Clinical trials: Hernia, DIaphragmatic, Congenital
Congenital Diaphragmatic Hernia
Early FETO for Severe Congenital Diaphragmatic Hernia
Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in those cases with severe forms where there are extremely reduced lung volumes, liver herniation and decreased abnormal pulmonary…
- Trial name
- NCT01731509
- Testing
- Fetal endoscopic tracheal occlusion
- Where
- Brazil
- Volunteers
- 70 people
- Sponsor
- University of Sao Paulo General Hospital
Congenital Diaphragmatic Hernia, Congenital Abnormality
Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial
The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is higher than 90% due to severe pulmonary hypoplasia.
- Trial name
- BRAFETO (NCT01302977)
- Testing
- Fetal tracheal occlusion
- Where
- Brazil
- Volunteers
- 36 people
- Sponsor
- University of Sao Paulo General Hospital
Congenital Diaphragmatic Hernia
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left 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…
- Trial name
- FETO (NCT02710968)
- Testing
- 11540KE and Balt Goldbal 2 balloon
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Johns Hopkins University
Congenital Diaphragmatic Hernia
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
The purpose of this study is to determine if de-implementation of inhaled nitric oxide (iNO) in the post-natal resuscitation/stabilization phase affects the composite outcome of extracorporeal life support (ECLS) use and/or…
- Trial name
- NCT05213676
- Testing
- Inhaled Nitric Oxide (iNO) use, De-implementation of Inhaled Nitric Oxide (iNO) use
- Where
- 19 sites in United States
- Volunteers
- 900 people
- Sponsor
- The University of Texas Health Science Center, Houston
Congenital Diaphragmatic Hernia, Pulmonary Hypertension
Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia
This multicenter, prospective, single-arm study aims to evaluate the efficacy of inhaled nitric oxide (iNO) in neonates with congenital diaphragmatic hernia (CDH) and early pulmonary hypertension.
- Trial name
- INOCDH (NCT07247240)
- Testing
- Inhaled Nitric Oxide
- Where
- 4 sites in South Korea
- Volunteers
- 40 people
- Sponsor
- Asan Medical Center
Hernia, Hernia, Diaphragmatic
'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial
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…
- Conditions
- Hernia, Hernia, Diaphragmatic, Hernia, DIaphragmatic, Congenital, Pathological Conditions, Anatomical
- Trial name
- TOTAL (NCT02875860)
- Testing
- GoldBal2 detachable balloon, Baltaccidbpe100 Delivery Catheter, Standardized postnatal care
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Michael A Belfort
Congenital Diaphragmatic Hernia
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe…
- Trial name
- NCT07564297
- Testing
- Fetoscopic Endoluminal Tracheal Occlusion, Standard of Care
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Mayo Clinic
Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn
Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates
The aim of the study 1. To evaluate safety and efficacy of melatonin as an adjuvant therapy to inhaled nitric oxide generated by NO generator in the treatment of pulmonary hypertension in full term neonates. 2.
- Conditions
- Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn, Congenital Diaphragmatic Hernia
- Trial name
- NCT07850934
- Testing
- Melatonin, nitric oxide generator
- Where
- Egypt
- Volunteers
- 52 people
- Sponsor
- Ain Shams University
Congenital Diaphragmatic Hernia
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter…
- Trial name
- FETO (NCT05421676)
- Testing
- FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, Davis
Congenital Diaphragmatic Hernia
CDH - Optimisation of Neonatal Ventilation
To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia.
- Trial name
- CDH-ONV (NCT02849054)
- Testing
- Measurement of PTPdi, TTV at 4ml/kg, TTV at 5ml/kg
- Where
- United Kingdom
- Volunteers
- 18 people
- Sponsor
- King's College London
Diaphragmatic Hernia
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University…
- Trial name
- NCT05354505
- Testing
- Placement of the GOLDBAL2 balloon
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Vincent Duron
Severe Congenital Diaphragmatic Hernia
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe CDH
The purpose of this pilot study is to evaluate the feasibility of using Fetoscopic Endoluminal Tracheal Occlusion (FETO) in 10 pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia (CDH).
- Trial name
- NCT07767825
- Testing
- Goldballoon Detachable Balloon (GOLDBAL2)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- NYU Langone Health
Congenital Diaphragmatic Hernia
Management of Late Presenting Congenital Diaphragmatic Hernia .
Diagnosis and different ways of surgical repair of Congenital diaphragmatic hernia
- Trial name
- NCT07397793
- Testing
- MIS and open surgery repair
- Where
- Egypt
- Volunteers
- 10 people
- Sponsor
- Jehad Emam Abdelrahman
Congenital Diaphragmatic Hernia
Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH)
The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that…
- Trial name
- NCT07577414
- Testing
- FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Dr Erin Perrone
Congenital Diaphragmatic Hernia
Microbiome and Volatile Organic Compounds in Patients With CDH
Despite improved prenatal diagnostics and therapeutic possibilities, congenital diaphragmatic hernia (CDH) represents a cross-disciplinary challenge.
- Trial name
- CDHVOCS (NCT03787160)
- Testing
- initial VOC, initial fecal microbiome, initial pulmonary microbiome
- Where
- Austria
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Safety and Efficacy of FETO in CDH: A Phase III Trial
Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen.
- Trial name
- CHOP FETO (NCT06884423)
- Testing
- FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Holly L Hedrick, MD
Congenital Diaphragmatic Hernia, Tracheoesophageal Fistula
Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery
The study is primarily a descriptive study examining the physiological, ventilatory, surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic surgery and to determine the accuracy of transcutaneous…
- Conditions
- Congenital Diaphragmatic Hernia, Tracheoesophageal Fistula, Esophageal Atresia
- Trial name
- NCT02033772
- Testing
- Thoracoscopic surgery
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Arlyne Thung
Diaphragmatic Hernia, Oesophageal Atresia
Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)
Observational longitudinal study in children operated at birth on diaphragmatic hernia and/or oesophageal atresia : assessment of lung function parameters; assessment of quality of life and cognitive development; assessment of…
- Trial name
- CDH-EA (NCT02466451)
- Testing
- Questionnaires
- Volunteers
- 33 people
- Sponsor
- Stefania La Grutta, MD
Congenital Diaphragmatic Hernia, Acute Kidney Injury
Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia
The main aim of this project is to elucidate the incidence of acute kidney injury (AKI) in newborns with congenital diaphragmatic hernia during stay in the Pediatric intensive care unit. (PICU).
- Conditions
- Congenital Diaphragmatic Hernia, Acute Kidney Injury, Multiple Organ Failure, Pulmonary Hypertension
- Trial name
- NCT06050525
- Where
- Sweden
- Volunteers
- 109 people
- Sponsor
- Karolinska Institutet
Congenital Diaphragmatic Hernia
Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants With Congenital Diaphragmatic Hernia (CDH)
The purpose of this study is to investigate the use of autologous umbilical cord blood (UCB) mononuclear cells to mitigate hypoxic neurologic injury among infants with high-risk congenital diaphragmatic hernia (CDH).
- Trial name
- NCT03526588
- Testing
- Autologous umbilical cord blood
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- The University of Texas Health Science Center, Houston