Evidence map›Paper›PMID 38389165›Full record

ReviewActa paediatrica (Oslo, Norway : 1992)2024

Practical approaches for supporting informed consent in neonatal clinical trials.

Susan H Wootton, Matthew Rysavy, Peter Davis, Marta Thio, Mar Romero-Lopez, Lindsay F Holzapfel, Tamara Thrasher, Jaleesa D Wade, Louise S Owen

Abstract readReview
In one paragraph

Review in Acta paediatrica (Oslo, Norway : 1992), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. 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

9 authors.

Susan H WoottonDivision of Infectious Diseases, Department of Pediatrics, McGovern Medical School at UTHealth Houston, Houston, Texas, USA.ORCID 0000-0002-2596-4311
Matthew RysavyInstitute for Clinical Research and Learning Health Care, McGovern Medical School at UTHealth Houston, Houston, Texas, USA.
Peter DavisNewborn Research, Neonatal Services, Royal Women's Hospital, Melbourne, Australia.
Marta ThioNewborn Research, Neonatal Services, Royal Women's Hospital, Melbourne, Australia.
Mar Romero-LopezInstitute for Clinical Research and Learning Health Care, McGovern Medical School at UTHealth Houston, Houston, Texas, USA.
Lindsay F HolzapfelChildren's Memorial Hermann Hospital, Houston, Texas, USA.
Tamara ThrasherChildren's Memorial Hermann Hospital, Houston, Texas, USA.
Jaleesa D WadeDivision of Neonatology, Department of Pediatrics, McGovern Medical School at UTHealth, Houston, Texas, USA.
Louise S OwenNewborn Research, Neonatal Services, Royal Women's Hospital, Melbourne, Australia.

Funding

Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
Institutional Career Development CoreKL2TR003168 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MILLER, CHARLES C · 2019 to 2023
$4.9M
NICHD Neonatal Research Network (NRN): Clinical Centers (UG1 Clinical Trial OptionalUG1HD112093 · NICHD · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI Matthew Albert Rysavy · 2023 to 2026
$1.4M
Development and evaluation of a risk-based approach to target vitamin A therapy to prevent bronchopulmonary dysplasia among very low birth weight infantsF32HD098782 · NICHD · UNIVERSITY OF IOWA · PI RYSAVY, MATTHEW ALBERT · 2019 to 2020
$140k
NCATS NIH HHS 5KL2TR003168NCATS NIH HHS KL2 TR003168NCATS NIH HHS UL1 TR003167NICHD NIH HHS F32 HD098782NICHD NIH HHS L40 HD099827NICHD NIH HHS L40 HD109887NICHD NIH HHS UG1 HD112093
6 · The paper itself

Abstract

The survival and health of preterm and critically ill infants have markedly improved over the past 50  years, supported by well-conducted neonatal research. However, newborn research is difficult to undertake for many reasons, and obtaining informed consent for research in this population presents several unique ethical and logistical challenges. In this article, we explore methods to facilitate the consent process, including the role of checklists to support meaningful informed consent for neonatal clinical trials.

conclusionThe authors provide practical guidance on the design and implementation of an effective consent checklist tailored for use in neonatal clinical research.

Indexed as

ChecklistInformed ConsentCritical IllnessHumansInfant, Newbornchecklistsclinical trialsethicsinformed consentneonatology

Identifiers

PMID38389165
PMCPMC11006570

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.