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Pediatric International Nutrition Study 2018 (PINS 2018)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223038
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Nilesh M. Mehta, Boston Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Pediatric Critical Illness Other: No intervention

Detailed 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

Study Design
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Study Type : Observational
Actual Enrollment : 1944 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric International Nutrition Study - a Prospective, Multicenter Cohort Study of Nutritional Practices and Outcomes in Pediatric Intensive Care Units Around the World
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : April 10, 2019
Groups and Cohorts
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Intervention Details:
  • Other: No intervention
    No intervention - exposure is mechanical ventilation in PICU

Outcome Measures
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Primary Outcome Measures :
  1. 60 day mortality [ Time Frame: 60 days ]
    incidence of mortality over 60 days following admission to PICU

  2. incidence of hospital acquired infections [ Time Frame: 60 days ]
    the number of infections (urinary tract, ventilator-associated, respiratory, or surgical site) that are acquired following PICU admission


Secondary Outcome Measures :
  1. ventilator-free days [ Time Frame: 28 days ]
    the number of days not requiring ventilator support during hospitalization

  2. hospital length of stay [ Time Frame: 60 days ]
    the number of days patient remains in the hospital following admission to the PICU

  3. PICU length of stay [ Time Frame: 60 days ]
    the number of days patient remains in the PICU following admission

  4. weight status [ Time Frame: 10 days ]
    weight-for-age Z-scores as determined by WHO standard growth criteria

  5. growth status [ Time Frame: 10 days ]
    height-for-age Z-scores as determined by WHO standard growth criteria

  6. nutritional status [ Time Frame: 10 days ]
    BMI or weight-for-height Z-scores as determined by WHO standard growth criteria

  7. body composition in subgroup [ Time Frame: 10 days ]
    % fat mass and % lean mass as assessed by bioelectrical impedance spectroscopy in approved subgroup

  8. glycemic control [ Time Frame: 10 days ]
    evaluation of clinically obtained maximum and minimum blood glucose values and use of insulin


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223038


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Nilesh M Mehta, MD Boston Children's Hospital
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nilesh M. Mehta, Associate Professor of Anesthesia, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03223038    
Other Study ID Numbers: P00025098
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nilesh M. Mehta, Boston Children's Hospital:
Nutrition
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes