Clinical trials: Congenital Diaphragmatic Hernia, open to volunteers
Congenital Diaphragmatic Hernia
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic.
- Trial name
- FETO (NCT05962346)
- Testing
- BALT GOLDBALL 2 detachable latex ballon, BALTACCIBDPE100 Microcatheter, Storz fetoscopic operating sheath and miniature telescope/fetoscope
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mauro H. Schenone
Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia
Palliative Care Needs of Children With Rare Diseases and Their Families
The palliative care needs of family caregivers of children with rare diseases and their children are largely unmet, including the need for support to prepare for future medical decision making.
- Conditions
- Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia, Asparagine Synthetase Deficiency, CHARGE Syndrome
- Trial name
- FACE-Rare (NCT06938542)
- Testing
- Family Centered pediatric palliative care for family caregivers of children with rare diseases.
- Where
- United States
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Children's National Research Institute
Rare Diseases, Congenital Diaphragmatic Hernia
Intact Cord Resuscitation in CDH
Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20…
- Trial name
- CHIC (NCT04429750)
- Testing
- Immediate umbilical cord clamping, intact cord resuscitation
- Where
- 3 sites in France
- Volunteers
- 180 people
- Sponsor
- University Hospital, Lille
Congenital Diaphragmatic Hernia
Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia
The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic Hernia (CDH).
- Trial name
- NCT06946576
- Testing
- Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Oregon Health and Science University
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
- Conditions
- Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary; Hypertension
- Trial name
- FETO (NCT02986087)
- Testing
- Fetal Tracheal Occlusion
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Congenital Diaphragmatic Hernia
Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH
Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax.
- Trial name
- NCT03980717
- Testing
- Goldbal Detachable Balloon and delivery microcatheter
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Michael A Belfort
Congenital Diaphragmatic Hernia
Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science
The goal of this study is to identify genes that convey susceptibility to congenital diaphragmatic hernia in humans. The identification of such genes, and examination of their structure and function, will enable a delineation of…
- Trial name
- DHREAMS (NCT00950118)
- Where
- 14 sites in United States, Egypt
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Columbia University
Congenital Diaphragmatic Hernia
3D Animation and Models to Aid Management of Fetal CDH
We wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH.
- Trial name
- NCT03750266
- Testing
- No intervention data collected through routine scans
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
Congenital Diaphragmatic Hernia
Preliminary Study of Pediatric Diaphragmatic Elastography
This diaphragmatic elastography study is a preliminary pilot study to have first values of diaphragmatic stiffness in patients with a history of diaphragmatic hernia and to estimate the difference in stiffness compared to a group…
- Trial name
- ECHODIA (NCT06666140)
- Testing
- Ultrasonic elastography
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Strasbourg, France
Neuromuscular Diseases, Congenital Diaphragmatic Hernia
Respiratory Muscles and Work of Breathing in Children
Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology…
- Conditions
- Neuromuscular Diseases, Congenital Diaphragmatic Hernia, Lung Diseases, Cardiac Diseases
- Trial name
- WOB&MR_Ped (NCT05051254)
- Testing
- Esogastric pressure measurement
- Where
- France
- Volunteers
- 550 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
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
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
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, 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
Fetoscopic Endoluminal Tracheal Occlusion
The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH).
- Trial name
- FETO (NCT03674372)
- Testing
- Fetoscopic Endoluminal Tracheal Occlusion (FETO)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Colorado, Denver