GuidelineArchives of disease in childhood2019
Development of a neonatal adverse event severity scale through a Delphi consensus approach.
Guideline in Archives of disease in childhood, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06889376 (The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening), which is not on this map. Cited by 41 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.
The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening
Who cites it
41 citing papers in PubMed, 69 citations in OpenAlex.
- Video versus direct laryngoscopy to improve the success rate of nasotracheal intubations in the neonatal intensive care setting: a randomised controlled trial.BMJ paediatrics open · 2023Trial
- Development and validation of the neonatal safety assessment scale in disasters (NSASD).BMC nursing · 2026Article
- Randomised Phase 2b trial of rhIGF-1/rhIGFBP-3 (OHB-607) for bronchopulmonary dysplasia prevention in preterm neonates: study protocolBMJ paediatrics open · 2026Article
- Pharmacokinetics and safety of fosfomycin and flomoxef administered as part of neonatal sepsis treatment (NeoSep1 Part 1).Antimicrobial agents and chemotherapy · 2026Article
- Updated recommendations for the design of therapeutic trials for neonatal seizures.Pediatric research · 2026Review
- Article
- 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
- A Retrospective Analysis of PK and Response of Oral Ibuprofen in the Treatment of a Patent Ductus Arteriosus in Extremely Low Gestational Age Neonates.Journal of clinical pharmacology · 2025Article
- Article
- Article
- Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach.International breastfeeding journal · 2025Article
- Safety reporting in neonatal clinical trials: reflections towards optimal, globally relevant approaches.Trials · 2025Article
- A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology.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
- Adverse events in the neonatal intensive care unit identified by triggers.Frontiers in pharmacology · 2025Article
- Clusters and associations of adverse neonatal events with adult risk of multimorbidity: A secondary analysis of birth cohort data.PloS one · 2025Article
- Article
- Publication Recommendations to Report Laboratory Data of Neonates - a Modified Delphi Approach.Pediatric research · 2024Article
- Adverse drug reactions in neonates: a brief analysis of the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
- Editorial: Research challenges of drug utilization, data collection, data validation, and adverse drug reactions in neonates.Frontiers in pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 14 institutions in 6 countries.
Funding
Abstract
backgroundAssessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed.
methodsA stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation.
resultsNeonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available. DISCUSSION: The INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.
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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.