Pediatric International Nutrition Study 2018

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pediatric Critical Illness

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention - exposure is mechanical ventilation in PICU|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60 day mortality | incidence of mortality over 60 days following admission to PICU | 60 days | 
| incidence of hospital acquired infections | the number of infections (urinary tract, ventilator-associated, respiratory, or surgical site) that are acquired following PICU admission | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator-free days | the number of days not requiring ventilator support during hospitalization | 28 days | 
| hospital length of stay | the number of days patient remains in the hospital following admission to the PICU | 60 days | 
| PICU length of stay | the number of days patient remains in the PICU following admission | 60 days | 
| weight status | weight-for-age Z-scores as determined by WHO standard growth criteria | 10 days | 
| growth status | height-for-age Z-scores as determined by WHO standard growth criteria | 10 days | 
| nutritional status | BMI or weight-for-height Z-scores as determined by WHO standard growth criteria | 10 days | 
| body composition in subgroup | % fat mass and % lean mass as assessed by bioelectrical impedance spectroscopy in approved subgroup | 10 days | 
| glycemic control | evaluation of clinically obtained maximum and minimum blood glucose values and use of insulin | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition