Evidence map›Paper›PMID 40889095›Full record

ArticleClinical pharmacokinetics2025

Paracetamol Concentrations and Time-Course of Ductus Arteriosus Diameter in Extremely Preterm Neonates: A Population Pharmacokinetic-Pharmacodynamic Analysis.

Faheemah Padavia, Jean-Marc Treluyer, Gilles Cambonie, Cyril Flamant, Aline Rideau, Manon Tauzin, Juliana Patkai, Géraldine Gascoin, Mirka Lumia, Outi Aikio and 15 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Clinical pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04459117 (Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04459117 phase2 / phase3completednot on this map

Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen

TypeinterventionalSponsorInstitut National de la Santé Et de la Recherche Médicale, FranceRan2020 to 2024Enrolled804ConditionsPatency of the Ductus Arteriosus, Acetaminophen, Extreme PrematurityArmsAcetaminophen, NACL 0.9%
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Faheemah PadaviaUniversité Paris Cité, Inserm, Pharmacologie et évaluation des thérapeutiques chez l'enfant et la femme enceinte, 75006, Paris, France. faheemah.padavia@aphp.fr.ORCID 0009-0004-0085-3959
Jean-Marc TreluyerUniversité Paris Cité, Inserm, Pharmacologie et évaluation des thérapeutiques chez l'enfant et la femme enceinte, 75006, Paris, France.
Gilles CambonieDepartment of Neonatal Medicine and Pediatric Intensive Care, Arnaud de Villeneuve Hospital, Montpellier University Hospital, Montpellier, France.
Cyril FlamantDepartment of Neonatalogy, CHU Nantes, Nantes, France.
Aline RideauDepartment of Pediatrics, Robert Debré Hospital, APHP, Paris, France.
Manon TauzinNeonatal Intensive Care Unit, Centre Hospitalier Intercommunal de Créteil, Créteil, France.
Juliana PatkaiNeonatalogy Department, Port-Royal Hospital, Paris, France.
Géraldine GascoinDepartment of Neonatalogy, Angers University Hospital, Angers, France.
Mirka LumiaDepartment of Children and Adolescents, New Children's Hospital, Pediatric research Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Outi AikioDepartment of Pediatrics and Adolescent Medicine, Oulu University Hospital, and Research Unit of Clinical Medicine and MRC Oulu, University of Oulu, Oulu, Finland.
Frantz FoissacUniversité Paris Cité, Inserm, Pharmacologie et évaluation des thérapeutiques chez l'enfant et la femme enceinte, 75006, Paris, France.
Saïk UrienUniversité Paris Cité, Inserm, Pharmacologie et évaluation des thérapeutiques chez l'enfant et la femme enceinte, 75006, Paris, France.
Sihem BenaboudUniversité Paris Cité, Inserm, Pharmacologie et évaluation des thérapeutiques chez l'enfant et la femme enceinte, 75006, Paris, France.
Gabrielle LuiUniversité Paris Cité, Inserm, Pharmacologie et évaluation des thérapeutiques chez l'enfant et la femme enceinte, 75006, Paris, France.
Léo Froelicher BournaudUniversité Paris Cité, Inserm, Pharmacologie et évaluation des thérapeutiques chez l'enfant et la femme enceinte, 75006, Paris, France.
Yi ZhengService de Pharmacologie Clinique, Hôpital Cochin, AP-HP, Groupe Hospitalier Paris Centre, Paris, France.
Ruth KemperEuropean Foundation for the Care of Newborn Infants, Munich, Germany.
Marine TortigueNantes Université, CHU Nantes, CNRS, Inserm, l'institut du thorax, Nantes, France.
Alban-Elouen BaruteauNantes Université, CHU Nantes, CNRS, Inserm, l'institut du thorax, Nantes, France.
Jaana KallioDepartment of Children and Adolescents, New Children's Hospital, Pediatric research Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Mikko HallmanDepartment of Pediatrics and Adolescent Medicine, Oulu University Hospital, and Research Unit of Clinical Medicine and MRC Oulu, University of Oulu, Oulu, Finland.
Alpha DialloClinical Trial Safety and Public Health, ANRS Emerging Infectious Diseases, Paris, France.
Léa LevoyerClinical Trial Safety and Public Health, ANRS Emerging Infectious Diseases, Paris, France.
Jean-Christophe RozeNantes Université, CHU Nantes, Inserm, CIC FEA 1413, Nantes, France.
Naïm BouazzaUniversité Paris Cité, Inserm, Pharmacologie et évaluation des thérapeutiques chez l'enfant et la femme enceinte, 75006, Paris, France.

Funding

Innovative Medicines Initiative 777389
6 · The paper itself

Abstract

backgroundPatent ductus arteriosus is a common complication of extreme prematurity. Prophylactic treatment with indomethacin or ibuprofen has shown efficacy on ductus closure but without reducing mortality and morbidity. Prophylactic treatment by paracetamol could be a safer alternative.

objectiveThe aim was to build a pharmacokinetic-pharmacodynamic (PKPD) model describing the effect of paracetamol on the time-course of the ductus arteriosus diameter.

methodsExtremely preterm neonates of 23-26 weeks of gestational age were recruited within 12 h after birth and were treated with prophylactic intravenous paracetamol for 5 days (two dose levels: 20 mg/kg followed by 7.5 mg/kg or 25 mg/kg followed by 10 mg/kg every 6 h). The diameter of ductus arteriosus was determined by echocardiography performed daily until day 7. The PKPD model was built using an I

resultsA total of 29 extremely preterm neonates with median birth weight of 800 g (IQR: 670-860) were included in the study. Between-subject variability was estimated on transfer rate constant between the central compartment and the effect compartment (ke

conclusionThe relationship between paracetamol and the time-course of ductus arteriosus diameter has been described in extremely preterm neonates. Intravenous paracetamol treatment with a loading dose of 25 mg/kg within 12 h after birth followed by 10 mg/kg every 6 h appears to be effective to accelerate time to ductus closure with limited benefit of a further dose increase.

Indexed as

AcetaminophenDuctus ArteriosusDuctus Arteriosus, PatentInfant, Extremely PrematureModels, BiologicalDose-Response Relationship, DrugEchocardiographyFemaleGestational AgeHumansInfant, NewbornMaleAcetaminophen

Identifiers

PMID40889095

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.