Evidence map›Paper›PMID 37745081›Full record

ArticleFrontiers in pharmacology2023

Prospective assessment of inter-rater reliability of a neonatal adverse event severity scale.

Thomas Salaets, Thierry Lacaze-Masmonteil, Isamu Hokuto, Cheri Gauldin, Amjad Taha, Anne Smits, Liesbeth Thewissen, Ilse Van Horebeek, Armuchou Shoraisham, Khorshid Mohammad and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2023. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT06889376 phase1not yet recruitingnot on this mapstarted 2025, after this paper: background citation

The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening

TypeinterventionalSponsorPolish Mother Memorial Hospital Research InstituteRan2025 to 2025Enrolled40ConditionsDrug SafetyArmsIntranasal midazolam administration via the DART™ intranasal atomization device along with routine comfort care.
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. The state of infant massage use in neonatal intensive care units.Journal of perinatology : official journal of the California Perinatal Association · 2026
    Article
  2. Review
  3. 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 · 2025
    Article
  4. 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 · 2025
    Article
  5. Article
  6. Article
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

16 authors.

Thomas SalaetsDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.
Thierry Lacaze-MasmonteilDepartment of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Isamu HokutoDepartment of Pediatrics, St. Marianna University School of Medicine, Kawasaki, Japan.
Cheri GauldinDepartment of Pediatrics, Kansas Children's Mercy Hospital, University of Missouri Kansas City School of Medicine, Kansas City, MO, United States.
Amjad TahaDepartment of Pediatrics, Kansas Children's Mercy Hospital, University of Missouri Kansas City School of Medicine, Kansas City, MO, United States.
Anne SmitsDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.
Liesbeth ThewissenNeonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.
Ilse Van HorebeekNeonatal Intensive Care Unit, St. Augustinus, GZA Hospitals, Antwerp, Belgium.
Armuchou ShoraishamDepartment of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Khorshid MohammadDepartment of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Manami SuzukiDepartment of Pediatrics, St. Marianna University School of Medicine, Kawasaki, Japan.
Shiori KomachiDepartment of Pediatrics, St. Marianna University School of Medicine, Kawasaki, Japan.
Kurt MichelsCritical PATH Institute, Tucson, AZ, United States.
Mark A TurnerInstitute of Lifecourse and Medical Sciences, Liverpool Health Partners, University of Liverpool, Liverpool, United Kingdom.
Karel Allegaert *Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
Tamorah Lewis *Department of Pediatrics, Kansas Children's Mercy Hospital, University of Missouri Kansas City School of Medicine, Kansas City, MO, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

adverse event (AE)clinical trialdata standardsdrug developmentdrug safetyneonatal

Identifiers

PMID37745081
PMCPMC10512550

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.