Nutrition Support During Pediatric Critical Illness - 2nd Multicenter, International Cohort Study

NCT02354521 | Completed

• 1 other identifier: X-10 11 0569
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

An observational, point-prevalence cohort study of nutrition therapies in critically ill children in PICUs across the world. Baseline information will be collected including PICU and hospital demographics and characteristics (e.g. age, diagnostic category, PRISM score, weight, height) of critically ill children requiring mechanical ventilation in the PICU. Nutrition practices such as route of nutrition, kilocalorie and protein levels prescribed and received, interruptions, etc., will be collected on a daily basis from PICU admission onwards, for a maximum of 10 days. Data on clinical outcomes (e.g. duration of mechanical ventilation, PICU stay, hospital stay, acquired infections) will be collected up to 60 days after admission to the PICU. The main objective of the study is to examine the association between energy and protein intake adequacy (in relation to the prescribed goals for these nutrients) and 60-day mortality in mechanically ventilated children.

Conditions

Nutrition

Keywords

Protein; Mechanical ventilation; Children; Outcomes

Outcome Measures

Primary Outcomes (1)

• 60-day mortality

  60 days

Secondary Outcomes (2)

• Acquired infections

  PICU stay

• Ventilator free days

  28 days

Interventions

NO INTERVENTIONS OTHER

Eligibility Criteria

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

Study Population

Children (age 1 month to 18 yrs) admitted to the PICU with anticipated stay longer than 48 hours, and who require mechanical ventilatory support.

You may qualify if:

• Age 1 month to 18 yrs
• PICU anticipated stay longer than 48 hours, on mechanical ventilatory support

You may not qualify if:

• Patients who were not ventilated within the first 48 hours of admission to PICU
• On compassionate care toward end-of-life
• Those enrolled in any other nutritional intervention trial will be excluded

Sponsors & Collaborators

• Boston Children's Hospital: lead

Related Publications (2)

• 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

• 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 DERIVED

Study Design

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

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: August 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: February 3, 2015

Record last verified: 2015-01