Nutritional Status on Admission to Pediatric Intensive Care

Malnutrition Clinical Trial

— NUTRI-REAPED  

Official title:

Nutritional Status on Admission to Pediatric Intensive Care: A French Multicentric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293434
• Other study ID #: 9251
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: November 19, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.

As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.

Primary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.

Secondary objectives:

• Determine the children's nutritional status on admission.

• Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).

• Describe the practices regarding nutritional care in each center.

Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.

Description:

Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.

As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.

Primary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.

Secondary objectives:

• Determine the children's nutritional status on admission.

• Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).

• Describe the practices regarding nutritional care in each center.

Study design:

• Type of study: Observational, descriptive, transversal, and multicentric.

• Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.

• Primary assessment parameter: Malnutrition, as defined by the body mass index (BMI) value <-2 SD, according to the WHO Child Growth Standards.

• Factors studied:

• Nutritional status on admission based on the measurement of simple anthropometric parameters: weight (W), height (H), head circumference (HC) and mid-upper arm circumference (MUAC), which are then used to calculate malnutrition indices.

• Profile of malnourished patients in relation to hospitalization parameters (age, sex, reason for admission, history, dietary habits).

• Nutritional practices in PICUs assessed with two questionnaires (medical and nursing) sent to all participating hospitals.

• Sample size: Number of subjects needed to estimate the prevalence of malnutrition, based on the data in the literature with a confidence interval of 95%±3.2%: 600.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarf - Nutritional
• Malnutrition

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	Nutritional status (measurement of simple anthropometric parameters, which are then used to calculate malnutrition indices) on admission	Baseline	No
Secondary	Nutritional practice in PICUs	Nutritional practice in PICUs once during the study : two questionnaires (medical and nursing) sent to all participating hospitals	1 day ( once during the study)	No