+0 to 29+6 weeks
gestation for fetuses with an O/E LHR <25% and between 30+0 to 31+6 weeks gestation for
fetuses with an O/E LHR between 25% to <30%. The procedure will be performed under local
anesthesia with IV sedation or regional spinal/epidural (as done currently for shunts and
laser procedures). Prophylactic tocolysis using indomethacin will begin preoperatively. Fetal
analgesia and immobilization will consist of fentanyl, atropine and vecuronium. A 10 Fr
cannula, 1.3 mm fetoscope within a 3.3 mm sheath (Karl Storz, Tuttlingen, Germany), and a
detachable balloon occlusion (BALTACCI-BDPE, Balt, Montmorency, France) system will be used.
Participants will receive IV magnesium sulfate for breakthrough labor and may be discharged
on oral nifedipine to treat post intervention contractions. Serial ultrasound measurements of
lung volume and LHR will begin within 24-48 hours following surgery and continue weekly.
Amniotic fluid level and membrane status will also be monitored at weekly intervals.
Ultrasonography for fetal growth will be performed every 4 weeks.
All discharged participants and their support person need to remain within 30 minutes of the
surgery center until delivery to permit standardized postoperative management. The social
worker at the Center for Fetal Therapy will serve as the participant advocate and assist
families in identifying subsidized appropriate accommodation as required. Participants will
be on modified bed rest for the first 2 weeks post discharge, but subsequently allowed to
graduate to moderate activity if the uterus is quiescent. Postoperative surveillance of fetal
well-being will be performed weekly beginning at 28 weeks.
At 34+0 weeks to 34 + 6 weeks, participants will undergo removal of the tracheal balloon.
Balloon retrieval can be either by in utero puncture by ultrasound-guided percutaneous
needling or fetoscopic retrieval. Uncomplicated retrieval patients will be managed as an
outpatient with weekly fetal monitoring until delivery. In the event there is a need for
emergent balloon removal prior to 34 weeks due to the development of preterm labor,
shortening of the cervix, preterm rupture of membranes, abnormally vigorous lung response, or
development of fetal hydrops, delivery by EXIT or cesarean section will be performed. If
percutaneous puncture of balloon is unsuccessful prior to delivery, immediate bronchoscopy
and establishment of airway will be performed. Maternal corticosteroids (betamethasone 12 mg
intramuscularly and repeated once at 24 hours) will be administered 48 hours prior to
fetoscopic balloon removal (due to risks of preterm delivery associated with instrumentation)
or for impending preterm delivery.
Timing for induction of labor at 37 weeks to 39 weeks will depend upon favorable status of
the cervix. Cesarean section will be based upon standard obstetrical indications. In regards
to postnatal care, a resuscitation team from neonatology and pediatric surgery will be
present at delivery. A standardized protocol will be utilized for postnatal care, using lung
protection strategy.
While the primary end-points of the study are the demonstration of the feasibility and safety
of FETO and neonatal survival at discharge continued follow-up of children until age 2 is
planned as the current standard of care. These follow-ups may include bronchoscopy, brain
imaging, audiology exam, pulmonary function testing, chest radiograph and developmental
assessment.
Study duration and number of visits The feasibility study will be conducted at Johns Hopkins
Hospital. Recruitment will stop when approximately 10 to 15 families (mother, father/partner
and child) will be enrolled to produce 5 to 10 families available for evaluation. The study
duration per mother and child will be up to 877 days, with up to 82 days screening, up to 55
days in the intervention phase, and 744 days in delivery and follow-up.
The following details the standard of care and research procedures at each phase of the
study.
Screening Visit Potential subjects (pregnant women) will be screened for protocol inclusion
and exclusion criteria.
Standard of Care Procedures
- Comprehensive obstetrical ultrasound exam, including documentation of cervical length,
GA, biometry, liver herniation, hepatic vasculature, sonographic lung volume, amniotic
fluid level, membrane status, and LHR calculation
- Fetal echocardiogram to rule out structural abnormalities
- Maternal MRI to confirm fetal liver herniation as required
- Demographics/medical history
- Physical exam including vital signs and maternal height and weight
- Laboratory tests including karyotyping and comparative genome hybridization to asses for
fetal genetic syndromes
- Social evaluation to identify family support and possible confounding social issues
- Patient education including: CDH description, prenatal and neonatal development, general
expected outcomes and management options Once evaluation confirms eligibility, the
family will be offered enrollment. Informed consent will be obtained prior to any study
related procedures Research Procedures No study procedures will be performed prior to
obtaining voluntary informed consent. The social worker designated for the Center for
Fetal Therapy has experience in accompanying the care of patients with a wide range of
fetal anomalies. The social worker will serve as the patient advocate in this study.
- Informed consent
- Description of study rationale and design
- Focused interview by the PI or designee to afford potential pregnant women the formal
opportunity to examine what they have learned about the research study in the course of
their evaluation and discuss how they feel about enrolling in the research study
- Review of inclusion/exclusion criteria
- Clearance for surgery by anesthesia and the obstetrical staff
Study Procedures (following the screening visit) The study procedure phase includes FETO
surgery, and removal of the balloon. FETO Surgery (all procedures are part of this research
study)
- Participants with an O/E LHR 25% will have FETO completed at 27 weeks + 0 days to 29
weeks + 6 days gestation.
- Participants with an O/E LHR 25 - <30% will have FETO completed at 30 weeks + 0 days to
31 weeks + 6 days gestation.
The procedure will be completed under ultrasound guidance along with maternal IV sedation,
local anesthesia, and prophylactic tocolysis using indomethacin for 48 hours. Fetal analgesia
and immobilization will consist of fentanyl, atropine and vecuronium.
- A 10 Fr cannula, 1.2 mm fetoscope within a 3.0 mm sheath (Karl Storz, Tuttlingen,
Germany), and a detachable balloon occlusion (BALTACCI-BDPE, Balt, Montmorency, France)
system will be used.
- The expected hospital course is 23-48 hours; however, it is possible that the patient
will be hospitalized for complications or preterm labor. The patient will then be
discharged to a nearby accommodation.
- Assess possible adverse events
- Physical exam of the mother including weight, vital signs
- Laboratory tests
- Preparation for surgery
- Transvaginal ultrasound (within 24 hours of FETO balloon insertion procedure) It is
standard of care to have all patients receiving fetal therapy that require delivery at
Johns Hopkins Hospital transfer prenatal care to the Center for Fetal Therapy. For this
study, pregnant woman will transfer care prior to the FETO procedure and social work
will facilitate relocation to a radius of 30 minutes from Johns Hopkins Hospital while
the balloon is in place and the fetus has an occluded airway. Pregnant women are
expected to have a support person with them and will be instructed to travel by car or
taxi directly to Johns Hopkins Hospital in the event of onset of labor or suspected
preterm rupture of membranes.
Weekly Check-ups (Balloon insertion to delivery)
Standard of Care Procedures
- Medical record review
- Fetal surveillance by Doppler studies, assessment of amniotic fluid, growth and LHR
measurement, and fetal echocardiography
- Physical exam, weight, vital signs, maternal urinalysis for proteinuria
- Biophysical profiles (weekly beginning at 28 weeks GA)
- Maternal MRI (targeted MRI to assess the progress and growth of lung tissue prior to
balloon removal)
Research Procedures (only performed while the balloon is in place)
- Assess possible adverse events (performed at all weekly check-ups)
- Medical record review
Removal of Balloon (all procedures are part of this research study)
- Removal of the balloon occlusion will be performed at 34 weeks 0 days to 34 weeks 6
days.
- Physical exam, weight, vital signs
- Laboratory tests
- Assess possible adverse events
- Preparation for surgery
- Clearance for surgery by anesthesia and the obstetrical staff. Anesthesia regional
(spinal or epidural) in preparation for possible emergent delivery.
- Maternal corticosteroids will be administered 48 hours prior to removal of balloon
occlusion
- Tocolysis nifedipine 20 mg preoperatively and then every 6 hours for 48 hours.
Breakthrough contractions treated with increased dose of nifedipine or Magnesium
sulfate.
- Procedure - attempted percutaneous needle puncture followed by fetoscopic removal of
balloon only if this is unsuccessful.
Delivery Planned delivery will occur after 37 weeks. Timing for induction of labor at 37
weeks 0 days to 39 weeks 0 days will depend upon favorable status of the cervix. Cesarean
section will be based upon standard obstetrical indications.
Standard of Care Procedures:
- For preterm labor before the balloon has been removed, pregnant woman will be admitted
for tocolysis and attempt to prolong pregnancy.
- For preterm labor that cannot be controlled before balloon removal, delivery by Ex Utero
Intrapartum Therapy (EXIT), if maternally safe, may be performed. Emergent EXIT
algorithms are in place and are currently used for fetuses with obstructed airways.
These algorithms will be activated for mothers presenting in labor prior to plan EXIT
delivery at Johns Hopkins Hospital.
- For precipitous preterm labor or maternal indications when EXIT cannot be performed,
cesarean delivery may be performed followed by immediate bronchoscopy and establishment
of airway.
- Delivery
- Standard postnatal care Research Procedures
- Assess possible adverse events relating to FETO Follow-up Phase Follow-up will be
conducted from birth to 24 months of age at which time the study will conclude. Consent
to obtain information about the clinical course after the neonatal period will be
obtained after birth.
A resuscitation team from neonatology and pediatric surgery will be present at delivery. A
standardized protocol will be utilized for postnatal care. Follow-up will may include
bronchoscopy, brain imaging, audiology exams, pulmonary function testing, chest radiographs,
and developmental assessment per the current standard of care for infants with CDH at Johns
Hopkins Hospital.
study being conducted at the Johns Hopkins Hospital.
Pregnant women will be screened for protocol inclusion and exclusion criteria and recruited.
Comprehensive fetal evaluations will be completed at the Johns Hopkins Center for Fetal
Therapy to confirm eligibility. This includes an ultrasound, magnetic resonance imaging, a
fetal echocardiogram and fetal genetic studies to identify cases with isolated CDH. Once
eligibility is confirmed, participation for FETO treatment will be offered. The voluntary
nature of participation will be stressed throughout. Willingness and logistics of the
participant to remain under supervision of the Center for Fetal Therapy at the Johns Hopkins
Hospital, while the fetal airway is occluded will also be discussed in detail. Informed
written consent will be obtained prior to any study related procedures.
Study design Participants will undergo FETO with standardized preoperative, intraoperative,
post-operative care, and delivery. The FETO will be timed between 27+0 to 29+6 weeks
gestation for fetuses with an O/E LHR <25% and between 30+0 to 31+6 weeks gestation for
fetuses with an O/E LHR between 25% to <30%. The procedure will be performed under local
anesthesia with IV sedation or regional spinal/epidural (as done currently for shunts and
laser procedures). Prophylactic tocolysis using indomethacin will begin preoperatively. Fetal
analgesia and immobilization will consist of fentanyl, atropine and vecuronium. A 10 Fr
cannula, 1.3 mm fetoscope within a 3.3 mm sheath (Karl Storz, Tuttlingen, Germany), and a
detachable balloon occlusion (BALTACCI-BDPE, Balt, Montmorency, France) system will be used.
Participants will receive IV magnesium sulfate for breakthrough labor and may be discharged
on oral nifedipine to treat post intervention contractions. Serial ultrasound measurements of
lung volume and LHR will begin within 24-48 hours following surgery and continue weekly.
Amniotic fluid level and membrane status will also be monitored at weekly intervals.
Ultrasonography for fetal growth will be performed every 4 weeks.
All discharged participants and their support person need to remain within 30 minutes of the
surgery center until delivery to permit standardized postoperative management. The social
worker at the Center for Fetal Therapy will serve as the participant advocate and assist
families in identifying subsidized appropriate accommodation as required. Participants will
be on modified bed rest for the first 2 weeks post discharge, but subsequently allowed to
graduate to moderate activity if the uterus is quiescent. Postoperative surveillance of fetal
well-being will be performed weekly beginning at 28 weeks.
At 34+0 weeks to 34 + 6 weeks, participants will undergo removal of the tracheal balloon.
Balloon retrieval can be either by in utero puncture by ultrasound-guided percutaneous
needling or fetoscopic retrieval. Uncomplicated retrieval patients will be managed as an
outpatient with weekly fetal monitoring until delivery. In the event there is a need for
emergent balloon removal prior to 34 weeks due to the development of preterm labor,
shortening of the cervix, preterm rupture of membranes, abnormally vigorous lung response, or
development of fetal hydrops, delivery by EXIT or cesarean section will be performed. If
percutaneous puncture of balloon is unsuccessful prior to delivery, immediate bronchoscopy
and establishment of airway will be performed. Maternal corticosteroids (betamethasone 12 mg
intramuscularly and repeated once at 24 hours) will be administered 48 hours prior to
fetoscopic balloon removal (due to risks of preterm delivery associated with instrumentation)
or for impending preterm delivery.
Timing for induction of labor at 37 weeks to 39 weeks will depend upon favorable status of
the cervix. Cesarean section will be based upon standard obstetrical indications. In regards
to postnatal care, a resuscitation team from neonatology and pediatric surgery will be
present at delivery. A standardized protocol will be utilized for postnatal care, using lung
protection strategy.
While the primary end-points of the study are the demonstration of the feasibility and safety
of FETO and neonatal survival at discharge continued follow-up of children until age 2 is
planned as the current standard of care. These follow-ups may include bronchoscopy, brain
imaging, audiology exam, pulmonary function testing, chest radiograph and developmental
assessment.
Study duration and number of visits The feasibility study will be conducted at Johns Hopkins
Hospital. Recruitment will stop when approximately 10 to 15 families (mother, father/partner
and child) will be enrolled to produce 5 to 10 families available for evaluation. The study
duration per mother and child will be up to 877 days, with up to 82 days screening, up to 55
days in the intervention phase, and 744 days in delivery and follow-up.
The following details the standard of care and research procedures at each phase of the
study.
Screening Visit Potential subjects (pregnant women) will be screened for protocol inclusion
and exclusion criteria.
Standard of Care Procedures
- Comprehensive obstetrical ultrasound exam, including documentation of cervical length,
GA, biometry, liver herniation, hepatic vasculature, sonographic lung volume, amniotic
fluid level, membrane status, and LHR calculation
- Fetal echocardiogram to rule out structural abnormalities
- Maternal MRI to confirm fetal liver herniation as required
- Demographics/medical history
- Physical exam including vital signs and maternal height and weight
- Laboratory tests including karyotyping and comparative genome hybridization to asses for
fetal genetic syndromes
- Social evaluation to identify family support and possible confounding social issues
- Patient education including: CDH description, prenatal and neonatal development, general
expected outcomes and management options Once evaluation confirms eligibility, the
family will be offered enrollment. Informed consent will be obtained prior to any study
related procedures Research Procedures No study procedures will be performed prior to
obtaining voluntary informed consent. The social worker designated for the Center for
Fetal Therapy has experience in accompanying the care of patients with a wide range of
fetal anomalies. The social worker will serve as the patient advocate in this study.
- Informed consent
- Description of study rationale and design
- Focused interview by the PI or designee to afford potential pregnant women the formal
opportunity to examine what they have learned about the research study in the course of
their evaluation and discuss how they feel about enrolling in the research study
- Review of inclusion/exclusion criteria
- Clearance for surgery by anesthesia and the obstetrical staff
Study Procedures (following the screening visit) The study procedure phase includes FETO
surgery, and removal of the balloon. FETO Surgery (all procedures are part of this research
study)
- Participants with an O/E LHR 25% will have FETO completed at 27 weeks + 0 days to 29
weeks + 6 days gestation.
- Participants with an O/E LHR 25 - <30% will have FETO completed at 30 weeks + 0 days to
31 weeks + 6 days gestation.
The procedure will be completed under ultrasound guidance along with maternal IV sedation,
local anesthesia, and prophylactic tocolysis using indomethacin for 48 hours. Fetal analgesia
and immobilization will consist of fentanyl, atropine and vecuronium.
- A 10 Fr cannula, 1.2 mm fetoscope within a 3.0 mm sheath (Karl Storz, Tuttlingen,
Germany), and a detachable balloon occlusion (BALTACCI-BDPE, Balt, Montmorency, France)
system will be used.
- The expected hospital course is 23-48 hours; however, it is possible that the patient
will be hospitalized for complications or preterm labor. The patient will then be
discharged to a nearby accommodation.
- Assess possible adverse events
- Physical exam of the mother including weight, vital signs
- Laboratory tests
- Preparation for surgery
- Transvaginal ultrasound (within 24 hours of FETO balloon insertion procedure) It is
standard of care to have all patients receiving fetal therapy that require delivery at
Johns Hopkins Hospital transfer prenatal care to the Center for Fetal Therapy. For this
study, pregnant woman will transfer care prior to the FETO procedure and social work
will facilitate relocation to a radius of 30 minutes from Johns Hopkins Hospital while
the balloon is in place and the fetus has an occluded airway. Pregnant women are
expected to have a support person with them and will be instructed to travel by car or
taxi directly to Johns Hopkins Hospital in the event of onset of labor or suspected
preterm rupture of membranes.
Weekly Check-ups (Balloon insertion to delivery)
Standard of Care Procedures
- Medical record review
- Fetal surveillance by Doppler studies, assessment of amniotic fluid, growth and LHR
measurement, and fetal echocardiography
- Physical exam, weight, vital signs, maternal urinalysis for proteinuria
- Biophysical profiles (weekly beginning at 28 weeks GA)
- Maternal MRI (targeted MRI to assess the progress and growth of lung tissue prior to
balloon removal)
Research Procedures (only performed while the balloon is in place)
- Assess possible adverse events (performed at all weekly check-ups)
- Medical record review
Removal of Balloon (all procedures are part of this research study)
- Removal of the balloon occlusion will be performed at 34 weeks 0 days to 34 weeks 6
days.
- Physical exam, weight, vital signs
- Laboratory tests
- Assess possible adverse events
- Preparation for surgery
- Clearance for surgery by anesthesia and the obstetrical staff. Anesthesia regional
(spinal or epidural) in preparation for possible emergent delivery.
- Maternal corticosteroids will be administered 48 hours prior to removal of balloon
occlusion
- Tocolysis nifedipine 20 mg preoperatively and then every 6 hours for 48 hours.
Breakthrough contractions treated with increased dose of nifedipine or Magnesium
sulfate.
- Procedure - attempted percutaneous needle puncture followed by fetoscopic removal of
balloon only if this is unsuccessful.
Delivery Planned delivery will occur after 37 weeks. Timing for induction of labor at 37
weeks 0 days to 39 weeks 0 days will depend upon favorable status of the cervix. Cesarean
section will be based upon standard obstetrical indications.
Standard of Care Procedures:
- For preterm labor before the balloon has been removed, pregnant woman will be admitted
for tocolysis and attempt to prolong pregnancy.
- For preterm labor that cannot be controlled before balloon removal, delivery by Ex Utero
Intrapartum Therapy (EXIT), if maternally safe, may be performed. Emergent EXIT
algorithms are in place and are currently used for fetuses with obstructed airways.
These algorithms will be activated for mothers presenting in labor prior to plan EXIT
delivery at Johns Hopkins Hospital.
- For precipitous preterm labor or maternal indications when EXIT cannot be performed,
cesarean delivery may be performed followed by immediate bronchoscopy and establishment
of airway.
- Delivery
- Standard postnatal care Research Procedures
- Assess possible adverse events relating to FETO Follow-up Phase Follow-up will be
conducted from birth to 24 months of age at which time the study will conclude. Consent
to obtain information about the clinical course after the neonatal period will be
obtained after birth.
A resuscitation team from neonatology and pediatric surgery will be present at delivery. A
standardized protocol will be utilized for postnatal care. Follow-up will may include
bronchoscopy, brain imaging, audiology exams, pulmonary function testing, chest radiographs,
and developmental assessment per the current standard of care for infants with CDH at Johns
Hopkins Hospital.
Inclusion Criteria:
- Pregnant women age 18 years and older, who are able to consent.
- Singleton pregnancy.
- Anatomically and chromosomally normal fetus.
- Left sided diaphragmatic hernia with liver up.
- Gestation at enrollment prior to 27+0 to 29+6 weeks in patients with O/E LHR of 25% or
30+0 to 31+6 weeks in patients with O/E 25 -<30%.
- SEVERE pulmonary hypoplasia with O/E LHR < 30%.
Exclusion Criteria:
- Pregnant women < 18 years.
- Women with allergy to Latex.
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition
in pregnancy.
- Technical limitations precluding fetoscopic surgery.
- History of natural rubber latex allergy.
- Preterm labor, cervix shortened <15 mm within 24 hours prior to the FETO balloon
insertion or uterine anomaly strongly predisposing to preterm labor, placenta previa.
- Psychosocial ineligibility, precluding consent.
- Maternal depression as assessed by a Beck Depression Inventory score equal to or
greater than 17.
- Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated
left-sided with the O/E LHR ≥ 30%.
- Inability to remain close to the FETO site during time period of tracheal occlusion.
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