NutritionPINS2NCT02354521
Nutrition Support During Pediatric Critical Illness - 2nd Multicenter, International Cohort Study
An observational study of Nutrition, run by Boston Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Nutrition
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jul 2014
- 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: Children (age 1 month to 18 yrs) admitted to the PICU with anticipated stay longer than 48 hours, and who require mechanical ventilatory support.
Who may be able to join
- Age 1 month to 18 yrs
- PICU anticipated stay longer than 48 hours, on mechanical ventilatory support
Who cannot join
- 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
About this study
Official title: NUTRITION SUPPORT DURING PEDIATRIC CRITICAL ILLNESS - 2ND MULTICENTER, INTERNATIONAL COHORT STUDY OF BARRIERS AND OUTCOMES
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.
Read the 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.
- Conditions
- Nutrition
- Being tested
- NO INTERVENTIONS
- Keywords
- Protein, Mechanical ventilation, Children, Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO INTERVENTIONSOther
What is being measured
The primary outcome is the main question the study is designed to answer.
60-day mortality
Measured: 60 days
Secondary outcomes (2)
Acquired infections
Acquired infections include ventilator associated pneumonia, urinary tract infection and catheter associated blood stream infection during the PICU stay.
Measured: PICU stay
Ventilator free days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilesh M. Mehta, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354521
- Sponsor's protocol ID
- X-10 11 0569
- Acronym
- PINS2
- Status last verified
- Jan 2015
- First submitted
- 29 Jan 2015
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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 22564954Mehta 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRITION SUPPORT DURING PEDIATRIC CRITICAL ILLNESS - 2ND MULTICENTER, INTERNATIONAL COHORT STUDY OF BARRIERS AND OUTCOMES
- ClinicalTrials.gov ID
- NCT02354521
- Acronym / sponsor ID
- PINS2 / X-10 11 0569
- Conditions
- Nutrition
- Keywords
- Protein, Mechanical ventilation, Children, Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Age 1 month to 18 yrs
- PICU anticipated stay longer than 48 hours, on mechanical ventilatory support
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO INTERVENTIONS | Other | – |
Primary outcome
60-day mortality
Time frame: 60 days
2 secondary outcomes
Acquired infections
Time frame: PICU stay
Ventilator free days
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Background: PubMed 22564954Mehta 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.
- Derived from this study: PubMed 25971721Mehta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition, run by Boston Children's Hospital.
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 3 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 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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). 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 NCT02354521, which also lists 2 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 3 Feb 2015.