Nutrition Support During Pediatric Critical Illness - 2nd Multicenter, International Cohort Study
Condition: Nutrition
MeSH terms: Critical Illness
Study type: Observational

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.
    

Detailed description: 
      Nutrition Support can prevent complications associated with malnutrition and when used
      appropriately has a positive influence on clinically important outcomes, such as length of
      stay, morbidity and mortality. Making decisions regarding the most effective and safe
      nutrition support can be challenging, and consequently considerable variation exists in
      nutrition support practices in PICUs.

      This is a multicenter prospective cohort study of nutritional practices in mechanically
      ventilated children from a representative sample of medium to large (at least 8 ICU beds)
      PICUs in North America and participating centers across other countries. The investigators
      will invite centers in all 9 US Census regions, at least 3 Canadian Provinces and PICUs with
      8 or more beds from across the world. Participating sites will be recruited through the
      PALISI network (of more than 66 PICUs), by disseminating study information through national
      nutrition (e.g. ASPEN) and critical care societies (e.g. (SCCM), and e-mailing individual
      healthcare providers.

      Patient selection criteria: All children (ages 1month to 18 years) admitted to the PICU, who
      require mechanical ventilatory support with anticipated duration of stay longer than 48 hours
      will be eligible for data collection. Data collection for each eligible patient will be
      continued for a total of 10 days or until discharge from the PICU (if earlier) until a
      minimum of 15 patients (maximum 40 patients) are accrued per site. The investigators
      anticipate recruitment of 500 patients.

      The trained dietitians (or a designated research nurse) at participating centers will use a
      validated web-based remote data capture tool to record details of nutritional intake. An
      instruction package describing data collection methods in detail will be provided. Following
      a training period, beginning on the 'going live' date, the dietitian or designated
      coordinator at participating centers will simultaneously enter relevant data online using a
      secure website.

      Nutritional variables including the energy and protein goals prescribed by the local
      nutrition team, actual daily macronutrient delivery achieved, route of delivery, frequency
      and duration of feeding interruptions, and use of adjunctive drugs, will be recorded.
      Prescribed protein goals for each subject will be compared to the recommended daily protein
      in the 2005 DRI and the 2009 A.S.P.E.N. age-based guidelines. The end point for nutritional
      data collection is 10 days or discharge from the PICU, whichever was sooner. The energy and
      protein intake adequacy will be calculated as the percentage of the prescribed goal that was
      actually delivered and an average adequacy over the PICU stay up to 10 days was derived.

      The primary outcome for this study is 60-day patient mortality.
    

Intervention name(s): NO INTERVENTIONS
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Protein; Mechanical ventilation; Children; Outcomes