NCT01563393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

6.2 years

First QC Date

February 22, 2012

Last Update Submit

January 16, 2021

Conditions

Malnutrition

Keywords

tool for nutritional evaluationchildrenmalnutrition

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

STAMP using

OTHER

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

No STAMP using

OTHER

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

Interventions

questionnaire STAMP and dietaryOTHER

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.

Also known as: STAMP using
STAMP using
No interventionOTHER

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

Also known as: No STAMP using
No STAMP using

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Diet

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Raanan Shamir, Professor

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Institute of Gastroenterology, Nutrition and Liver Diseases

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 27, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

IL(1)