RT Journal Article
T1 Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol.
A1 García-Robles, Ana
A1 Gimeno Navarro, Ana
A1 Serrano Martín, María Del Mar
A1 Párraga Quiles, María José
A1 Parra Llorca, Anna
A1 Poveda-Andrés, José Luis
A1 Vento Torres, Máximo
A1 Aguar Carrascosa, Marta
K1 ductus
K1 efficacy
K1 paracetamol
K1 pharmacogenetics
K1 pharmacokinetics
K1 safety
AB Background: Currently, the first line treatment of persistent ductus arteriosus (PDA) is either indomethacin or ibuprofen. However, the potentially life-threatening side effects associated to their use have prompted physicians to look for alternative options. The incorporation of paracetamol as an alternative to ibuprofen in the management of PDA is still based on insufficient clinical evidence. Hence, more clinical trials are needed to establish a therapeutic role for paracetamol in the management of PDA that take into consideration short- and long-term safety and efficacy outcomes. Study Design: This is a non-inferiority, randomized, multicenter, double-blinded study to evaluate the efficacy, and safety of intravenous (IV) paracetamol vs. IV ibuprofen (standard treatment) for PDA in preterm patients with a gestational age ≤ 30 weeks. At baseline, patients will be randomized (1:1) to treatment with paracetamol or ibuprofen. The primary endpoint is closure of the ductus after the first treatment course. Secondary endpoints are related to effectiveness (need for a second treatment course, rescue treatment, reopening rate, time to definitive closure, need for surgical ligation), safety (early and long-term complications), pharmacokinetics, and pharmacodynamics, pharmacogenetics, pharmacoeconomics, and genotoxicity. Long-term follow-up to 24 months of corrected postnatal age will be performed using Bayley III neurodevelopmental scale. Trial Registration: ClinicalTrials.gov Identifier: NCT04037514. EudraCT: 2015-003177-14.
SN 2296-2360
YR 2020
FD 2020-07-17
LK https://hdl.handle.net/10668/25924
UL https://hdl.handle.net/10668/25924
LA en
DS RISalud
RD Apr 7, 2025