Pediatric International Nutrition Study 2018

NCT03223038 | Completed

• 1 other identifier: P00025098
• Study Type: observational
• Target: 1,944
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Critical Illness

Keywords

Nutrition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• ventilator-free days

  28 days

• hospital length of stay

  60 days

• PICU length of stay

  60 days

• weight status

  10 days

• growth status

  10 days

Interventions

No intervention OTHER

No intervention - exposure is mechanical ventilation in PICU

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• 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.

  PMID: 27856012 BACKGROUND

• 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. No abstract available.

  PMID: 28291114 BACKGROUND

• 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. doi: 10.1097/PCC.0000000000000915.

  PMID: 27509362 BACKGROUND

• 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.

  PMID: 26985636 BACKGROUND

• 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.

  PMID: 25971721 BACKGROUND

• 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.

  PMID: 24740498 BACKGROUND

• 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.

  PMID: 22564954 BACKGROUND

• Bechard LJ, Staffa SJ, Zurakowski D, Mehta NM. Time to achieve delivery of nutrition targets is associated with clinical outcomes in critically ill children. Am J Clin Nutr. 2021 Nov 8;114(5):1859-1867. doi: 10.1093/ajcn/nqab244.

  PMID: 34320161 DERIVED

Related Links

• Pediatric Critical Care Nutrition website

Study Officials

• Nilesh M Mehta, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 19, 2017
• Study Start: January 10, 2018
• Primary Completion: March 31, 2019
• Study Completion: April 10, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)