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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03223038
Acronym
PINS 2018
Enrollment
1944
Registered
2017-07-19
Start date
2018-01-10
Completion date
2019-04-10
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Critical Illness

Keywords

Nutrition

Brief 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

Interventions

OTHERNo intervention

No intervention - exposure is mechanical ventilation in PICU

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* Sites with at least 8 PICU beds with the capacity to designate a site-specific clinician for data collection, preferably a clinician with an interest in nutrition or a dietitian, are eligible to participate. * Patients 1 month to 18 years of age, admitted to the PICU and requiring mechanical ventilation with an anticipated length of PICU stay of 3 days or more.

Exclusion criteria

* Sites with \< 8 PICU beds and/or no available clinician for data collection * Subjects \< 1 month or \> 18 years, PICU length of stay \< 3 days, not mechanically ventilated, receiving compassionate care only towards end of life, or enrolled in a nutrition intervention trial

Design outcomes

Primary

MeasureTime frameDescription
60 day mortality60 daysincidence of mortality over 60 days following admission to PICU
incidence of hospital acquired infections60 daysthe number of infections (urinary tract, ventilator-associated, respiratory, or surgical site) that are acquired following PICU admission

Secondary

MeasureTime frameDescription
hospital length of stay60 daysthe number of days patient remains in the hospital following admission to the PICU
weight status10 daysweight-for-age Z-scores as determined by WHO standard growth criteria
growth status10 daysheight-for-age Z-scores as determined by WHO standard growth criteria
PICU length of stay60 daysthe number of days patient remains in the PICU following admission
body composition in subgroup10 days% fat mass and % lean mass as assessed by bioelectrical impedance spectroscopy in approved subgroup
glycemic control10 daysevaluation of clinically obtained maximum and minimum blood glucose values and use of insulin
nutritional status10 daysBMI or weight-for-height Z-scores as determined by WHO standard growth criteria
ventilator-free days28 daysthe number of days not requiring ventilator support during hospitalization

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026