Evidence map›Paper›PMID 41378199›Full record

ArticleFrontiers in pediatrics2025

COVID-19 pandemic and enrollment of critically Ill children in randomized clinical trials.

Sarah B Kandil, David Panisello-Manterola, Madhuradhar Chegondi, Christine Allen, Jill M Cholette, Michele Kong, Matthew Pinto, Hilary Schreiber, Christie Glau, E Vincent S Faustino

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in pediatrics, 2025. 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

10 authors.

Sarah B KandilDepartment of Pediatrics, Section of Critical Care Medicine, Yale University, School of Medicine, New Haven, CT, United States.
David Panisello-ManterolaLake Erie College of Osteopathic Medicine, Elmira, NY, United States.
Madhuradhar ChegondiDivision of Pediatric Critical Care Medicine, University of Illinois College of Medicine, and Children's Hospital of Illinois at OSF HealthCare, Peoria, IL, United States.
Christine AllenDivision of Pediatric Critical Care, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma, OK, United States.
Jill M CholetteDivision of Pediatric Critical Care Medicine, Department of Pediatrics, University of Rochester Golisano Children's Hospital, Rochester, NY, United States.
Michele KongDepartment of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.
Matthew PintoDivision of Pediatric Critical Care Medicine, Department of Pediatrics, Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY, United States.
Hilary SchreiberDepartment of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, United States.
Christie GlauDepartment of Anesthesiology and Critical Care Medicine, University of Pennsylvania Perelman School of Medicine and Children's Hospital of Philadelphia, Philadelphia, PA, United States.
E Vincent S FaustinoDepartment of Pediatrics, Section of Critical Care Medicine, Yale University, School of Medicine, New Haven, CT, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To evaluate the association of the COVID-19 pandemic with enrollment rates of critically ill children in randomized clinical trials (RCT). We hypothesized that enrollment rates declined due to increased parental refusal. Design: Cross-sectional analysis of 2 multicenter RCTs conducted pre- and post-COVID-19. Setting: A total of 5 centers pre-COVID-19 and 15 centers post-COVID-19 conducting pediatric RCTs on enoxaparin prophylaxis against catheter-associated thrombosis. Patients: Critically ill children <18 years old with newly inserted central venous catheters. Interventions: Randomization to enoxaparin prophylaxis or usual care. Measurements: Enrollment rates and reasons for non-enrollment were analyzed in 622 eligible children: 165 pre-COVID-19 (November 2017-August 2019) and 457 post-COVID-19 (May 2022-August 2024). Main results: Enrollment rates declined from 30.9% pre-COVID-19 to 18.2% post-COVID-19 ( Conclusions: The COVID-19 pandemic is associated with lower enrollment rates in RCTs enrolling critically ill children. Increased parental refusal post-pandemic is confounded by reduced research staff availability. Further investigation is needed to assess the role of science denialism and identify strategies to enhance enrollment in RCTs of critically ill children.

Indexed as

pandemicparental consentpatient selectionpediatricsthromboprophylaxis

Identifiers

PMID41378199
PMCPMC12685906

What OpenQuestion holds

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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.