Validation and Impact of Paediatric Malnutrition Screening Tool in Hospitalised Children

NCT ID: NCT01563393

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Malnutrition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

questionnaire STAMP and dietary

Intervention Type OTHER

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 STAMP using

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

Group Type OTHER

No intervention

Intervention Type OTHER

The Placebo Comparator arm children got the classic care that practiced in hospitalization

Interventions

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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.

Intervention Type OTHER

No intervention

The Placebo Comparator arm children got the classic care that practiced in hospitalization

Intervention Type OTHER

Other Intervention Names

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STAMP using No STAMP using

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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raanan shamir

Chairman, Institute of Gastroenterology, Nutrition and Liver Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raanan Shamir, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel

Locations

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Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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RMC12-6634

Identifier Type: -

Identifier Source: org_study_id

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