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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.
To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
Eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours.
One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral paracetamol | Active Comparator | Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours. |
|
| Oral ibuprofen | Active Comparator | Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral paracetamol | Drug | Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen | To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment | Until discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants | Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated. | corrected 36 weeks or until discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Yekta Oncel, MD | Zekai Tahir Burak Women's Health Research and Education Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology | Ankara | 06110 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36519620 | Derived | Jasani B, Mitra S, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants. Cochrane Database Syst Rev. 2022 Dec 15;12(12):CD010061. doi: 10.1002/14651858.CD010061.pub5. | |
| 28395364 | Derived | Oncel MY, Eras Z, Uras N, Canpolat FE, Erdeve O, Oguz SS. Neurodevelopmental Outcomes of Preterm Infants Treated with Oral Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus. Am J Perinatol. 2017 Oct;34(12):1185-1189. doi: 10.1055/s-0037-1601564. Epub 2017 Apr 10. |
| Label | URL |
|---|---|
| Ibuprofen | View source |
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| Oral ibuprofen | Drug | Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. |
|
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| 24359938 | Derived | Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, Canpolat FE, Dilmen U. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18. |
| Paracetamol | View source |
| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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