Nutrition DisordersPREDIRENCT01081587
Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children
A study testing Access to a Computerized Clinical Decision Support System (CCDDS), Education of Healthcare workers and Local assistance by a dietician in people with Nutrition Disorders, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- Access to a Computerized Clinical Decision Support System (CCDDS), Education of Healthcare workers and Local assistance by a dietician
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,457 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon (HCL) - Hôpital Femme-Mère-Enfant
Bron, 69677
About this study
Official title: Developing an Organization to Improve the Screening and Care of Starved Children in Hospital
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
- Being tested
- Access to a Computerized Clinical Decision Support System (CCDDS), Education of Healthcare workers, Local assistance by a dietician
- 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
- Medical subject headings
- Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to a Computerized Clinical Decision Support System (CCDDS)Procedure or surgery
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 workersBehavioural
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 dieticianOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Support Team | Experimental | Not described Receives: 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 | Not described Receives: Procedure: Access to a Computerized Clinical Decision Support System (CCDDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring)
Measured: At least 2 days depending on the hospitalisation time
Secondary outcomes (4)
Incidence of complications
Measured: At least 2 days depending on the hospitalisation time
Nutritional status evolution
Measured: At least 2 days depending on the hospitalisation time
Mean length and cost of stay
Measured: At least 2 days depending on the hospitalisation time
Appropriate call-in Nutritional Support Team
Measured: At least 2 days depending on the hospitalisation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noël PERETTI, MD, PhD, Principal investigator, Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant (Bron, France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081587
- Sponsor's protocol ID
- 2008.522/23
- Acronym
- PREDIRE
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2010
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23517767Duclos 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.
PubMed 25649237Abbas F, Vacheron CH, Duclos A, Touzet S, Restier L, Duclaux-Loras R, Restier L, Marotte S, Sierra A, Eid B, Duclaux IL, Poinsot P, Peretti N. Prevention of refeeding syndrome: Evaluation of an enteral refeeding protocol for severely undernourished children. J Pediatr Gastroenterol Nutr. 2025 Apr;80(4):695-704. doi: 10.1002/jpn3.12466. Epub 2025 Jan 28.
PubMed 39871710
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Organization to Improve the Screening and Care of Starved Children in Hospital
- ClinicalTrials.gov ID
- NCT01081587
- Acronym / sponsor ID
- PREDIRE / 2008.522/23
- Conditions
- Nutrition Disorders
- Keywords
- Non MeSH terms:, Children, Malnutrition, Computer Clinical Decision Support System, Cluster randomized trial, Healthcare workers, Guideline adherence, Patient safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,457 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Nutritional Support Team, Usual care |
| Education of Healthcare workersEducation 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. | Behavioural | Nutritional Support Team |
| Local assistance by a dieticianAssistance 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. | Other | Nutritional Support Team |
Primary outcome
Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring)
Time frame: At least 2 days depending on the hospitalisation time
4 secondary outcomes
Incidence of complications
Time frame: At least 2 days depending on the hospitalisation time
Nutritional status evolution
Time frame: At least 2 days depending on the hospitalisation time
Mean length and cost of stay
Time frame: At least 2 days depending on the hospitalisation time
Appropriate call-in Nutritional Support Team
Time frame: At least 2 days depending on the hospitalisation time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 23517767Touzet 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.
- Results publication: PubMed 25649237Duclos 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.
- Derived from this study: PubMed 39871710Abbas F, Vacheron CH, Duclos A, Touzet S, Restier L, Duclaux-Loras R, Restier L, Marotte S, Sierra A, Eid B, Duclaux IL, Poinsot P, Peretti N. Prevention of refeeding syndrome: Evaluation of an enteral refeeding protocol for severely undernourished children. J Pediatr Gastroenterol Nutr. 2025 Apr;80(4):695-704. doi: 10.1002/jpn3.12466. Epub 2025 Jan 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noël PERETTI, MD, PhD principal investigator
Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant (Bron, France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to a Computerized Clinical Decision Support System (CCDDS), Education of Healthcare workers and Local assistance by a dietician in people with Nutrition Disorders, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to recommended practices (including weigh in, physiotherapy, nutrition survey and monitoring) (time frame: At least 2 days depending on the hospitalisation time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01081587, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.