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RecruitingNCT06739356Updated Aug 19, 2025

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

An interventional study of Fetal Treatment arm (FETO Group) in Congenital Diaphragmatic Hernia, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-19.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Congenital Diaphragmatic Hernia

Keywords

  • Fetoscopic Endoluminal Tracheal Occlusion
03

In context

Hernias, Diaphragmatic, Congenital

93 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.

This study's planned enrollment of 80 is above the median of 28 across 64 interventional studies indexed under Hernias, Diaphragmatic, Congenital.

Browse Hernias, Diaphragmatic, Congenital studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • Intrathoracic liver herniation
  • Isolated left CDH with o/e LHR \< 30% at enrollment (180 to 295 wks.). or
  • Isolated RCDH with o/e LHR \< 45% at enrollment (180 to 295 wks.)
  • Cervical length by transvaginal ultrasound > 20 mm within 24 hours prior to FETO procedure
  • Patient meets psychosocial criteria
  • Informed consent understood

Exclusion criteria

Exclusion Criteria:

  • 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.

  • Psychosocial ineligibility, precluding consent:

    1. Inability to reside within 30 minutes of University of Texas Health Science Center at Houston Fetal Center
    2. 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
  • Bilateral CDH, isolated left sided CDH with O/E LHR ≥ 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR > 45% (measured at 180 to 295 weeks), as determined by ultrasound
  • No liver herniation into thoracic cavity
  • Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., CDH and congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns).
  • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  • 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 because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
  • Uterine anomalies such as large or multiple fibroids or Mullerian duct abnormality
  • There is 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Fetal Treatment arm (FETO Group)

    Device: Fetal Treatment arm (FETO Group)

  • No intervention
    Expectant Management Arm (Control Group)

Interventions

  • DeviceFetal Treatment arm (FETO Group)

    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

06

What researchers measure

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

  5. Number of infants that show presence of pulmonary hypertension

    Time frame: 6 months

  6. Number of infants that show presence of pulmonary hypertension

    Time frame: 12 months

  7. Number of infants that show presence of pulmonary hypertension

    Time frame: 18 months

  8. Number of infants that show presence of pulmonary hypertension

    Time frame: 24 months

  9. Number of infants that show need for supplemental oxygen

    Time frame: 6 months

  10. Number of infants that show need for supplemental oxygen

    Time frame: 12 months

  11. Number of infants that show need for supplemental oxygen

    Time frame: 18 months

  12. Number of infants that show need for supplemental oxygen

    Time frame: 24 months

  13. Number of infants that show periventricular leukomalacia

    Time frame: at less than 2 months postnatally

  14. Number of Infants that develop sepsis

    Time frame: 6 months

  15. Number of Infants that develop sepsis

    Time frame: 12 months

  16. Number of Infants that develop sepsis

    Time frame: 18 months

  17. Number of Infants that develop sepsis

    Time frame: 24 months

  18. Number of infants that develop Intraventricular hemorrhage (grade 0-III)

    Time frame: 6 months

  19. Number of infants that develop Intraventricular hemorrhage (grade 0-III)

    Time frame: 12 months

  20. Number of infants that develop Intraventricular hemorrhage (grade 0-III)

    Time frame: 18 months

  21. Number of infants that develop Intraventricular hemorrhage (grade 0-III)

    Time frame: 24 months

  22. Number of infants that develop retinopathy of prematurity (grade 3 or higher)

    Time frame: 6 months

  23. Number of infants that develop retinopathy of prematurity (grade 3 or higher)

    Time frame: 12 months

  24. Number of infants that develop retinopathy of prematurity (grade 3 or higher)

    Time frame: 18 months

  25. Number of infants that develop retinopathy of prematurity (grade 3 or higher)

    Time frame: 24 months

  26. Number of infants that develop gastro-esophageal reflux

    Time frame: 6 months

  27. Number of infants that develop gastro-esophageal reflux

    Time frame: 12 months

  28. Number of infants that develop gastro-esophageal reflux

    Time frame: 18 months

  29. Number of infants that develop gastro-esophageal reflux

    Time frame: 24 months

  30. Number of infant hospital readmissions

    Time frame: end of study (24 months)

  31. Cause of infant hospital readmissions

    Time frame: end of study (24 months)

  32. Number of infants that show childhood growth failure

    Time frame: 6 months

  33. Number of infants that show childhood growth failure

    Time frame: 12 months

  34. Number of infants that show childhood growth failure

    Time frame: 18 months

  35. Number of infants that show childhood growth failure

    Time frame: 24 months

  36. Number of infants that show recurrence of CDH repair

    Time frame: 6 months

  37. Number of infants that show recurrence of CDH repair

    Time frame: 12 months

  38. Number of infants that show recurrence of CDH repair

    Time frame: 18 months

  39. Number of infants that show recurrence of CDH repair

    Time frame: 24 months

  40. Number of infants that develop bowel obstruction

    Time frame: 6 months

  41. Number of infants that develop bowel obstruction

    Time frame: 12 months

  42. Number of infants that develop bowel obstruction

    Time frame: 18 months

  43. Number of infants that develop bowel obstruction

    Time frame: 24 months

  44. Number of infants that show neurodevelopmental delay as assessed by the Bayley Scales of Infant and Toddler Development-III(BSID)

    Three domains will be measured as follows: Cognitive Scale, Language Scale (Receptive and Expressive) and Motor Scale (Fine and Gross Motor Skills). Scores are derived by converting raw scores from completed tasks into scale scores and composite scores. These scores are then utilized to assess the child's performance in relation to norms established based on typically developing children of the same age Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning. Scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment. In general, scores falling in the lowest 10th percentile indicate developmental delay

    Time frame: 24 months

  45. Number of infants that develop bronchopulmonary dysplasia

    Time frame: 6 months

  46. Number of infants that develop bronchopulmonary dysplasia

    Time frame: 12 months

  47. Number of infants that develop bronchopulmonary dysplasia

    Time frame: 18 months

  48. Number of infants that develop bronchopulmonary dysplasia

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06739356
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Anthony Johnson (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Dec 18, 2024
Start date
Mar 4, 2025
Primary completion
Dec 1, 2029 (estimated)
Completion
Dec 1, 2031 (estimated)
Last update
Aug 19, 2025

Study contacts

Anthony Johnson, DO
Contact
Anthony.Johnson@uth.tmc.edu
(713) 500-5859
Elisa Garcia
Contact
Elisa.I.Garcia@uth.tmc.edu
(713) 500-7434
Anthony Johnson, DO
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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