Active clinical trials for "Hernias, Diaphragmatic, Congenital"

To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia.

Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.

The objective is to evaluate the quality of the response to the Blood Oxygen Level Dependent effect in fetuses with diaphragmatic hernias and abdominal wall malformations and to correlate with postnatal respiratory outcome. Pulmonary involvement is a constant in diaphragmatic hernias, it is classic in omphaloceles and especially hepatomphaloceles, and exceptional in laparoschisis. As this is an original exploratory study, no preliminary data are available. If a correlation is found, the Blood Oxygen Level Dependent effect of the fetal lung may be considered as an early functional marker of postnatal lung function. It can be used in addition to lung-to-head-ratio during prenatal counseling. The final goal is to be able to detect early in the fetus pulmonary insufficiency to help prenatal counseling and perinatal care.

the aim of this study is to compare the effect of different modes of mechanical ventilation by using volume-controlled ventilation and pressure-controlled ventilation on cerebral blood flow monitored by cerebral oximetry during thoracoscopic surgeries in neonates.

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

We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway inflammation as a first step to characterize the reported bronchodilator responsiveness. Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to document the amount and type of inflammation present. Another ancillary non-invasive measure of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective of this study is to determine if CDH patients have any evidence of airway inflammation. The hypothesis of this study is that children with CDH do not have evidence of airway inflammation associated with bronchodilator responsiveness. Based on this information, treatment for CDH patients will hopefully be more accurate and appropriate for their specific needs.

Congenital diaphragmatic hernia (CDH) has an incidence of 1:2200 to 1:4000 newborns. The survival rate depends on the extent of the lung hypoplasia and pulmonary hypertension. In case of an observed / expected total fetal lung volume ratio (o/e TFLV) ratio of 25% or lower and herniation of the liver in thorax, the postnatal survival is estimated to be 10-25% or lower. The aim of fetoscopic tracheal balloon occlusion is to positively influence the lung growth in CDH fetuses avoiding the development of lung hypoplasia. Some complications after sucsessfull FETO before delivery occur because of technical difficulties during the extraction of the balloon from the trachea, leading to asphyxia, worse outcome or neonatal demise. Jani et al. published 10 neonatal deaths from 210 FETO directly related to difficulties with the removal of the intratracheal balloon. The risk of emergent balloon removal was published to be very high (39%-56%). Our new technique exploits the fetal ability to removal the intratracheal balloon which has been implanted for the treatment of severe CDH before the delivery, avoiding many risks associated with balloon extraction and a second fetoscopy. The study will be performed on 20 fetuses with severe CDH. Before the FETO the total fetal lung volume ratio (o/e TFLV) will be measured by fetal MRI (magnetic . Only CDH fetuses with 24-32 weeks' gestation with o/e TFLV < 25% or the fetuses with o/e TFLV < 35% and liver herniation will be operated Second fetal MRI should be performed in one week after the FETO. The balloon will be extracted by the fetus itself before the delivery, after puncture with 22 gauge needle under ultrasound guiding, during second fetoscopy or using the EXIT (ex utero intrapartum Treatment). Neonatal follow up 12 months.

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 vascularization. Fetal endoscopic tracheal occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal pulmonary response followed FETO can be used to predict outcome and is dependent on the size of the fetal lung prior to the procedure. We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form of CDH will have a better fetal pulmonary response and higher chance of surviving.

The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is higher than 90% due to severe pulmonary hypoplasia. Many studies have suggested that fetal tracheal occlusion may increase lung volumes and therefore reducing the risk for severe pulmonary hypoplasia and by consequence the risk for neonatal death. The main objective of the present study is to evaluate if fetal tracheal occlusion improves survival rate in those cases that are followed in our hospital, by conducing a randomized trial.

Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.