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Hernia, Diaphragmatic clinical trials

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NCT ID: NCT06408376 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Physiological Umbilical Cord Clamping in Patients With Congenital Diaphragmatic Hernia. Clinical Trial

Start date: June 14, 2022
Phase: N/A
Study type: Interventional

Congenital diaphragmatic hernia (CDH) is a malformation that affects 1 in every 3000 newborns. The diaphragm does not complete its closure during embryogenesis, which allows the abdominal organs to herniate into the thoracic cavity altering lung development. The lungs of patients with CDH are small, with a decreased surface area for gas exchange and developmental impair of the pulmonary vasculature, resulting in respiratory failure and pulmonary hypertension shortly after birth. When clamping the umbilical cord, a large part of the preload is abruptly excluded, generating an increase in vascular resistance, which in turn increase the afterload, resulting in a decrease in cardiac output. The output is restored by decreasing vascular resistance in pulmonary circuit after lung aeration upon receiving the preload of the right atrium, increasing pulmonary flow and thus sustaining the preload of the left ventricle. If pulmonary aeration occurs before clamping the umbilical cord, the pulmonary blood flow increases before placenta flow is lost, thus avoiding a decrease in cardiac output. This modality has been called physiological base cord clamping (PFC). The hypothesis is that PFC once ventilation has been established could prevent hypoxia and improve cardiac output in newborns with CDH and secondarily improve their hemodynamic parameters, stabilizing gas exchange and pulmonary hypertension during the first 24 hours of birth.

NCT ID: NCT06281717 Not yet recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth. This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age.

NCT ID: NCT06179472 Not yet recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Fetoscopic Endoluminal Tracheal Occlusion for Severe Left and Right Congenital Diaphragmatic Hernia

Start date: January 15, 2025
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the feasibility and efficacy of performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of the BALT Goldbal2 balloon at the UW Health Fetal Diagnosis and Treatment Center which resides in UnityPoint Health-Meriter (UPH-Meriter) hospital as well as the American Family Children's Hospital (AFCH). We hypothesize that FETO balloon placement and removal can be performed safely at our institution and may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe left or right congenital diaphragmatic hernia (CDH).

NCT ID: NCT06064188 Recruiting - Clinical trials for Congenital Diaphragmatic Hernias

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Start date: September 6, 2023
Phase: N/A
Study type: Interventional

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

NCT ID: NCT06050525 Recruiting - Acute Kidney Injury Clinical Trials

Incidence of Acute Kidney Injury and Risk Factors in Newborns With Congenital Diaphragmatic Hernia

Start date: February 1, 2023
Phase:
Study type: Observational

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). This patient group often presents with severe circulatory and respiratory dysfunction requiring intensive care treatment. Characterization of risk factors to AKI will also be performed.

NCT ID: NCT05985564 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Retrospective Comparative Study on Imaging Between the Bochdalek Hernia and Congenital Diaphragmatic Eventration

Start date: March 18, 2022
Phase:
Study type: Observational

The imaging manifestations of diaphragmatic hernia and diaphragmatic distension were retrospectively analyzed and summarized, combined with the surgical findings, to summarize the differences in indirect signs of diaphragmatic hernia and diaphragmatic distension, so as to achieve the purpose of differential diagnosis.Research contents: (1) To summarize the characteristics of indirect imaging signs in patients with diaphragmatic hernia, to sum up the incidence of each sign, to find new signs and the prognosis of each sign; (2) Summarize the characteristics of indirect imaging signs in patients with diaphragmatic distension, summarize the incidence of each sign, and search for new signs and the prognosis of each sign; (3) To summarize the differences in indirect signs of diaphragmatic hernia and diaphragmatic distension, as well as the differences in their incidence, and combined with their surgical findings, to summarize their image identification points

NCT ID: NCT05962346 Enrolling by invitation - Clinical trials for Congenital Diaphragmatic Hernia

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

FETO
Start date: May 2025
Phase: N/A
Study type: Interventional

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. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).

NCT ID: NCT05839340 Active, not recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias

NAN-C
Start date: May 26, 2023
Phase: N/A
Study type: Interventional

Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Our dual-centre randomised cross-over trial aims to investigate the efficacy of NIV-NAVA compared to ACV for supporting neonates with CDH.

NCT ID: NCT05771688 Recruiting - Clinical trials for Hernia, DIaphragmatic, Congenital

Fetoscopic Endoluminal Tracheal Occlusion

FETO
Start date: February 22, 2024
Phase: N/A
Study type: Interventional

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 Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.

NCT ID: NCT05666986 Not yet recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia

CHASAM
Start date: March 2023
Phase:
Study type: Observational

The objective is to understand how a population of adolescents - who have undergone diaphragm surgery within their first month of life (i.e. subjects who have been carriers of a rare impacting disease such as congenital diaphragmatic hernia (CDH)) - engages in physical and sports activities and what can be the hindering factors as well as the factors facilitating these practices. Based on self-questionnaires and semi-structured interviews, this research is a qualitative research in the field of human and social sciences. The qualitative survey will make it possible to report on the experience of the disease of children and parents; in parallel, a complete medical evaluation of the subjects (clinical and para-clinical) will be carried out. The analysis of the verbatim of the self-questionnaires and interviews with regard to the real physical capacities of the subjects, will be discussed.