View clinical trials related to Ductus Arteriosus, Patent.
Filter by:The study aims to evaluate the clinical presentation and course of PDA diagnosed at neonatal period in the neonatology unit of Assiut University Hospital for Children.
Establish a cardiovascular biomarker profile to help screening for congenital heart disease in infants and children as well as use non-invasive cardiac imaging in combination with such profiling to better predict the need for future cardiac interventions such as open heart surgery or cardiac catheter intervention selected types of with congenital heart disease.
The aim of this study is to investigate whether there is a relationship between echocardiographic measurements regarding closure of PDA and serum D-Dimer and Fibrinogen levels in premature infants born before 32nd gestational week and weighing less than 1500 grams.
The aim of this study was to evaluate the effect of paracetamol on patent ductus arteriosus (PDA) closure and clinical outcomes in preterm infants when used as standard intermittent bolus and continuous intravenous (IV) infusion. Preterm neonates with birth weight (BW) ≤1500 g and gestational age (GA) ≤32 weeks were included in this study. During the study period, IV paracetamol therapy was given to all infants with hemodynamically significant patent ductus arteriosus (hsPDA). The patients were divided into the standard IV intermittent bolus infusion group and the continuous IV infusion group.
TREOCAPA is a Phase II/III European Multicentre study concerning the prophylactic treatment by Acetaminophen of extremely preterm infant during the first five days after birth. The Phase II is a dose finding phase in order to assess the minimum effective dose regimen of acetaminophen for the closure of PDA for neonates with a gestational age less than 27 weeks This part of the study will be conducted in 11 NICUs, in 4 countries (France, UK, Finland and Denmark). The Phase III is The phase III is a randomized, multicenter, double-blind, placebo-controlled superiority trial, two arms in a 1:1 ratio, evaluating an increasing of 10% of the percentage of survival without severe morbidity at 36 weeks of post menstrual age. In the intervention arm, 20 mg/kg followed by 7.5 mg/kg quarter in die (QID) will be administered to the 27-28 weeks gestational age group (dosage confirmed through PK/PD data analysis from the previous Finnian study) and the dosage selected after the conclusion of the Phase II will be administered to the 23-26 weeks gestational age group. A group sequential design, with a total of 3 analyses (2 interim analyses and a final) and the O'Brien-Fleming alpha spending function is chosen for the trial. At the same time, a Bayesian sequential analysis is planned for safety endpoints
The aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in preterms
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization.
To evaluate whether utilizing a standardized patent ductus arteriosus (PDA) treatment algorithm in managing ELBW (extremely low birth weight) neonates ≤1000 grams (g) improves clinical outcomes and helps prevent undesirable side effects from PDAs.
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect safety and efficacy information for evaluating the results of its clinical use.
Respiratory distress syndrome (RDS) is among the most common complications of preterm birth, and typically becomes manifested soon after birth. A failure of the rapid reuptake of fetal lung fluids after birth, with subsequent liquid retention in the alveolar space, together with the deficit of surfactant proteins ensuing from lung immaturity represent the leading mechanisms for the development of RDS, which may require different levels of respiratory support. An increasingly used method for the evaluation of the neonatal lung is pulmonary ultrasound, which allows assessing alveolar fluids and other pathological conditions in a non-invasive manner, and has been shown to predict the need for respiratory support and for surfactant administration in preterm infants with RDS. However, this method requires specific training, is operator-dependent and does not provide a trend able assessment over time. Transthoracic electrical bioimpedance (TEB) allows continuous and non-invasive monitoring of static and dynamic thoracic fluids. It has been recently introduced in neonatal clinical practice to assess such hemodynamic parameters as cardiac output and also quantifies static thoracic fluids contents (TFC). This method provides continuous and non-operator dependent data on the pulmonary fluid status over time and does not require specific training. The combination of lung ultrasound with TEB could open to new diagnostic and prognostic perspectives in preterm infants with RDS.