Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children

NCT ID: NCT01081587

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nutrition Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nutritional Support Team

Group Type EXPERIMENTAL

Access to a Computerized Clinical Decision Support System (CCDDS)

Intervention Type PROCEDURE

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

Education of Healthcare workers

Intervention Type BEHAVIORAL

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.

Local assistance by a dietician

Intervention Type OTHER

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.

Usual care

Group Type ACTIVE_COMPARATOR

Access to a Computerized Clinical Decision Support System (CCDDS)

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Noël PERETTI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant

Bron, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23517767 (View on PubMed)

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.

Reference Type RESULT
PMID: 25649237 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008.522/23

Identifier Type: -

Identifier Source: org_study_id