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Patent Ductus Arteriosus clinical trials

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NCT ID: NCT06298344 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: May 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: 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.

NCT ID: NCT05264753 Recruiting - Clinical trials for Patent Ductus Arteriosus

PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

Start date: December 20, 2021
Phase:
Study type: Observational [Patient Registry]

This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech PDA by using Occlutech Occlusions-Pusher (OOP) in patients with patent ductus arteriosus defects. Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation.

NCT ID: NCT04986839 Recruiting - Clinical trials for Patent Ductus Arteriosus

PAIR (Paracetamol and Ibuprofen Research) Pilot Trial

PAIR
Start date: September 3, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Presence of Patent Ductus Arteriosus is detrimental to an infant born prematurely. The primary objective is to study the efficacy of Paracetamol (proposed new treatment) in treating haemodynamic significant Patent Ductus Arteriosus (hsPDA) in comparison to Ibuprofen (current standard treatment) in preterm infants. Outcome of such treatment will check on the conversion of hsPDA to non-hsPDA. All preterm infants (born at <32 weeks gestational age or birth weight < 1500 grams) with haemodynamically significant patent ductus arteriosus (hsPDA) who are ≤ 28 days old will be included over 2 years. Sample size 32. Secondary outcomes of this study will compare 1) BPD (broncho-pulmonary dysplasia) free survival at 36 weeks post menstrual age (PMA), 2) incidence of complications of prematurity in each group and 3) to record any evidence of adverse effects with Paracetamol or Ibuprofen.

NCT ID: NCT04984057 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome

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

In preterm infants with neonatal respiratory distress syndrome (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Otherwise, the international neonatal acute RDS (NARDS) collaborative group provides the first consensus definition for NARDS in 2017. And whether or not PS being beneficial in preterm infants with NARDS remains unknown.

NCT ID: NCT04397913 Recruiting - Clinical trials for Patent Ductus Arteriosus

Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA

Start date: May 25, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT04371081 Recruiting - Clinical trials for Patent Ductus Arteriosus

Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT04270240 Recruiting - Clinical trials for Patent Ductus Arteriosus

A NEW SCORING SYSTEM FOR PREDICTION OF PDA

SIMPLE
Start date: January 15, 2019
Phase:
Study type: Observational

Patent ductus arteriosus (PDA) is an important morbidity of that the diagnosis and treatment is controversy in premature infants. A number of scoring systems have been developed, including the findings of echocardiography on the diagnosis and treatment of PDA. This study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant PDA earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.

NCT ID: NCT03648437 Recruiting - Clinical trials for Patent Ductus Arteriosus

Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus

PAI
Start date: September 3, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this pilot trial is to study efficacy and safety of simultaneous intravenous (iv) ibuprofen/indomethacin and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants. It is randomized, placebo-controlled, double-blind, phase 1, multicenter, clinical trial.

NCT ID: NCT03456336 Recruiting - Infant, Premature Clinical Trials

Management of the PDA Trial

PDA
Start date: December 3, 2018
Phase: Phase 3
Study type: Interventional

Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.