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Ductus Arteriosus, Patent clinical trials

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NCT ID: NCT03782610 Not yet recruiting - Clinical trials for Bronchopulmonary Dysplasia

Early Prediction of Spontaneous Patent Ductus Arteriosus (PDA) Closure and PDA-Associated Outcomes

Start date: April 1, 2019
Study type: Observational [Patient Registry]

Patent ductus arteriosus (PDA), very common in preterm infants, is the delayed closure of a fetal blood vessel that limits blood flow through the lungs. PDA is associated with mortality and harmful long term outcomes including chronic lung disease and neurodevelopmental delay. Although, treatments to close PDA likely benefit some infants, widespread routine treatment of all preterm infants with PDA may not improve important outcomes. Left untreated, most PDAs close spontaneously. Thus, PDA treatment is increasingly controversial and varies markedly between hospitals and individual providers. The relevant and still unanswered clinical question is not whether to treat all preterm infants with PDA, but whom to treat and when. Treatment detriments may outweigh benefits, since all forms of deliberate PDA closure have potential adverse effects, especially in infants destined for early, spontaneous PDA closure. Unfortunately, clinicians cannot currently predict in the 1st month which infants are at highest risk for persistent PDA, and which combination of clinical risk factors, echocardiographic (echo) measurements, and serum biomarkers may best predict PDA-associated harm. The American Academy of Pediatrics has acknowledged early identification of infants at high-risk from PDA as a key research goal for informing future PDA-treatment effectiveness trials. Our objective is to use a prospective cohort of untreated infants with PDA to predict spontaneous ductal closure timing and identify echo measurements and biomarkers that are present in the 1st postnatal month and associated with long-term impairment. Our central hypothesis is that these risk factors can be determined to inform appropriate clinical treatments when necessary. Clinical, serum and urine biomarkers (BNP, NTpBNP, NGAL, H-FABP), and echo variables sequentially collected during each of the first 4 postnatal weeks will be examined. In addition myocardial deformation imaging (MDI) and tissue Doppler imaging (TDI), innovative echo methods, will facilitate the quantitative evaluation of myocardial performance. Aim 1 will estimate the probability of spontaneous PDA closure and predict the timing of ductal closure using echo, biomarker, and clinical predictors. Aim 2 will specify which echo predictors and biomarkers are associated with mortality and severity of respiratory illness at 36-weeks PMA. Aim 3 will identify which echo predictors and biomarkers are associated with 22- to 26-month neurodevelopment. All models will be validated in a separate cohort. This project will significantly contribute to clinical outcomes and PDA management by reducing unnecessary and harmful overtreatment of infants with a high probability of early spontaneous PDA closure, and will permit the development of outcomes-focused trials to examine the effectiveness of PDA closure in those "high-risk" infants most likely to receive benefit.

NCT ID: NCT03723889 Completed - Clinical trials for Patent Ductus Arteriosus

Patent Ductus Arteriosus and Splanchnic Oxygenation at First Feed

Start date: November 1, 2013
Study type: Observational

Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may results in pulmonary hyperperfusion and systemic hypoperfusion. As consequence of splanchnic hypoperfusion ensuing from left-to-right PDA shunting, a possible association between hemodynamically significant PDA and adverse gastrointestinal outcomes has been reported. An impaired blood flow velocity in superior mesenteric artery, evaluated by Doppler ultrasound, has been previously reported before and after feeds in infants with large PDA, whereas evidence on PDA effect on splanchnic tissue oxygenation, measured by Near Infrared Spectroscopy, is scarce and controversial. This study aims to evaluate whether splanchnic oxygenation patterns in response to enteral feeding introduction in preterm infants may be affected by PDA status.

NCT ID: NCT03701074 Recruiting - Clinical trials for Bronchopulmonary Dysplasia

Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus

Start date: December 15, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard treatment strategy of using intravenous ibuprofen alone among preterm infants.

NCT ID: NCT03675425 Active, not recruiting - Clinical trials for Patent Ductus Arteriosus After Premature Birth

The Effects of Phototherapy in Preterm Infants Pda

Start date: July 8, 2018
Phase: N/A
Study type: Interventional

The study was designed to assess whether chest shielding during phototherapy reduces the incidence of PDA, as assessed by serial echocardiographic examinations, in a population of extremely preterm infants born at lower 30 week gestation.

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

Paracetamol And Ibuprofen in Closing Patent Ductus Arteriosus

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 and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants. It is randomized, placebo-controlled, double-blind, phase 1, one center, clinical trial, with an additional open arm.

NCT ID: NCT03604796 Not yet recruiting - Clinical trials for Ductus Arteriosus, Patent

Alternative Paracetamol Treatments for the Neonate With a hsPDA

Start date: September 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. However many extremely low birth weight infants may be on limited or no feeds when PDA closure is determined to be indicated, thus restricting the use of enteral acetaminophen. Several studies have suggested that intravenous acetaminophen is less effective than enteral. Thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.

NCT ID: NCT03551600 Recruiting - Clinical trials for Congenital Heart Disease

Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus

Start date: October 2015
Study type: Observational

Patent ductus arteriosus (PDA) is a common problem in the neonatal intensive care unit and can be secondary to prematurity or congenital heart disease (CHD). PDA is the most common cardiovascular abnormality in preterm infants, and is seen in 55% of infants born at 28 weeks, and 1000 grams or less. In addition to producing heart failure and prolonged respiratory distress or ventilator dependence, PDA has been implicated in development of broncho-pulmonary dysplasia, interventricular hemorrhage, cerebral ischemia, and necrotizing enterocolitis (NEC). In an Israeli population study 5.6% of all very low birth weight infants (VLBW) were diagnosed with NEC, and 9.4% of VLBW infants with PDA were found to have NEC. In a retrospective analysis of neonates with CHD exposed to Prostaglandin E found that the odds of developing NEC increased in infants with single ventricle physiology, especially hypoplastic left heart syndrome. The proposed pathophysiological explanation of NEC and PDA is a result of "diastolic steal" where blood flows in reverse from the mesenteric arteries back into the aorta leading to compromised diastolic blood flow and intestinal hypo-perfusion. Prior studies have demonstrated that infants with a hemodynamically significant PDA have decreased diastolic flow velocity of the mesenteric and renal arteries when measured by Doppler ultrasound, and an attenuated intestinal blood flow response to feedings in the post prandial period compared to infants without PDA. Near Infrared Spectroscopy (NIRS) has also been used to assess regional oxygen saturations (rSO2) in tissues such as the brain, kidney and mesentery in premature infants with PDA. These studies demonstrated lower baseline oxygenation of these tissues in infants with hemodynamically significant PDA. These prior NIRS studies evaluated babies with a median gestational age at the time of study of 10 days or less. It is unknown if this alteration in saturations will persist in extubated neonates with PDA at 12 or more days of life on full enteral feedings. In the present study the investigators hypothesize that infants with a PDA, whether secondary to prematurity or ductal dependent CHD, will have decreased splanchnic and renal perfusion and rSO2 renal/splanchnic measurements will be decreased during times of increased metabolic demand such as enteral gavage feeding. To test this hypothesis the investigators have designed a prospective observational study utilizing NIRS to record regional saturations at baseline, during feedings, and after feedings for 48 hours.

NCT ID: NCT03537144 Recruiting - Clinical trials for Patent Ductus Arteriosus

Acetaminophen vs Indomethacin in Treating hsPDA

Start date: May 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to see if acetaminophen (Tylenol) is as effective as indomethacin in closing patent ductus arteriosus in premature infants.

NCT ID: NCT03456336 Not yet recruiting - Infant, Premature Clinical Trials

Management of the PDA Trial

Start date: May 30, 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.

NCT ID: NCT03289390 Recruiting - Clinical trials for Patent Ductus Arteriosus

Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

Start date: August 1, 2017
Phase: N/A
Study type: Observational

This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.