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Patent Ductus Arteriosus clinical trials

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NCT ID: NCT03982342 Terminated - Clinical trials for Patent Ductus Arteriosus

Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants

PIVOTAL
Start date: October 10, 2020
Phase: N/A
Study type: Interventional

This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA). The PDA closes after birth for most term infants, but in many preterm infants, it remains open (patent). A PDA may present a complication for a number of short-term problems faced by preterm infants. Longer-term issues include the development of pulmonary hypertension and changes in the size and performance of the heart. There is ongoing debate as to whether or not the PDA requires intervention.

NCT ID: NCT03701074 Terminated - 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: NCT03537144 Terminated - Clinical trials for Patent Ductus Arteriosus

Acetaminophen vs Indomethacin in Treating hsPDA

Start date: June 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: NCT03026192 Terminated - Clinical trials for Patent Ductus Arteriosus

Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure

Start date: December 2016
Phase:
Study type: Observational

Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.

NCT ID: NCT00961753 Terminated - Clinical trials for Patent Ductus Arteriosus

Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates

OIDS
Start date: August 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.

NCT ID: NCT00833365 Terminated - Prematurity Clinical Trials

Early Versus Late Use of Ibuprofen for PDA Closure

Start date: January 2009
Phase: N/A
Study type: Interventional

The primary objective is to evaluate the PDA closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old. The secondary objective is to measure the stress hormone and metabolic response (plasma catecholamines, glucose, and lactate) of neonates undergoing Ibu treatment of the PDA. The investigators believe that early ibuprofen will blunt the stress response greater than later use.

NCT ID: NCT00802685 Terminated - Clinical trials for Patent Ductus Arteriosus

Timing of PDA Closure and Respiratory Outcome in Premature Infants

Start date: November 2007
Phase: N/A
Study type: Interventional

The investigators propose the present study with the following aims: - to determine whether early patent ductus arteriosus (PDA) treatment with ibuprofen treatment at the onset of clinical symptoms is superior to late ibuprofen treatment only when symptoms of a hemodynamically significant PDA are present in the evolution of bronchopulmonary dysplasia (BPD) defined as duration of supplemental oxygen exposure during the first 28 days - to determine whether early PDA treatment with ibuprofen will be superior to late treatment with ibuprofen in efficacy of PDA closure, need for rescue therapy, need for PDA ligation and incidence of major complications of prematurity. Hypothesis: Early pharmacologic closure of PDA with ibuprofen will improve respiratory course and reduce BPD as reflected by a reduction in duration of supplemental oxygen during the first 28 days of age vs. late pharmacologic treatment with ibuprofen. Outcome variables: The primary outcome of this study is the number of days spent on supplemental oxygen by each infant during the first 28 days. Other outcomes to be determined between groups include: - Mortality - Other respiratory variables: total days on supplemental oxygen, days on mechanical ventilation, oxygen dependence at 36 weeks post menstrual age, age at final extubation. - Other respiratory complications: pneumothorax, pulmonary interstitial emphysema, need for high frequency ventilation, pulmonary hypertension - Efficacy of PDA closure: number of courses of medication required, need for ligation - Other neonatal complications: intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intestinal perforation, sepsis, renal dysfunction (oliguria, elevated creatinine) - Time to achieving full enteral feedings, time to regain birth weight, weight at discharge. - Length of hospital stay

NCT ID: NCT00767039 Terminated - Clinical trials for Respiratory Distress Syndrome

Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants

CAST
Start date: January 2005
Phase: Phase 4
Study type: Interventional

Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.

NCT ID: NCT00750581 Terminated - Clinical trials for Patent Ductus Arteriosus

An Escalating Dose Indomethacin for the Treatment of Persistent Patent Ductus Arteriosus (PDA) In Preterm Infants

Start date: August 2008
Phase: Phase 2/Phase 3
Study type: Interventional

A large patent ductus arteriosus (PDA) is associated with congestive heart failure, pulmonary hemorrhage, chronic lung disease (CLD), necrotizing enterocolitis (NEC) and intraventricular bleeding. Indomethacin is the first line of treatment for PDA. Failure of ductal closure with the first course of indomethacin is reported in 30-40% of infants, with a higher failure rate in infants weighing < 1000 gm. PDA ligation is associated with early postoperative hypotension, oxygenation failure and adverse neurodevelopmental outcome in preterm infants. The use of escalating doses of Indomethacin in the treatment of persistent PDA was found to be safe and decreased the need for PDA ligation without adverse effects in one observational study.We hypothesize that the use of an escalated dose of intravenous indomethacin will result in an increase in the probability of survival without need for surgical ligation of PDA as compared to a standard dose indomethacin in newborn infants < 29 weeks of gestational age with persistent PDA.