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Pediatric Critical IllnessPINS 2018NCT03223038

Pediatric International Nutrition Study 2018

An observational study of Pediatric Critical Illness, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
Pediatric Critical Illness
How many people
1,944 participants
Where
1 siteUnited States
Study dates
10 Jan 2018to 10 Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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

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.

Read the 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

Being tested
No intervention
Keywords
Nutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention - exposure is mechanical ventilation in PICU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 60 day mortality

    incidence of mortality over 60 days following admission to PICU

    Measured: 60 days

  2. incidence of hospital acquired infections

    the number of infections (urinary tract, ventilator-associated, respiratory, or surgical site) that are acquired following PICU admission

    Measured: 60 days

Secondary outcomes (8)

  1. ventilator-free days

    the number of days not requiring ventilator support during hospitalization

    Measured: 28 days

  2. hospital length of stay

    the number of days patient remains in the hospital following admission to the PICU

    Measured: 60 days

  3. PICU length of stay

    the number of days patient remains in the PICU following admission

    Measured: 60 days

  4. weight status

    weight-for-age Z-scores as determined by WHO standard growth criteria

    Measured: 10 days

  5. growth status

    height-for-age Z-scores as determined by WHO standard growth criteria

    Measured: 10 days

  6. nutritional status

    BMI or weight-for-height Z-scores as determined by WHO standard growth criteria

    Measured: 10 days

  7. body composition in subgroup

    % fat mass and % lean mass as assessed by bioelectrical impedance spectroscopy in approved subgroup

    Measured: 10 days

  8. glycemic control

    evaluation of clinically obtained maximum and minimum blood glucose values and use of insulin

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2017
  2. Study start10 Jan 2018
  3. Primary completion31 Mar 2019
  4. Study completion10 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,944 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03223038
Sponsor's protocol ID
P00025098
Acronym
PINS 2018
Status last verified
Apr 2019
First submitted
18 Jul 2017
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27856012

  • 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.

    PubMed 28291114

  • 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.

    PubMed 27509362

  • 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.

    PubMed 26985636

  • 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.

    PubMed 25971721

  • 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.

    PubMed 24740498

  • 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.

    PubMed 22564954

  • Akhondi-Asl A, Ariagno K, Fluckiger L, Chaparro CJ, Martinez EE, Moreno YMF, Ong C, Skillman HE, Tume L, Mehta NM, Bechard LJ. Changes in Global Nutrition Practices in Critically Ill Children and the Influence of Emerging Evidence: A Secondary Analysis of the Pediatric International Nutrition Studies, 2009-2018. J Acad Nutr Diet. 2024 Dec;124(12):1657-1667.e5. doi: 10.1016/j.jand.2024.04.014. Epub 2024 Apr 26.

    PubMed 38679383

  • 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.

    PubMed 34320161

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Critical Illness, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

60 day mortality (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03223038, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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