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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: 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: 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: NCT05461222 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

FETO
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.

NCT ID: NCT05450653 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Trial of FETO for Severe Congenital Diaphragmatic Hernia

FETO
Start date: September 18, 2022
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 Ann & Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.

NCT ID: NCT05201144 Recruiting - Clinical trials for Pulmonary Hypertension

A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH)

Start date: September 15, 2022
Phase: Phase 2
Study type: Interventional

Congenital diaphragmatic hernia (CDH) occurs in approximately 1 in 3000 US live births, similar to the incidence seen within the Utah Birth Defects cohort. The diaphragmatic defect compromises lung growth and alters pulmonary vascular development. This is reflected postnatally as respiratory failure, pulmonary hypertension (PH) and overall cardiopulmonary dysfunction, particularly post-repair. Currently, optimal management of post-repair PH remains poorly investigated. Sildenafil citrate is a highly selective phosphodiesterase-5 inhibitor that increases cGMP levels, leading to smooth muscle relaxation and an anti-proliferative effect within the pulmonary vasculature. It is used off-label for many neonatal PH disorders, including PH associated with bronchopulmonary dysplasia and idiopathic persistent PH. Most neonates with CDH born within the Mountain West referral basin are managed at a quaternary care center, Primary Children's Hospital (PCH). Of these neonates with PH, approximately 25% have been treated with off-label sildenafil. However, neither the PCH clinical care group nor others have developed/published a standardized approach for either initiating or discontinuing sildenafil therapy in this group of patients. Thus, the aim of this study is to assess the safety and effectiveness of sildenafil therapy for PH in neonates with CDH within the Utah cohort. Given the relatively short-term outcome and small sample size for this trial, the plan is to use this data to support a larger multicenter randomized trial targeting long-term cardiopulmonary outcomes of infants with CDH and post-repair PH.

NCT ID: NCT05100693 Recruiting - Clinical trials for Congenital Diaphragmatic Hernia

Smart Removal for Congenital Diaphragmatic Hernia

SmartRemoval
Start date: September 8, 2021
Phase: N/A
Study type: Interventional

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 and moderate to severe pulmonary hypoplasia.

NCT ID: NCT05051254 Recruiting - Lung Diseases Clinical Trials

Respiratory Muscles and Work of Breathing in Children

WOB&MR_Ped
Start date: January 19, 2022
Phase: N/A
Study type: Interventional

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 of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management. The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.