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Completed

NCT Number: NCT01081587

Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children

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.

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Key information

Conditions

Nutrition Disorders Malnutrition Nutritional and Metabolic Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bron, 69677, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PREDIRE

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 5, 2010
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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