Related Experiment Video

Updated: Jan 9, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.1K

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

Sarah B Kandil1, David Panisello-Manterola2, Madhuradhar Chegondi3

  • 1Department of Pediatrics, Section of Critical Care Medicine, Yale University, School of Medicine, New Haven, CT, United States.

Frontiers in Pediatrics
|December 11, 2025
PubMed

Insights

The COVID-19 pandemic lowered enrollment for critically ill children in clinical trials. Parental refusal increased, linked to fewer research staff, impacting trial participation.

Area of Science:

  • Pediatric Critical Care Medicine
  • Clinical Trial Management
  • Epidemiology

Background:

  • The COVID-19 pandemic significantly impacted healthcare systems globally.
  • Enrollment in pediatric randomized clinical trials (RCTs) may have been affected.
  • Parental consent is crucial for pediatric RCT participation.

Purpose of the Study:

  • To assess the association between the COVID-19 pandemic and enrollment rates in pediatric RCTs.
  • To investigate changes in reasons for non-enrollment, particularly parental refusal.

Main Methods:

  • A cross-sectional analysis of two multicenter RCTs involving critically ill children was performed.
  • Enrollment data from pre-COVID-19 (November 2017-August 2019) and post-COVID-19 (May 2022-August 2024) periods were compared.
  • Reasons for non-enrollment were analyzed for 622 eligible children.

Main Results:

  • Enrollment rates decreased significantly from 30.9% pre-COVID-19 to 18.2% post-COVID-19 (P=0.001).
  • Parental unavailability decreased, but research staff unavailability increased post-pandemic.
  • Despite similar overall parental refusal rates, enrollment failure due to parental refusal rose post-COVID-19 (64.1% vs. 46.3%, P=0.003).

Conclusions:

  • The COVID-19 pandemic is linked to reduced enrollment in pediatric critical care RCTs.
  • Increased parental refusal post-pandemic is confounded by decreased research staff availability.
  • Further research is needed to understand science denialism's role and improve RCT enrollment strategies.
Abstract

Keywords:
pandemicparental consentpatient selectionpediatricsthromboprophylaxis

More Related Videos

How to Administer Near-Infrared Spectroscopy in Critically ill Neonates, Infants, and Children07:27

How to Administer Near-Infrared Spectroscopy in Critically ill Neonates, Infants, and Children

Published on: August 19, 2020

12.3K
Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies10:38

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies

Published on: January 16, 2019

20.7K

Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
10.1K
Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
194
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
133
Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
240
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
229
Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
174