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Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children (STAMP)

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
questionnaire STAMP and dietary
No intervention
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring tool for nutritional evaluation, children, malnutrition

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schneider Children's Medical Center of Israel

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

STAMP using

No STAMP using

Arm Description

Relevant to the third part of the study. 30 Children between 1 and 17 years of age from internal medicine department 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.

Relevant to the third part of the study. Other 30 children that are not screened by dietitian and either not by STAMP

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2012
Last Updated
January 16, 2021
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01563393
Brief Title
Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children
Acronym
STAMP
Official Title
Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children on Medical Staff Awareness and Health-Related Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
tool for nutritional evaluation, children, malnutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
484 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STAMP using
Arm Type
Other
Arm Description
Relevant to the third part of the study. 30 Children between 1 and 17 years of age from internal medicine department 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.
Arm Title
No STAMP using
Arm Type
Other
Arm Description
Relevant to the third part of the study. Other 30 children that are not screened by dietitian and either not by STAMP
Intervention Type
Other
Intervention Name(s)
questionnaire STAMP and dietary
Other Intervention Name(s)
STAMP using
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No intervention
Other Intervention Name(s)
No STAMP using
Intervention Description
The Placebo Comparator arm children got the classic care that practiced in hospitalization
Primary Outcome Measure Information:
Title
Validity and reliability
Description
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.
Time Frame
one year
Title
Effect of STAMP on staff's awareness to nutritional status
Description
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.
Time Frame
one year
Title
Health outcome at discharge: weigh (KG)
Description
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.
Time Frame
one year
Title
Health outcome at discharge: length of stay (number of days)
Description
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.
Time Frame
One year
Title
Health outcome at discharge: number of recurrent hospitalisations
Description
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.
Time Frame
One year
Title
Health outcome at discharge: haemoglobin (g/dl)
Description
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.
Time Frame
One year
Title
Health outcome at discharge: albumin (g/dl)
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raanan Shamir, Professor
Organizational Affiliation
Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tikva
ZIP/Postal Code
49202
Country
Israel

12. IPD Sharing Statement

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Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children

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