Clinical trials: Congenital Diaphragmatic Hernias
Fetal Surgery, Myelomeningocele
Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery
Open maternal-fetal surgery is currently used on fetuses with myelomeningocele (MMC). Fetoscopic or minimal access fetal surgery is also being used to treat fetuses with congenital diaphragmatic hernia (CDH).
- Conditions
- Fetal Surgery, Myelomeningocele, Congenital Diaphragmatic Hernia
- Trial name
- NCT03788122
- Testing
- In-depth interview
- Where
- 2 sites in Belgium, United Kingdom
- Volunteers
- 40 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Congenital Diaphragmatic Hernia
Initiation of Resuscitation While Attached to the Cord With Congenital Diaphragmatic Hernia
This study aims to measure the cardio-respiratory physiological consequences of initiating resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with congenital diaphragmatic hernia (CDH).
- Trial name
- INSPIRE-CDH (NCT03094039)
- Testing
- Ventilatory support while attached to the cord, Immediate cord clamping
- Where
- Canada
- Sponsor
- University of Alberta
Congenital Diaphragmatic Hernia
Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH).
- Trial name
- FETO (NCT05461222)
- Testing
- Balt "Goldballoon"
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Yair Blumenfeld
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
Type of Material in Repair of Congenital Diaphragmatic Hernia
The objective of this study is to evaluate the use of 2 different types of biosynthetic material for the repair of congenital diaphragmatic hernia.
- Trial name
- NCT00257946
- Testing
- Repair of CDH w/SIS Gold, Repair of CDH w/Alloderm
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Children's Mercy Hospital Kansas City
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
Congenital Diaphragmatic Hernia
Trial of FETO for Severe Congenital Diaphragmatic Hernia
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann \& Robert H.
- Trial name
- FETO (NCT05450653)
- Testing
- FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Aimen F. Shaaban, 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
Congenital Diaphragmatic Hernia
Smart Removal for Congenital Diaphragmatic Hernia
The purpose of this study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for fetoscopic endoluminal tracheal occlusion (FETO) in fetuses with congenital diaphragmatic hernia…
- Trial name
- SmartRemoval (NCT05100693)
- Testing
- Fetoscopic Endoluminal Tracheal Occlusion with the Smart-TO Balloon
- Where
- Belgium
- Volunteers
- 25 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Oesophageal Atresia, Congenital Diaphragmatic Hernia
Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries
This study is a multi-centre, international, prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.
- Conditions
- Oesophageal Atresia, Congenital Diaphragmatic Hernia, Intestinal Atresia, Gastroschisis
- Trial name
- NCT03666767
- Testing
- Comparisons will be made between LMICs and HICs
- Where
- United Kingdom
- Volunteers
- 3,850 people
- Sponsor
- King's College London
Congenital Diaphragmatic Hernia, Congenital Diaphragmatic Eventration
Genetic Analysis of Congenital Diaphragmatic Disorders
The purpose of this study is to understand the genetic causes of congenital diaphragmatic disorders (CDD), namely congenital diaphragmatic hernia (CDH), eventration and hiatal hernia. Specifically, the investigators plan to: 1.
- Conditions
- Congenital Diaphragmatic Hernia, Congenital Diaphragmatic Eventration, Congenital Hiatal Hernia, Congenital Diaphragmatic Disorders
- Trial name
- NCT01243229
- Where
- 2 sites in United States
- Volunteers
- 305 people, healthy volunteers welcome
- Sponsor
- University of Utah
Congenital Diaphragmatic Hernia
Fetoscopic Endoluminal Tracheal Occlusion (FETO) With Smart-TO
The purpose of this study is to make the proof of concept and to evaluate the safety of fetoscopic endoluminal tracheal occlusion (FETO) using Smart-TO device in fetuses with congenital diaphragmatic hernia and moderate to severe…
- Trial name
- Smart-FETO (NCT04931212)
- Testing
- FETO with Smart-TO balloon
- Where
- 2 sites in France
- Volunteers
- 23 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hernia, DIaphragmatic, Congenital
Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional Ventilation.
Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with significant mortality and respiratory morbidity, particularly related to prolonged mechanical ventilation.
- Trial name
- NAVA-DIAPH (NCT03250793)
- Testing
- Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
- Where
- France
- Volunteers
- 8 people
- Sponsor
- Hospices Civils de Lyon
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
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
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
Persistent Fetal Circulation Syndrome, Diaphragmatic Hernia
Antibody Secreting Cell and Cyotokine Profiles in Neonates on ECMO
Infants are placed on ECMO for correction of reversible respiratory failure. Often, because a few of the reasons for respiratory failure show us similar things in the baby, it is difficult to determine exactly which is causing…
- Conditions
- Persistent Fetal Circulation Syndrome, Diaphragmatic Hernia, Meconium Aspiration, Sepsis
- Trial name
- NCT00371241
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- The University of Texas Health Science Center, Houston
Congenital Diaphragmatic Hernia
Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia
The objective is to understand how a population of adolescents - who have undergone diaphragm surgery within their first month of life (i.e.
- Trial name
- CHASAM (NCT05666986)
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Congenital Diaphragmatic Hernias
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
- Trial name
- FETO (NCT02530073)
- Testing
- Fetoscopic Endoluminal Tracheal Occlusion (FETO)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Connecticut Children's Medical Center
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