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

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ClinicalTrials.gov Identifier: NCT01081587
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Nutrition Disorders Procedure: Access to a Computerized Clinical Decision Support System (CCDDS) Behavioral: Education of Healthcare workers Other: Local assistance by a dietician

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developing an Organization to Improve the Screening and Care of Starved Children in Hospital
Study Start Date : October 2009
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081587


Locations
France
Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Noël PERETTI, MD, PhD Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant (Bron, France)
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01081587     History of Changes
Other Study ID Numbers: 2008.522/23
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by Hospices Civils de Lyon:
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

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders