North American Fetal Therapy Network for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \< 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \< 30% that receive FETO procedure performed at 27 weeks 0 days to 29weeks 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH \< 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR \< 45% that undergo FETO procedure performed at 27 weeks 0 days to 29 weeks 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR \< 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o/e LHR \<30% when compared to isolated LCDH with o/e LRH \<30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o/e LHR ≤ 45% when compared to isolated RCHD with LHR \< 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant women who are able to consent

Singleton pregnancy

Normal Karyotype, chromosomal microanalysis (CMA) with non-pathologic variants, Whole exome sequencing (WES) or whole genome sequencing (WGS) . Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks

Gestational age at enrollment is prior to 296 wks.

Disqualifiers

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, placenta previa.

Inability to reside within 30 minutes of University of Texas Health Science Center at Houston Fetal Center

The 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 UTHealth Houston Fetal Center

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fetal Treatment arm (FETO Group)

    Device

    Participants will undergo FETO surgery at at 27 weeks 0 days - 29 weeks 6 days gestation.Balloon insertion into the fetal trachea will be performed. This will be followed by weekly \\ ultrasound monitoring and MRI at 3 weeks following FETO insertion and removal of the balloon which will be performed at at 34 weeks 0 days to 34 weeks 6 days. Planned delivery will occur after 37 weeks. The follow-up phase will be conducted from birth to 24 months of age

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Fetal Treatment arm (FETO Group)Experimental treatment 1 intervention
Group B: Expectant Management Arm (Control Group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of neonates that survived

Time frame
from delivery to hospital discharge (up to 12 months)
2

Number of Successful placement of FETO device

Time frame
10-60 minutes after surgery begins
3

Number of Successful removal of FETO device

Time frame
immediately after the procedure (about 1 hour after start of surgery)
4

FETO procedure complications

Complications include, Failure FETO insertion procedure, FETO device dislodgement potentially requiring a second FETO insertion, Fetal intraoperative injury, Procedural hemorrhage, Bleeding from insertion site or Abruptions, Post-procedural hemorrhage PPROM, Preterm delivery, Chorioamnion separation,Chorioamnionitis, Polyhydramnios, Oligohydramnios,Emergent removal due to obstetrical complication, Failed percutaneous or fetoscopic removal requiring cesarean section or exit procedure for removal, Neonatal death due to asphyxia if delivery before FETO removal and Non-reassuring fetal heart rate monitoring

Time frame
end of study (24 months)

Secondary outcomes

1

Number of infants that survived

Time frame
6 months
2

Number of infants that survived

Time frame
12 months
3

Number of infants that survived

Time frame
18 months
4

Number of infants that survived

Time frame
24 months

Other outcomes

Sponsors and contacts

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