Evidence map›Paper›PMID 41626218›Full record

ArticleResuscitation plus2026

Informed consent, randomization, and blinding in neonatal resuscitation and immediate care trials.

Reetta Karvinen, Daniele De Luca, Ilari Kuitunen

Abstract read
In one paragraph

Article in Resuscitation plus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

3 authors.

Reetta KarvinenUniversity of Eastern Finland, Institute of Clinical Medicine and Department of Pediatrics, Kuopio, Finland.
Daniele De LucaDivision of Pediatrics and Neonatal Critical Care, "A.Beclere" Hospital, APHP-Paris Saclay University, Paris, France.
Ilari KuitunenUniversity of Eastern Finland, Institute of Clinical Medicine and Department of Pediatrics, Kuopio, Finland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Aim: To analyze how the informed consent process, blinding and randomization were conducted in neonatal resuscitation trials. Data sources: PubMed, Scopus and Web of Science were searched for randomized controlled trials published between 2016 and 2025 and focusing on neonatal resuscitation and acute care during the first six hours of life. Both studies conducted in delivery rooms and neonatal intensive care units were included. Two authors screened the results and extracted the data. Results: We screened 567 abstracts, and further assessed 174 full texts, of which 143 were included. From included studies, 108 (75.5%) used written informed consent and the consent was prospective in 89 (62.2%) of the studies. Cochrane's risk of bias tool 2 was used: the bias due to randomization was low in 126 (88.1%) studies and high in only 3.5% of studies. During the study period there was a trend towards less bias due to randomization as the linear regression indicated an improvement in the low risk of bias rate. Personnel blinding was performed in 26 (18.2%) studies, assessor blinding in 56 (39.2%), and data analysis blinding in 29 (20.3%) of the included studies. Conclusion: Written prospective informed consent was the most used consent method in neonatal emergency situations. Bias due to randomization was generally low but blinding was performed in a minority of studies. These findings provide suggestion to improve the quality of future neonatal resuscitation trials.

Indexed as

BlindingConsentEpidemiologyMethodologyNeonatal resuscitation

Identifiers

PMID41626218
PMCPMC12856276

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Registered trials

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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.