Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus
NCT ID: NCT04037514
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
133 participants
INTERVENTIONAL
2017-07-07
2024-12-18
Brief Summary
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Detailed Description
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The PARACETAMOL group will receive intravenous doses of 15 mg/kg administered every 6h for 3 days (up to a maximum of 2 courses, i.e. 6 days). The IBUPROFEN group (control group) will receive the usual treatment, this is an initial dose of 10 mg/kg followed by 5 mg/kg intravenously at 24 and 48 hours after the first (all three doses are considered a treatment course), up a maximum of 2 courses).
A daily echocardiographic control will be performed to evaluate the closure of the ductus. If the ductus remains open and with significant clinical repercussion after completing a 3-day course of treatment, another batch of 3 doses of the same treatment will be administered. If medical treatment fails after two courses (6 days), the possibility of administering a batch of Ibuprofen at usual doses in both groups with the intention of offering standard treatment to all patients will be considered. Once the medical treatment with both drugs is completed if the ductus remains significant, the surgical closure will be carried out.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Paracetamol
Intravenous paracetamol 15 mg/kg/6h for 3 or 6 days
Paracetamol
Intravenous paracetamol 15 mg/kg/6h
Ibuprofen
Intravenous ibuprofen 10 mg/kg/24 h (day 1) and 5 mg/kg/24h (day 2 and 3) for 3 or 6 days
Ibuprofen
Intravenous ibuprofen 10 mg/kg/24h (day 1) and 5 mg/kg/24h (day 2 and 3)
Interventions
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Paracetamol
Intravenous paracetamol 15 mg/kg/6h
Ibuprofen
Intravenous ibuprofen 10 mg/kg/24h (day 1) and 5 mg/kg/24h (day 2 and 3)
Eligibility Criteria
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Inclusion Criteria
* Gestacional Age ≤30 weeks
* Postnatal age ≤ 2 weeks
* Need for ventilatory support
* Born in participating hospital/arrival to them within the period of application of the treatment
* 1 st episode of hemodynamically significant Patent Ductus Arteriosus
Exclusion Criteria
* Refusal to participate and / or sign the informed consent.
* Impossibility or erroneous randomization
* Participation in another clinical trial with drugs
* Diuresis less than 1 ml / kg / h for 8 h prior to treatment
* Greater than 1.8 mg / dl Creatinine
* Platelets below 50,000 / uL
* Active bleeding (tracheal, gastrointestinal and renal)
* Intraventricular hemorrhage recently (48h) (grades 3-4)
* Severe hyperbilirubinemia
* Liver failure or severe coagulopathy
* Active necrotizing enterocolitis or intestinal perforation
* Septic shock
* Imminent death
14 Days
ALL
No
Sponsors
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Instituto de Investigacion Sanitaria La Fe
OTHER
Spanish Clinical Research Network - SCReN
NETWORK
Máximo Vento Torres
OTHER
Responsible Party
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Máximo Vento Torres
Scientific Director Health Research Institute La Fe
Principal Investigators
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Maximo Vento Torres, PhD, MD
Role: STUDY_CHAIR
Hospital Universitario La Fe
Locations
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Hospital Reina Sofía
Córdoba, Cordoba, Spain
Hospital Universitario de Cabueñes
Gijón, Gijón, Spain
Hospital Materno-Infantil (Hospital Regional Carlos Haya) Málaga:
Málaga, Málaga, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, Spain
Countries
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References
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Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. PLoS One. 2013 Nov 4;8(11):e77888. doi: 10.1371/journal.pone.0077888. eCollection 2013.
Hammerman C, Bin-Nun A, Markovitch E, Schimmel MS, Kaplan M, Fink D. Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment. Pediatrics. 2011 Dec;128(6):e1618-21. doi: 10.1542/peds.2011-0359. Epub 2011 Nov 7.
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.
Yang B, Gao X, Ren Y, Wang Y, Zhang Q. Oral paracetamol vs. oral ibuprofen in the treatment of symptomatic patent ductus arteriosus in premature infants: A randomized controlled trial. Exp Ther Med. 2016 Oct;12(4):2531-2536. doi: 10.3892/etm.2016.3676. Epub 2016 Sep 6.
Dash SK, Kabra NS, Avasthi BS, Sharma SR, Padhi P, Ahmed J. Enteral paracetamol or Intravenous Indomethacin for Closure of Patent Ductus Arteriosus in Preterm Neonates: A Randomized Controlled Trial. Indian Pediatr. 2015 Jul;52(7):573-8. doi: 10.1007/s13312-015-0677-z.
Sancak S, Gokmen Yildirim T, Topcuoglu S, Yavuz T, Karatekin G, Ovali F. Oral versus intravenous paracetamol: which is better in closure of patent ductus arteriosus in very low birth weight infants? J Matern Fetal Neonatal Med. 2016;29(1):135-9. doi: 10.3109/14767058.2014.989829. Epub 2014 Dec 23.
El-Khuffash A, Jain A, Corcoran D, Shah PS, Hooper CW, Brown N, Poole SD, Shelton EL, Milne GL, Reese J, McNamara PJ. Efficacy of paracetamol on patent ductus arteriosus closure may be dose dependent: evidence from human and murine studies. Pediatr Res. 2014 Sep;76(3):238-44. doi: 10.1038/pr.2014.82. Epub 2014 Jun 18.
Garcia-Robles A, Gimeno Navarro A, Serrano Martin MDM, Parraga Quiles MJ, Parra Llorca A, Poveda-Andres JL, Vento Torres M, Aguar Carrascosa M. Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol. Front Pediatr. 2020 Jul 17;8:372. doi: 10.3389/fped.2020.00372. eCollection 2020.
Other Identifiers
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IBUPAR-TRIAL
Identifier Type: -
Identifier Source: org_study_id