Clinical Trials Directory

Trials / Completed

CompletedNCT03223038

Pediatric International Nutrition Study 2018

Pediatric International Nutrition Study - a Prospective, Multicenter Cohort Study of Nutritional Practices and Outcomes in Pediatric Intensive Care Units Around the World

Status
Completed
Phase
Study type
Observational
Enrollment
1,944 (actual)
Sponsor
Boston Children's Hospital · Academic / Other
Sex
All
Age
1 Month – 18 Years
Healthy volunteers
Not accepted

Summary

This is a multi-site study of how nutrition is delivered to critically ill patients in pediatric intensive care units (PICUs) around the world. Each site will include mechanically ventilated children in their respective PICUs and record the details of what type and amount of nutrition was received. These details will be compared to goals designated by the clinicians caring for each patient. Data will be entered in a secure online remote data capture tool and managed by the lead researchers in Pediatric Critical Care Nutrition at Boston Children's Hospital, Nilesh Mehta, MD and Lori Bechard, PhD, RD. Data will be analyzed to better understand how different types and amounts of nutrition impact important PICU outcomes such as length of stay, ventilator time, incidence of infections, and mortality.

Detailed description

Specific aim 1: To examine the impact of energy and protein adequacy on clinical outcomes. Specific aim 2: To describe world-wide patterns of nutritional therapies in the PICU.environment: use of guidelines/use of adjuncts (acid suppression, motility, etc.)/glycemic control strategy/etc. To describe these practices in subgroups of: cardiac, surgical, medical, oncology/stem cell transplant patients in the PICU. Specific aim 3: To examine enteral nutrition practices, including timing, route (gastric vs. post pyloric), adjuncts, and enteral nutrition (EN) intolerance definitions, in PICU patients worldwide Specific aim 4: To examine the current practices around parenteral nutrition prescription during the first week of critical illness in the PICU; time of initiation (early vs. late), rationale, threshold for initiation. Primary predictor: nutritional adequacy (energy, protein) Secondary predictors: nutritional status, use of guidelines/site level indicators (location, staffing), use of adjuncts (acid suppression, motility, etc.), EN intolerance, subgroups (cardiac, surgical, medical, oncology/stem cell transplant), EN route/timing

Conditions

Interventions

TypeNameDescription
OTHERNo interventionNo intervention - exposure is mechanical ventilation in PICU

Timeline

Start date
2018-01-10
Primary completion
2019-03-31
Completion
2019-04-10
First posted
2017-07-19
Last updated
2019-04-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03223038. Inclusion in this directory is not an endorsement.