Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children

NCT01081587 | Completed DMC

• 1 other identifier: 2008.522/23
• Study Type: interventional
• Target: 1,457
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  At least 2 days depending on the hospitalisation time

Secondary Outcomes (4)

• Incidence of complications

  At least 2 days depending on the hospitalisation time

• Nutritional status evolution

  At least 2 days depending on the hospitalisation time

• Mean length and cost of stay

  At least 2 days depending on the hospitalisation time

• Appropriate call-in Nutritional Support Team

  At least 2 days depending on the hospitalisation time

Study Arms (2)

Nutritional Support Team

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Access to a Computerized Clinical Decision Support System (CCDDS) 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.

Nutritional Support Team; Usual care

Education of Healthcare workers 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.

Nutritional Support Team

Local assistance by a dietician 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.

Nutritional Support Team

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69677, France

Location

Related Publications (2)

• 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.

  PMID: 23517767 RESULT

• 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.

  PMID: 25649237 RESULT

MeSH Terms

Conditions

Nutrition Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Noël PERETTI, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: March 5, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)