Future of clinical trials in the delivery room: time for pragmatism.


Journal

Archives of disease in childhood. Fetal and neonatal edition
ISSN: 1468-2052
Titre abrégé: Arch Dis Child Fetal Neonatal Ed
Pays: England
ID NLM: 9501297

Informations de publication

Date de publication:
Mar 2023
Historique:
received: 27 06 2022
accepted: 01 09 2022
pubmed: 27 9 2022
medline: 25 2 2023
entrez: 26 9 2022
Statut: ppublish

Résumé

Despite increased amounts of research, most of the evidence that supports treatment of newborns in the delivery room is rated 'low' rather than 'high' quality. This assessment stems largely from a lack of evidence from clinical trials. When trials have been performed, the evidence has often been downgraded due to enrolment of small or poorly representative samples, and for lack of blinding of caregivers and outcome assessors. Delivery room trials present particular challenges when obtaining consent, enrolling participants, taking measures to limit bias and identifying appropriate outcome measures. We hope our suggestions as to how future delivery room trials could be more pragmatic will inform the design of large studies that are necessary to allow clinical practice to evolve.

Identifiants

pubmed: 36162974
pii: archdischild-2022-324387
doi: 10.1136/archdischild-2022-324387
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

102-105

Informations de copyright

© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Auteurs

Colm Patrick Finbarr O'Donnell (CPF)

Neonatal Unit, National Maternity Hospital, Dublin, Ireland codonnell@nmh.ie.
School of Medicine, University College Dublin School of Medicine, Dublin, Ireland.

Janneke Dekker (J)

Pediatrics, Division of Neonatology, Leiden University Medical Center, Leiden, The Netherlands.

Mario Rüdiger (M)

Department for Neonatology and Paediatric Intensive Care Medicine; Medizinische Fakultät, Technische Universitat Dresden, Dresden, Germany.
Saxony Centre for Feto-Neonatal Health, Medizinische Fakultät, Technische Universitat Dresden, Dresden, Germany.

Arjan B Te Pas (AB)

Neonatology, Leiden University Medical Center, Leiden, The Netherlands.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH