Pediatric International Nutrition Study 2018

Pediatric Critical Illness Clinical Trial

— PINS 2018  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223038
• Other study ID #: P00025098
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: April 10, 2019

Study information

• Verified date: April 2019
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1944
• Est. completion date: April 10, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Pediatric Critical Illness

Intervention

Other:
• No intervention
No intervention - exposure is mechanical ventilation in PICU

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

Albert BD, Zurakowski D, Bechard LJ, Priebe GP, Duggan CP, Heyland DK, Mehta NM. Enteral Nutrition and Acid-Suppressive Therapy in the PICU: Impact on the Risk of Ventilator-Associated Pneumonia. Pediatr Crit Care Med. 2016 Oct;17(10):924-929. — View Citation

Bechard LJ, Duggan C, Touger-Decker R, Parrott JS, Rothpletz-Puglia P, Byham-Gray L, Heyland D, Mehta NM. Nutritional Status Based on Body Mass Index Is Associated With Morbidity and Mortality in Mechanically Ventilated Critically Ill Children in the PICU. Crit Care Med. 2016 Aug;44(8):1530-7. doi: 10.1097/CCM.0000000000001713. — View Citation

Bechard LJ, Mehta NM. Nutritional Assessment Must be Prioritized for Critically Ill Children in the PICU. Crit Care Med. 2017 Apr;45(4):e464. doi: 10.1097/CCM.0000000000002220. — View Citation

Martinez EE, Bechard LJ, Mehta NM. Nutrition algorithms and bedside nutrient delivery practices in pediatric intensive care units: an international multicenter cohort study. Nutr Clin Pract. 2014 Jun;29(3):360-7. doi: 10.1177/0884533614530762. Epub 2014 Apr 16. — View Citation

Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8. — View Citation

Mehta NM, Bechard LJ, Zurakowski D, Duggan CP, Heyland DK. Adequate enteral protein intake is inversely associated with 60-d mortality in critically ill children: a multicenter, prospective, cohort study. Am J Clin Nutr. 2015 Jul;102(1):199-206. doi: 10.3945/ajcn.114.104893. Epub 2015 May 13. — View Citation

Velazco CS, Zurakowski D, Fullerton BS, Bechard LJ, Jaksic T, Mehta NM. Nutrient delivery in mechanically ventilated surgical patients in the pediatric critical care unit. J Pediatr Surg. 2017 Jan;52(1):145-148. doi: 10.1016/j.jpedsurg.2016.10.041. Epub 2016 Oct 28. — View Citation

Outcome

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

External Links

•   Pediatric Critical Care Nutrition website