Clinical Trials Logo

Clinical Trial Summary

This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO) rather than expectant management during pregnancy, followed by standardized postnatal management, increases survival at discharge and decreases oxygen need at 6 months in case of survival till discharge.


Clinical Trial Description

This is a multi-center, non-blinded randomized controlled trial in fetuses with isolated moderate CDH, i.e. moderate lung hypoplasia (as determined by prenatal assessment of lung development). It essentially compares fetal therapy added to conventional postnatal care, versus expectant prenatal management during pregnancy followed by conventional postnatal care. Enrollment: Following completion of an inclusion/exclusion criteria checklist and obtaining informed consent, the subject will be randomized into two groups ("FETO" and "expectant"). Procedures: Group I: Standardized postnatal care (expectant group): mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. Group II: Prenatal intervention (FETO group): patients will undergo fetoscopic tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in I. In this study FETO is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days. This study trial is a pragmatical or efficacy trial: ideally mothers will deliver after removal of the balloon at those tertiary centers, typically offering postnatal care for the patient involved. In group II (FETO-group), mothers will, in between placement and removal of the balloon, thus carrying a fetus with obstructed airways, ideally remain under the care of our local fetal treatment center (further referred to as FETO center). As many as possible precautions are taken to avoid problems with balloon removal in case of earlier than expected delivery. - Balloons are to be electively removed prior to 35 weeks. FETO centers will provide 24/24 hours and 7/7 days services for management of fetuses with obstructed airways, either in utero or during labor and delivery. - Patients in the study and randomized to FETO, will be encouraged to stay near the FETO center. After reversal of the occlusion the patient will be referred to the tertiary care center where delivery and postnatal care will be undertaken. If the patient is not remaining at or close to the FETO center, the postnatal treatment center should organize likewise EXIT services. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02875860
Study type Interventional
Source Baylor College of Medicine
Contact
Status Completed
Phase Phase 2
Start date January 2017
Completion date October 2019

See also
  Status Clinical Trial Phase
Completed NCT01629485 - Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair N/A
Completed NCT01205399 - A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft N/A
Terminated NCT01305486 - A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation N/A
Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
Completed NCT00905320 - Hernia Repair With or Without Sutures N/A
Completed NCT00617357 - Repair of Infected or Contaminated Hernias N/A
Completed NCT00535990 - Minimally Invasive Surgery (MIS) Database for the Purpose of Research
Withdrawn NCT00138957 - Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh N/A
Completed NCT06034652 - T-GENVIH-003 LTFU (Long Term Follow Up) Study
Completed NCT06389331 - Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia
Completed NCT04119466 - Stabilizing Training in Degenerative Disc Disease N/A
Completed NCT00622583 - International Hernia Mesh Registry
Completed NCT04137172 - Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia. N/A
Completed NCT01132209 - Suture Techniques to Reduce the Incidence of The inCisional Hernia N/A
Completed NCT00032448 - Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients? Phase 3
Not yet recruiting NCT05061589 - Incidence and Risk Factors of Parastomal Hernia in Patients With Permanent Colostomy in China
Active, not recruiting NCT02439060 - PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit) N/A
Completed NCT01727388 - Informativeness to Digital Rectal Examination Phase 3
Completed NCT02238964 - Reinforcement of Closure of Stoma Site Phase 2/Phase 3
Completed NCT01997619 - Biological Mesh Repair of Complex Hernias in High Risk Patients N/A