Observational studyBritish journal of clinical pharmacology2021
Prospective identification and causality evaluation of suspected adverse drug reactions in neonates.
Observational study in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
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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.
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.
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Who cites it
9 citing papers in PubMed, 21 citations in OpenAlex.
- Preliminary exploration of acute limit toxicity testing for nicotinamide mononucleotide in the neonatal population.Frontiers in pharmacology · 2026Article
- Adverse Drug Reactions in Neonates: How to Detect and Address Signals in the Noise.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- Assessment of severity and avoidability of adverse drug reactions in neonates: a reproducibility study of the Hartwig tool and LAAT.European journal of clinical pharmacology · 2025Observational
- Observational
- Causality assessment of adverse drug reactions in neonates: a comparative study between Naranjo's algorithm and Du's tool.International journal of clinical pharmacy · 2023Observational
- The neonatal adverse event severity scale: current status, a stakeholders' assessment, and future perspectives.Frontiers in pediatrics · 2023Article
- Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper.British journal of clinical pharmacology · 2022Review
- Dose-Related Adverse Drug Events in Neonates: Recognition and Assessment.Journal of clinical pharmacology · 2021Review
- Prospective identification and causality evaluation of suspected adverse drug reactions in neonates.British journal of clinical pharmacology · 2021Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Neonates experience adverse drug reactions (ADRs), but under-reporting of suspected ADRs to national spontaneous reporting schemes in this population is particularly high. A prospective observational study collected suspected neonatal ADRs at a tertiary neonatal unit. Cases were analysed for causality by six assessors using three existing methods. Sixty-three suspected ADR cases were identified in 35/193 neonates (18.1%). The proportion of suspected ADRs where the drug was prescribed "off-label" was 30/68 (44.1%). When 34 cases were assessed for causality using three methods, global kappa scores of less than 0.3 for each tool suggested only "fair" inter-rater reliability. Neonatal ADRs can be captured and occur from a variety of drugs affecting many organ systems. The current tools for assessing causality need to be adapted before they can reliably assess neonatal ADRs.
Indexed as
Identifiers
What OpenQuestion holds
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.