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

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ClinicalTrials.gov Identifier: NCT01563393
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
raanan shamir, Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
Malnutrition Other: questionnaire STAMP and dietary Other: No intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 484 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children on Medical Staff Awareness and Health-Related Outcomes
Study Start Date : May 2012
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
STAMP using
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.
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.
Other Name: STAMP using

No STAMP using
Relevant to the third part of the study. Other 30 children that are not screened by dietitian and either not by STAMP
Other: No intervention
The Placebo Comparator arm children got the classic care that practiced in hospitalization
Other Name: No STAMP using




Primary Outcome Measures :
  1. Validity and reliability [ Time Frame: one year ]
    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.

  2. Effect of STAMP on staff's awareness to nutritional status [ Time Frame: one year ]
    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.

  3. Health outcome at discharge: weigh (KG) [ Time Frame: one year ]
    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.

  4. Health outcome at discharge: length of stay (number of days) [ Time Frame: One year ]
    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.

  5. Health outcome at discharge: number of recurrent hospitalisations [ Time Frame: One year ]
    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.

  6. Health outcome at discharge: haemoglobin (g/dl) [ Time Frame: One year ]
    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.

  7. Health outcome at discharge: albumin (g/dl) [ Time Frame: One year ]
    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.



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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563393


Locations
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Israel
Schneider Children's Medical Center of Israel
Petach Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Raanan Shamir, Professor Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel
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Responsible Party: raanan shamir, Chairman, Institute of Gastroenterology, Nutrition and Liver Diseases, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01563393    
Other Study ID Numbers: RMC12-6634
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Keywords provided by raanan shamir, Rabin Medical Center:
tool for nutritional evaluation
children
malnutrition
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders