Review of Outcomes Used in Nutrition Trials in Pediatric Critical Care

Kunal R Gadhvi1,2, Frédéric V Valla2,3, Lyvonne N Tume1,2

  • 1Bristol Royal Hospital for Children, Bristol, UK.

Insights

Pediatric intensive care (PIC) nutrition trials show wide variation in outcome measures and definitions. Standardizing key nutrition and non-nutrition outcomes is crucial for future research and evidence generation in PIC settings.

Area of Science:

  • Pediatric Intensive Care
  • Clinical Nutrition Research
  • Evidence-Based Medicine

Background:

  • Generating robust evidence in pediatric intensive care (PIC) is challenging due to small patient numbers and heterogeneity.
  • Systematic reviews face limitations from non-standardized outcome measures and definitions.
  • The increasing number of nutrition intervention trials in PIC necessitates an examination of current outcome measures.

Purpose of the Study:

  • To systematically describe the outcome measures utilized in randomized controlled trials evaluating nutrition interventions in PIC.
  • To identify variations and inconsistencies in outcome reporting within this field.

Main Methods:

  • A systematic literature review was conducted for PIC nutrition intervention trials published between January 1, 1996, and February 20, 2018.
  • Twenty-nine trials, involving 3226 patients, were analyzed.

Main Results:

  • A total of 37 primary and 83 secondary outcomes were identified, categorized into PIC-related (infection, dependency, organ dysfunction, mortality) and nutrition-specific outcomes (energy targets, nutrition parameters, feeding tolerance).
  • Significant variation was observed in the chosen outcome measures.
  • Key outcome domains, including energy targets, feeding tolerance, and infection, lacked adequate definition.

Conclusions:

  • Considerable variation in outcome measures and definitions exists in PIC nutrition trials.
  • There is a need to establish consensus on optimal nutrition outcomes, including nutrition efficiency, tolerance, and relevant non-nutrition PIC outcomes.
  • The next step involves an international Delphi study to develop a core outcome set for future pediatric nutrition trials.
Abstract

Related Concept Videos

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...
186
Parentral Nutrition: Centeral and Peripheral Parental Nutrition01:27

Parentral Nutrition: Centeral and Peripheral Parental Nutrition

Parenteral Nutrition (PN) delivers essential nutrients directly into the bloodstream, bypassing the digestive system. It is commonly used for individuals with severe digestive disorders or conditions that prevent normal nutrient absorption.
PN can be administered through two primary routes:
1. Central Parenteral Nutrition (CPN):
CPN involves delivering a high concentration of nutrients through a large vein. This is typically achieved using a Peripherally Inserted Central Catheter (PICC) or,...
625
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,...
94
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...
147
Inflammatory Bowel Disease III: Diagnostic Studies and Management I-Nutritional Therapy01:30

Inflammatory Bowel Disease III: Diagnostic Studies and Management I-Nutritional Therapy

Various diagnostic tests are employed in the diagnostic process for Inflammatory Bowel Disease (IBD), particularly to differentiate between Crohn's disease and ulcerative colitis.
Diagnostic studies
A colonoscopy is the definitive screening test, distinguishing ulcerative colitis from other colon diseases with similar symptoms. During a colonoscopy test, inflamed mucosa with exudate ulcerations can be observed, and biopsies are taken to determine the histologic characteristics of the...
565
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