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https://repository.monashhealth.org/monashhealthjspui/handle/1/56919| Title: | Paracetamol and Patent Ductus Arteriosus closure: Pharmacokinetic-Pharmacodynamic study | Monash Health Investigator(s): | Pharande P. | Monash Health Department(s): | Paediatric - Neonatal (Monash Newborn) | Registration Date: | 20-Nov-2023 | Monash Health Site(s): | Monash Children's Hospital | Summary: | Preterm babies are born with a patent ductus arteriosus (PDA), a blood vessel which connects major blood vessels of heart (aorta) and lung (pulmonary artery). PDA can be associated with complications in preterm babies. Therefore, we try to close it with medications, like paracetamol. However, we still don’t succeed in closing a PDA in 30-35% babies. It is possible, that the dose, which we currently provide, may not be enough for some babies. It is still unknown how much paracetamol concentration (level) is needed to achieve a PDA closure. The aim of this study is to measure the concentration and develop a pharmacokinetic-pharmacodynamic (PK-PD) model of paracetamol in preterm babies. This study will enable us to find the appropriate target concentration necessary for PDA closure. We will be able to use this information to vary the dose of paracetamol to achieve higher success rate in preterm babies in future. | Type: | Clinical trial | Registry ID: | ACTRN12623001197628 | URL: | https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386396 |
| Appears in Collections: | Clinical Trials |
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