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Malnutrition, ChildP-INPACNCT06645639

Implementation of P-INPAC

An observational study of Malnutrition, Child and Nutrition Poor, run by The Hospital for Sick Children at 3 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The framework for Pediatric Integrated Nutrition Pathway for Acute Care (P-INPAC) was developed by the Canadian Malnutrition Task Force (CMTF); however, it has not been implemented in a research setting. Read more about this study

Who is it for?
Ages 30 days to 18 yearsHealthy volunteers can take part
Conditions the study is for
Malnutrition, Child, Nutrition Poor
What is being tested?
Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC)
How many people
600 participants
Where
3 sitesCanada
Study dates
4 Sep 2023to 30 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 30 days to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: 2 Patient Groups (Audit and Detailed) 1 Health care providers group comprising of all the healthcare providers on the participating wards.

Who may be able to join

None listed.

Who cannot join

  • Patients with eating disorder, somatization disorders, ARFID, FORM 1 etc. where the study interaction might interfere with the messaging or therapeutic plan as set out by the responsible team.
  • Phase 1 and 3 for Health Care Providers inclusion criteria:
  • Implied consent to participate by completing the KAP questionnaire
  • Providing clinical service for the select ward

Trial locations and contacts

3 sites in 1 country.

Canada3 sites
  • McMaster Children's Hospital

    Hamilton, Ontario, L8N 3Z5

  • Ste-Justine UHC

    Montreal, Quebec, H3T 1C5

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: Towards Implementation of the Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC) - Pilot Study

The framework for Pediatric Integrated Nutrition Pathway for Acute Care (P-INPAC) was developed by the Canadian Malnutrition Task Force (CMTF); however, it has not been implemented in a research setting. The framework by CMTF for Integrated Nutrition Pathway for Acute Care (INPAC) in adults was also implemented in the "More-2-Eat" project which led to development of best practices in nutritional culture of the hospitals. Therefore, we intend to undertake this feasibility project at 3-sites to train staff and evaluate the implementation of P-INPAC components as part of routine healthcare procedure.

Read the detailed description

The P-INPAC pilot study will be a 3-phase multi-center research study in hospitalized children, conducted at The Hospital for Sick Children, Toronto, and two other Canadian pediatric centres: Centre hospitalier universitaire Sainte-Justine, Montreal, Quebec and McMaster Children's Hospital, Hamilton, Ontario. P-INPAC is an algorithm which helps to identify, assess, and treat children with malnutrition.

In the first phase of the study, we will perform an audit of health records of all hospitalized patients at one selected study ward, one day of every other week for 8 weeks, at each of the 3 study sites to track their routine nutrition care. We anticipate auditing 80-100 patients/site in this cycle (total 240-300 patients). In addition, ≈12- 20 patients/ site (≈ 60 in total) who consent to detailed malnutrition screening and assessment would also be identified, assessed, and followed up one month after discharge. In addition, a questionnaire assessing the malnutrition knowledge, attitude, and self-perceived practices (KAP) amongst healthcare professionals will be conducted with staff, including trainees, at each site's study ward. Further, the workload of the study ward's Registered Dietitian (RD) will be assessed for 3 days.

In the second phase of the study, the health care team from each site's study ward will be trained by the site implementation research team about the P-INPAC, and how to administer nutritional screening and perform nutritional assessments, which is the Subjective Global Nutrition Assessment (SGNA).

Finally, in the third phase, we will monitor and evaluate the implementation of the first 2 steps of the P-INPAC (screening \& assessment) over a period of 4 months assessing the acceptability, adoption, and coverage of improved nutrition care practices on the same pediatric study wards. We anticipate auditing 160-200 patients/site in this cycle (total 480-600 patients). In addition, detailed patient level data collection will take place in a selected group of consented patients, ≈24-40 patients per site from the 3 sites (≈120 in total). We would also follow-up with these patients a month after discharge.

Healthcare providers will be invited to answer the KAP questionnaire post-implementation version. We will compare responses from phase 1 with phase 3 (pre-/ post-follow up). And, the workload of the ward RD will be assessed again over 3 days.

Being tested
Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC)
Medical subject headings
Child Nutrition Disorders, Malnutrition

What participants receive

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

  • Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC)Other

    The pediatric working group of Canadian Malnutrition Task Force has developed an evidence-informed algorithm named the Pediatric Integrated Nutrition Pathway for Acute Care (P-INPAC). The P-INPAC outlines a process to improve nutrition care by:

    1. implementing nutrition screening at point-of-admission
    2. introducing standard care measures to prevent the development of malnutrition in children admitted with normal nutrition status, including standardizing the process of monitoring food intake early and systematically to identify when standard care measures are not sufficient
    3. ensuring the moderately and severely malnourished patients receive timely specialized care in the form of a comprehensive assessment and treatment; and
    4. ensuring moderately and severely malnourished patients receive adequate post discharge follow-up and nutrition care.

    In this pilot study, we will be implementing the first two steps of P-INPAC only (screening and assessment).

Study groups in NCT06645639
Study groupRoleWhat they receive
Audit GroupWe will perform an audit of health records of all hospitalized patients at one selected study ward, one day of every other week, at each of the 3 study sites to track their routine nutrition care in phase 1 and changes in nutrition care post-implementation in phase 3.
Receives: Other: Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC)
Detailed Patient GroupPatients will be recruited in this group from one selected study ward, one day of every other week, at each of the 3 study sites to track their routine nutrition care in phase 1 and changes in nutrition care post-implementation in phase 3. They will also be followed up over a phone call one month after discharge.
Receives: Other: Pediatric Integrated Nutrition Pathway for Acute Care Pathway (P-INPAC)
Healthcare Provider GroupA questionnaire assessing the knowledge, attitude, and self-perceived practices (KAP) amongst healthcare professionals will be conducted with staff, including trainees, at each site's study ward. Further, the workload of the study ward's Registered Dietitian will be assessed for 3 days.

What is being measured

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

  1. Baseline nutrition risk screening using STRONGkids or PNST

    Determine routine standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 1 of study using a validated tool, such as, STRONGkids or PNST.

    Measured: 2-month period (phase 1)

  2. Baseline nutrition risk screening using weight

    Determine routine standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 1 of study using routine anthropometrics - weight

    Measured: 2-month period (phase 1)

  3. Baseline nutrition risk screening using height or length

    Determine routine standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 1 of study using routine anthropometrics - height or length in children under 2 years of age

    Measured: 2-month period (phase 1)

  4. Baseline nutrition risk screening using head circumference

    Determine routine standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 1 of study using routine anthropometrics - head circumference in children under 2 years of age

    Measured: 2-month period (phase 1)

  5. Determine baseline knowledge among healthcare providers using the KAP questionnaire

    Determine baseline knowledge among healthcare providers on recognizing malnutrition and its management in hospitalized children, including perceived barriers and practices, using the KAP questionnaire

    Measured: 2-month period (phase 1)

  6. Determine changes in knowledge among healthcare providers using the KAP questionnaire

    Determine changes in knowledge among healthcare providers on recognizing malnutrition and its management in hospitalized children in Phase 3, including perceived barriers and practices, using the KAP questionnaire after training was completed in phase 2

    Measured: 4-month period (phase 3)

  7. Determine success with training and feasibility of nutrition risk screening in hospitalized children using STRONGkids and PNST

    Determine success with training and feasibility of implementing the P-INPAC framework by assessing changes in standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 3 of study using a validated tool, such as, STRONGkids and PNST

    Measured: 4-month period (phase 3)

  8. Determine success with training and feasibility of nutrition risk screening in hospitalized children using weight

    Determine success with training and feasibility of implementing the P-INPAC framework by assessing changes in standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 3 of study using routine anthropometrics - weight

    Measured: 4-month period (phase 3)

  9. Determine success with training and feasibility of nutrition risk screening in hospitalized children using height/ length

    Determine success with training and feasibility of implementing the P-INPAC framework by assessing changes in standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 3 of study using routine anthropometrics - height or length in children under 2 years of age

    Measured: 4-month period (phase 3)

  10. Determine success with training and feasibility of nutrition risk screening in hospitalized children using head circumference

    Determine success with training and feasibility of implementing the P-INPAC framework by assessing changes in standard nutritional care practices related to nutrition risk screening in hospitalized children during phase 3 of study using routine anthropometrics - head circumference in children under 2 years of age

    Measured: 4-month period (phase 3)

Timeline

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

  1. First posted17 Oct 2024
  2. Study start4 Sep 2023
  3. Primary completion30 Sep 2025
  4. Study completion30 Dec 2026 (estimated)

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
Other
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06645639
Sponsor's protocol ID
1000079853
Acronym
P-INPAC
Status last verified
Jun 2026
First submitted
24 Jul 2024
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data entered the REDCap data collection form will be completely confidential and de-identified and can only be rendered identifiable by linking the study IDs in the data collection form to the study IDs encrypted master linking log. The master linking log will be maintained by the site and not shared by the other site. Confidentiality will be respected and no information that discloses the identity of the participants will be released or published. The data will be kept stored for a minimum of 7 years following collection of the study in accordance with SickKids data retention policy, or longer as per study site institutional research ethics board requirements.

Publications

  • Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.

    PubMed 19682776
  • Secker DJ, Jeejeebhoy KN. How to perform Subjective Global Nutritional assessment in children. J Acad Nutr Diet. 2012 Mar;112(3):424-431.e6. doi: 10.1016/j.jada.2011.08.039. Epub 2012 Mar 1.

    PubMed 22717202
  • Huysentruyt K, Brunet-Wood K, Bandsma R, Gramlich L, Fleming-Carroll B, Hotson B, Byers R, Lovelace H, Persad R, Kalnins D, Martinez A, Marchand V, Vachon M, Hulst JM, On Behalf Of The Canadian Malnutrition Task Force-Pediatric Working Group. Canadian Nationwide Survey on Pediatric Malnutrition Management in Tertiary Hospitals. Nutrients. 2021 Jul 30;13(8):2635. doi: 10.3390/nu13082635.

    PubMed 34444796
  • Keller H, Laur C, Atkins M, Bernier P, Butterworth D, Davidson B, Hotson B, Nasser R, Laporte M, Marcell C, Ray S, Bell J. Update on the Integrated Nutrition Pathway for Acute Care (INPAC): post implementation tailoring and toolkit to support practice improvements. Nutr J. 2018 Jan 5;17(1):2. doi: 10.1186/s12937-017-0310-1.

    PubMed 29304866

Questions about this trial

What is this clinical trial studying?

An observational study of Malnutrition, Child and Nutrition Poor, run by The Hospital for Sick Children at 3 sites in Canada.

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 0 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. 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?

This study is still under way. Results are not available in the source record yet.

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?

Baseline nutrition risk screening using STRONGkids or PNST (time frame: 2-month period (phase 1)). The study lists 10 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 NCT06645639, which also lists 4 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 24 Jun 2026.

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