Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children

Malnutrition Clinical Trial

— STAMP  

Official title:

Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children on Medical Staff Awareness and Health-Related Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563393
• Other study ID #: RMC12-6634
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: July 2018

Study information

• Verified date: January 2021
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children hospitalized due to an acute disease may suffer from acute malnutrition or chronic malnutrition caused by chronic diseases.

We aimed to evaluate the use of the Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) among children admitted in a pediatric hospital, and assess its effect on medical staff's awareness to nutritional status and health outcomes at discharge.

Description:

Malnutrition prevalence upon admission to paediatric hospitals remains considerably high, ranging from 7.3 to 17.9% in the developed world with higher prevalence rates in infants and toddlers and particularly high rates for specific medical conditions. Several studies have reported deterioration of nutritional status during hospitalization. Screening children for malnutrition risk is recommended by a number of international organizations such as the American Society for Parenteral and Enteral Nutrition (ASPEN), the European Society for Parenteral and Enteral Nutrition (ESPEN) and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN).

Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) was chosen for this study because it is highly applicable, frequently used by nurses and has shown high reproducibility, as well as concurrent and predictive validity. The tool was developed by McCarthy et al11 in England. It collects the following information to assess nutritional risk for a patient: discrepancy between the weight and height percentile weight for the age expected nutritional risk caused by clinical diagnosis, recent changes in the appetite. The assessment results are used to define if there is a need for a referral to a full nutritional assessment.

We aimed to evaluate the use of the Screening Tool for the Assessment of Malnutrition in Pediatrics among children admitted in a pediatric hospital, and assess its effect on medical staff's awareness to nutritional status and health outcomes at discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion Criteria:

• patients hospitalized during the study,

• patients hospitalized for more than 24 hours. The children will be enrolled from 3 internal medicine and surgical departments, children's parents will give their consent and will be able to understand and sign the consent forms

Exclusion Criteria:

• children < 1 year of age,

• children > 17 years of age,

• children hospitalized for less than 24 hours,

• children in the intensive care unit or following hospitalization in the intensive care unit.

Statistical analysis for STAMP validation will be performed using Kappa (K) test. Chi square test will be used in order to calculate the effect of STAMP use

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• questionnaire STAMP and dietary
Children will undergo a complete evaluation by an investigating dietician and assessment by the STAMP tool in order to determine the extent of the nutritional risk on a numerical scale. According to findings children will get the dietary recommendations.
• No intervention
The Placebo Comparator arm children got the classic care that practiced in hospitalization

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity and reliability	The growth chart tables accepted in England, CDC (Centers for Disease Control will be used in order to compare weight and height and generate them into the BMI. The children will be divided into 3 nutritional risk groups: low, moderate and high according to the STAMP toll assessment and the results will be compared to the dietician's complete assessment. Nutritional assessment will include: demographic and medical data, daily nutritional intake, blood tests, anthropometric measurements.	one year
Primary	Effect of STAMP on staff's awareness to nutritional status	Methods for testing the effect of STAMP tool use on the attitude of the medical staff to the nutritional status, measured by collection of data related to the nutritional status and recording them in the patient's file.	one year
Primary	Health outcome at discharge: weigh (KG)	Health outcomes on the discharge of the children who are screened by STAMP will be compared to outcomes of children are not. The data for this comparison includes weight changes during hospitalisation measured in Kg. and changes in haemoglobin and albumin levels. Controls are matched by age, gender, and STAMP risk score will be calculated based on the retrieved information from medical files.	one year
Primary	Health outcome at discharge: length of stay (number of days)	Health outcomes on the discharge of the children who are screened by STAMP will be compared to outcomes of children are not. The data for this comparison includes length of stay (LOS). Controls are matched by age, gender, and STAMP risk score will be calculated based on the retrieved information from medical files.	One year
Primary	Health outcome at discharge: number of recurrent hospitalisations	Health outcomes on the discharge of the children who are screened by STAMP will be compared to outcomes of children are not. The data for this comparison includes the number of recurrent hospitalisations. Controls are matched by age, gender, and STAMP risk score will be calculated based on the retrieved information from medical files.	One year
Primary	Health outcome at discharge: haemoglobin (g/dl)	Health outcomes on the discharge of the children who are screened by STAMP will be compared to outcomes of children are not. The data for this comparison includes changes in haemoglobin during hospitalisation. Controls are matched by age, gender, and STAMP risk score will be calculated based on the retrieved information from medical files.	One year
Primary	Health outcome at discharge: albumin (g/dl)	Health outcomes on the discharge of the children who are screened by STAMP will be compared to outcomes of children are not. The data for this comparison includes changes in albumin levels during hospitalisation. Controls are matched by age, gender, and STAMP risk score will be calculated based on the retrieved information from medical files.	One year