Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children

Nutrition Disorders Clinical Trial

— PREDIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081587
• Other study ID #: 2008.522/23
• Status: Completed
• Phase: N/A
• First received: February 19, 2010
• Last updated: May 14, 2013
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: May 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1457
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nutrition Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring)		At least 2 days depending on the hospitalisation time	No
Secondary	Incidence of complications		At least 2 days depending on the hospitalisation time	Yes
Secondary	Nutritional status evolution		At least 2 days depending on the hospitalisation time	Yes
Secondary	Mean length and cost of stay		At least 2 days depending on the hospitalisation time	No
Secondary	Appropriate call-in Nutritional Support Team		At least 2 days depending on the hospitalisation time	No