Clinical trials: Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Fetal Surgery
Fetal Surgery for Moderate Left Sided Congenital Diaphragmatic Hernia.
Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and remains associated with a 30 % chance of perinatal death and morbidity mainly because of pulmonary hypoplasia and pulmonary hypertension.
- Conditions
- Congenital Diaphragmatic Hernia, Fetal Surgery, Pulmonary Hypoplasia
- Trial name
- TOTAL moderate (NCT00763737)
- Testing
- Fetoscopic Endoluminal Tracheal Occlusion
- Where
- 13 sites in United States, Australia and 8 more
- Volunteers
- 196 people
- Sponsor
- University Hospital, Gasthuisberg
Pulmonary Hypertension of Newborn, Diaphragm Defect
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
The purpose of this study is to evaluate the effect of a parenteral emulsion containing n-3 long-chain polyunsaturated fatty acids (LC-PUFA) in fish oil on clinical outcomes, markers of inflammation and oxidative stress, and pain…
- Trial name
- CDH-PPHN-N3 (NCT04031508)
- Testing
- lipid injectable emulsion with Fish oil
- Where
- Mexico
- Volunteers
- 40 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Congenital Diaphragmatic Repair
Analysis of in Vitro Biological Reaction of Diaphragmatic Prothesis When Congenital Diaphragmatic Hernia (CDH) Repair
In case of CDH, the incomplete development of a part of the diaphragm allows abdominal viscera to herniate into thorax cavity during fetal development and impaired lung and heart development.
- Trial name
- NCT03316924
- Testing
- Foreskin resection
- Where
- France
- Volunteers
- 1 people
- Sponsor
- University Hospital, Strasbourg, France
Congenital Diaphragmatic Hernia
Resuscitation of Infants With Congenital Diaphragmatic Hernia With an Intact Umbilical Cord
Congenital diaphragmatic hernia (CDH) is a severe birth defect, with a prevalence of 1:2000 to 1:3000 live births where a defect in the diaphragm results in, herniation of the abdominal contents into the chest with subsequent…
- Trial name
- NCT03242044
- Testing
- Congenital diaphragmatic hernia resuscitation with an intact umbilical cord
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Colorado, Denver
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