CClinicalTrials.gg
CompletedNCT01081587PREDIREUpdated Dec 19, 2025

Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children

An interventional study of Access to a Computerized Clinical Decision Support System (CCDDS) and Education of Healthcare workers in Nutrition Disorders, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,457
Allocation
Randomized
Ages
1 Month to 18 Years
Sex
All
01

Study summary

This cluster-randomized trial will evaluate the impact of a multifaceted intervention (including electronic medical alerts) coordinated by a Nutritional Support Team, on adherence to recommended practices for care of starved children, among health personnel of a large university hospital. A key component of the study is to assess whether improved adherence to guidelines leads to a reduction in rates of complications.

02

Conditions studied

  • Nutrition Disorders

Keywords

  • Non MeSH terms:
  • Children
  • Malnutrition
  • Computer Clinical Decision Support System
  • Cluster randomized trial
  • Healthcare workers
  • Guideline adherence
  • Patient safety
  • MeSH terms:
  • Nutrition Surveys
  • Secondary Prevention
  • Pediatrics
  • Child Care
  • Health Personnel
  • Reminder Systems
  • Intervention Studies
  • Quality of Health Care
03

In context

Nutrition Disorders

275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.

This study's enrollment of 1,457 is above the median of 117 across 194 interventional studies indexed under Nutrition Disorders.

Browse Nutrition Disorders studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • medical and surgical units in a large teaching hospital providing pediatric acute care.
  • any hospital staff with direct patient care who are affiliated with a single unit (includes physicians, nurses, nursing assistants, physiotherapists, dieticians.
  • all children recorded as malnourished at their entrance in hospital

Exclusion criteria

Exclusion Criteria:

  • neonatal and intensive care units.
  • any hospital staff with direct patient care who are not affiliated with a single unit.
  • age under one month, liver or kidney abnormalities, severe heart failure, stay less than 2 days.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,457 participants (actual)

Study arms

  • Experimental
    Nutritional Support Team

    Procedure: Access to a Computerized Clinical Decision Support System (CCDDS) · Behavioral: Education of Healthcare workers · Other: Local assistance by a dietician

  • Active comparator
    Usual care

    Procedure: Access to a Computerized Clinical Decision Support System (CCDDS)

Interventions

  • ProcedureAccess to a Computerized Clinical Decision Support System (CCDDS)

    Automatic CCDSS will alert physician for each case of malnourished using an algorithm based on age, sex, weight and size of each hospitalized children.

  • BehavioralEducation of Healthcare workers

    Education of the hospital staff to evidence-based practices in malnutrition care will be proposed in the experimental arm. Specific training will be targeted on participants according to their function.

  • OtherLocal assistance by a dietician

    Assistance will be conducted locally by a local dietician. Periodic multidisciplinary meetings will be attended by the hospital staff belonging to the intervention arm, including the analysis of clinical incidents related to nutrition care.

06

What researchers measure

Primary outcomes

  1. Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring)

    Time frame: At least 2 days depending on the hospitalisation time

Secondary outcomes

  1. Incidence of complications

    Time frame: At least 2 days depending on the hospitalisation time

  2. Nutritional status evolution

    Time frame: At least 2 days depending on the hospitalisation time

  3. Mean length and cost of stay

    Time frame: At least 2 days depending on the hospitalisation time

  4. Appropriate call-in Nutritional Support Team

    Time frame: At least 2 days depending on the hospitalisation time

07

Study locations

1 site
  • Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant
    Bron, 69677, France
08

References and documents

Publications

  • Touzet S, Duclos A, Denis A, Restier-Miron L, Occelli P, Polazzi S, Betito D, Gamba G, Cour-Andlauer F, Colin C, Lachaux A, Peretti N; PREDIRE Study Group. Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial. BMC Health Serv Res. 2013 Mar 22;13:107. doi: 10.1186/1472-6963-13-107. PubMed 23517767 ↗
  • Duclos A, Touzet S, Restier L, Occelli P, Cour-Andlauer F, Denis A, Polazzi S, Colin C, Lachaux A, Peretti N; PREDIRE Study Group. Implementation of a computerized system in pediatric wards to improve nutritional care: a cluster randomized trial. Eur J Clin Nutr. 2015 Jul;69(7):769-75. doi: 10.1038/ejcn.2014.288. Epub 2015 Feb 4. PubMed 25649237 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01081587
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Mar 5, 2010
Start date
Oct 2009
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Dec 19, 2025

Study contacts

Noël PERETTI, MD, PhD
principal investigator · Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant (Bron, France)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion