Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children (PREDIRE)

December 13, 2025 updated by: Hospices Civils de Lyon

Developing an Organization to Improve the Screening and Care of Starved Children in Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1457

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Procedure: Access 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.
Experimental: Nutritional Support Team
Procedure: Access 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.
Behavioral: Education 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.
Other: Local 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring)
Time Frame: At least 2 days depending on the hospitalisation time
At least 2 days depending on the hospitalisation time

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of complications
Time Frame: At least 2 days depending on the hospitalisation time
At least 2 days depending on the hospitalisation time
Nutritional status evolution
Time Frame: At least 2 days depending on the hospitalisation time
At least 2 days depending on the hospitalisation time
Mean length and cost of stay
Time Frame: At least 2 days depending on the hospitalisation time
At least 2 days depending on the hospitalisation time
Appropriate call-in Nutritional Support Team
Time Frame: At least 2 days depending on the hospitalisation time
At least 2 days depending on the hospitalisation time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Noël PERETTI, MD, PhD, Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant (Bron, France)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (Estimated)

March 5, 2010

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.522/23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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