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NCT Number: NCT03223038

Pediatric International Nutrition Study 2018

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.

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Key information

Conditions

Pediatric Critical Illness

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention - exposure is mechanical ventilation in PICU

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Acronym: PINS 2018

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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