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Ductus Arteriosus, Patent clinical trials

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NCT ID: NCT06298344 Not yet recruiting - Clinical trials for Congenital Heart Disease

The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

Start date: March 1, 2024
Phase: Early Phase 1
Study type: Interventional

Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions.

NCT ID: NCT06256211 Not yet recruiting - Clinical trials for Patent Ductus Arteriosus

Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates

Start date: March 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

To compare the effectiveness of rectal vs. intravenous paracetamol in the medical treatment of significant PDA in neonates.

NCT ID: NCT06153771 Recruiting - Clinical trials for Extremely Premature Newborn (Born Before 32 Weeks' Gestation)

Description of Changes in NIRS as a Function of Ductus Arteriosus Status in Very Premature Babies Born Before 32 WG at the DIJON University Hospital

CAPNIRS
Start date: October 16, 2023
Phase:
Study type: Observational

Monitoring patent ductus arteriosus is currently performed using echocardiography, an operator-dependent examination which requires holding the child on their back and which is potentially time-consuming. This test is usually carried out on days 2, 4 and 7 after birth. NIRS (near-infrared spectroscopy) is a non-invasive method of monitoring tissue oxygen saturation using infrared light. The aim of the study was to investigate an association between cerebral and renal NIRS data and ductus arteriosus status obtained by echocardiography.

NCT ID: NCT06152796 Not yet recruiting - Clinical trials for Patent Ductus Arteriosus

Comparision Between Paracetamol and Ibuprofen in Closure of Patent Ductus Arteriosus

Start date: December 1, 2023
Phase: Phase 2
Study type: Interventional

To compare efficacy and safety of paracetamol and ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in preterm infants.

NCT ID: NCT06064825 Recruiting - Clinical trials for Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity

Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)

TREOCAPA-LT
Start date: December 12, 2023
Phase:
Study type: Observational

The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus arteriosus (PDA). In these patients, PDA has been associated with increased mortality and morbidity in the neonatal period, and neonatal morbidities may in turn be associated with later deficits in cognitive functioning. PDA treatment with COX inhibitors, as ibuprofen or indomethacin, aiming at closing the PDA have been associated with numerous adverse effects and failed to demonstrate significant clinical benefits. Early treatment of PDA with paracetamol (acetaminophen ) has been proposed as an alternative to COX inhibitors. The ongoing pan-European TREOCAPA phase III study (NCT04459117) is a multicentre, double-blind, randomised, placebo-controlled superiority trial that assesses prophylactic use of paracetamol to improve survival without severe neonatal morbidity until discharge from hospital in infants of 23-28 weeks of gestational age. As long-term follow-up was not planned by the TREOCAPA protocol, TREOCAPA-LT study will use an existing European research infrastructure, the RECAP Preterm platform (https://recap-preterm.eu/), to follow-up the patients enrolled in the TREOCAPA trial using a parent-report questionnaire at 2 years of corrected age. The TREOCAPA-LT primary hypothesis is that there will be improved cognitive outcome at 2 years of corrected age in children born at less than 29 weeks of gestational age who were treated with paracetamol during the first 5 days of life in the TREOCAPA phase III trial.

NCT ID: NCT06045130 Not yet recruiting - Sepsis Clinical Trials

PUFAs in Preterm Infants

PIPI
Start date: September 21, 2023
Phase:
Study type: Observational

The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.

NCT ID: NCT05987202 Recruiting - Clinical trials for Persistent Ductus Arteriosus

Betamethasone and Closure of Ductus Arteriosus

CELESTE
Start date: May 1, 2023
Phase:
Study type: Observational

The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality: prolongation of respiratory assistance, pulmonary haemorrhage, -necrotizing enterocolitis (NECU), intraventricular haemorrhage and death. PDA management is one of the most discussed aspects in neonatology. The treatment is either conservative (controlled fluid intake, monitoring of cerebral flows, diuretics), or pharmacological (ibuprofen or paracetamol per os), or surgical (thoracotomy + ligature or catheterization + plug). The success rate of pharmacological treatment of CAP is 30% in the most immature children. When medical treatment fails, surgical or endovascular treatment is considered. However, these are associated with complications such as recurrent nerve lesion, thoracotomy, failure to close DA, migration of the plug. Therefore individualized assessment balances the expected benefits of CAP treatment against the risks associated with the treatments for each patient. The main complication of CAP is the impossibility of weaning the patient from ventilatory assistance. On the one hand because of PDA, but also very often because of the concomitant development of bronchopulmonary dysplasia (BPD) due to pulmonary lesions secondary to assisted ventilation and especially to inflammation. At 3 weeks of life, if attempts at ventilatory weaning have failed, postnatal corticosteroid therapy is considered in the 4th week of life in accordance with current recommendations. The most commonly used postnatal corticosteroids are dexamethasone (DXM), hydrocortisone hemisuccinate (HSHC) and betamethasone (BTM). DXM (intravenous) is effective and is the most widely used product worldwide, but its use is associated with impaired postnatal growth and suboptimal neurodevelopment. HSHC (intravenous) is an alternative to DXM and has shown some effectiveness, without the adverse effects of DXM. The BTM is also an alternative, but has been used less than the other products because it is not widely available in some countries. Its advantage is that it can be given orally, but there is little published data on the effect of BTM. In this context, it has been used in some neonatal units and have shown some effectiveness. In the Neonatology department of the Croix Rousse hospital, oral BTM has been used since 2005 and has been evaluated favorably, since it allows the child to be weaned from ventilatory assistance. When using BTM, we observed not only a positive respiratory effect, but also DA closure, reducing the need for ligation of the ductus arteriosus by surgery or catheterization

NCT ID: NCT05922488 Completed - Ductus Arteriosus Clinical Trials

Effect of Umbilical Cord Milking Versus Clamping in Preterms on Cerebral Oxygenation and Ductus Arteriosus Closure

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

All patients will be subjected to the following: 1-Umbilical cord milking or delayed cord clamping according to the ranamization table 2 serial measurement of cerebral tissue oxygenation 3- serial echocardiography for ductus arteriosus (DA)functional closure

NCT ID: NCT05686343 Recruiting - Clinical trials for Patent Ductus Arteriosus After Premature Birth

Hemodynamically Important Patent Ductus Arteriosus in Newborns Under 32 Weeks

Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

To define the characteristics of hemodynamically significant PDA by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal Doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with NIRS in newborns below 32 weeks of age with PDA.

NCT ID: NCT05639309 Recruiting - Premature Birth Clinical Trials

Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

Start date: January 13, 2023
Phase:
Study type: Observational

This study evaluates the usefulness of liver perfusion and oxygenation status using regional oxygen saturation (RSO2) values obtained via near-infrared spectroscopy in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants.