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Ductus Arteriosus, Patent clinical trials

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NCT ID: NCT01758913 Completed - Clinical trials for Patent Ductus Arteriosus

Closure of Patent Ductus Arteriosus With Indomethacin or Ibuprofen in Extreme Low Birth Weight Infants

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

Pharmacological closure of ductus arteriosus with prostaglandin (PG) inhibitors has been used for years. Previous studies indicated that ibuprofen has similar effect on ductal closure as indomethacin but has less adverse effects on renal function, cerebral blood flow and mesenteric blood flow.1-7 There are, however, very few studies being done specifically on extremely low birth weight (ELBW) infant < 1000 g. This group of infants has immature kidney and often has poor response to PG inhibitors and has high mortality and morbidity. We hypothesized that, in ELBW infants, the ductal and renal response to PG inhibitors may be different between indomethacin and ibuprofen.

NCT ID: NCT01630278 Completed - Clinical trials for Patent Ductus Arteriosus

Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)

TRIOCAPI
Start date: March 2012
Phase: Phase 3
Study type: Interventional

Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.

NCT ID: NCT01593163 Completed - Clinical trials for Patent Ductus Arteriosus

Echocardiographically Guided Versus Standard Ibuprofen Treatment for Patent Ductus Arteriosus

Start date: May 2009
Phase: Phase 3
Study type: Interventional

Patent ductus arteriosus (PDA) is a very common condition in immature newborn babies and it has been associated to morbidity and mortality. Ibuprofen is the drug of choice for PDA treatment according to the last version of the Cochrane review. Nowadays the best dose regimen for ibuprofen remains uncertain. The investigators aim to perform a randomized controlled clinical trial to assess whether echocardiographically guided PDA ibuprofen treatment versus standard treatment could reduce the number of doses of ibuprofen without increasing the reopening rate and reducing the side effects associated to this medication.

NCT ID: NCT01544972 Recruiting - Clinical trials for Patent Ductus Arteriosus

Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants

Start date: February 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.

NCT ID: NCT01536158 Completed - Clinical trials for Patent Ductus Arteriosus

Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial

Start date: February 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

NCT ID: NCT01511887 Completed - Clinical trials for Patent Ductus Arteriosus

Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)

Start date: January 2011
Phase: N/A
Study type: Interventional

The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.

NCT ID: NCT01497054 Completed - Clinical trials for Patent Ductus Arteriosus

Do Elevated BNP Levels Predict Hemodynamically Significant PDAs

Start date: December 2011
Phase: N/A
Study type: Observational

The purpose of this study is to determine if B type natriuretic peptide (BNP) levels can be used to predict a hemodynamically significant patent ductus arteriosus (PDA). This peptide is produced by the ventricles in the heart when they are under stress, such as when a ductus remains open. If we can use a simple and inexpensive blood test to determine whether a PDA needs to be treated, we can potentially treat infants sooner than if they needed to wait for the availability of a cardiologist to perform an echocardiogram. This might decrease some of the deleterious effects of PDAs on the preterm infant such as bronchopulmonary dysplasia, necrotizing enterocolitis, renal hypoperfusion, and pulmonary hemorrhage. In a situation where follow up echocardiogram after a course of medical therapy shows persistent PDA, this test may help to decide whether this baby needs further treatment, either medical or surgical.

NCT ID: NCT01479218 Completed - Clinical trials for Patent Ductus Arteriosus

Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Start date: November 2011
Phase: N/A
Study type: Interventional

The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.

NCT ID: NCT01428180 Completed - Clinical trials for Patent Ductus Arteriosus

Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

Start date: April 2011
Phase: Phase 4
Study type: Observational

The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.

NCT ID: NCT01400737 Recruiting - Clinical trials for Oral Ibuprofen Prophylaxis in Very Low Birth Weight Infants

Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants

OIP
Start date: July 2011
Phase: N/A
Study type: Interventional

Patent ductus arterioses (PDA) is a major morbidity in preterm infants, especially in extremely premature infants less than 28 weeks. The clinical signs and symptoms of PDA in preterm infants are non specific and insensitive for making an early diagnosis of significant ductal shunting. Functional echocardiography is emerging as a new valuable bedside tool for early diagnosis of hemodynamically significant ductus, even though there are no universally accepted criteria for grading the hemodynamic significance. Echocardiography has also been used for early targeted treatment of ductus arterioses, though the long term benefits of such strategy are debatable. The biomarkers like BNP and N- terminal pro-BNP are currently under research as diagnostic marker of PDA. The primary mode of treatment for PDA is pharmacological closure using cyclo-oxygenase inhibitors with closure rate of 70-80%. Oral ibuprofen is emerging as a better alternative especially in Indian scenario where parenteral preparations of indomethacin are unavailable and side effects are comparatively lesser. Though pharmacological closure of PDA is an established treatment modality, there is still lack of evidence for long term benefits of such therapy as well as there is some evidence for the possible adverse effects like increased ROP and BPD rates, especially if treated prophylactically.The aim of this study is to investigate the effect of oral ibuprofen prophylaxis administrated on the first 24 hours of life and the following two days on hemodynamically significant patent ductus arterioses and its long term effects such as ROP and BPD.