Validation of the STAMP Screening Tool For Pediatric Nutritional Risk

Malnutrition Clinical Trial

— STAMP2  

Official title:

Validation of the STAMP Screening Tool For Pediatric Nutritional Risk To Be Used in the Ambulatory Setting.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718769
• Other study ID #: MMC206-2011KCTIL
• Status: Completed
• Phase: N/A
• First received: March 20, 2012
• Last updated: April 26, 2016
• Start date: October 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial Summary

Background: Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. In addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. Studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. This risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. Improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. In Israel, nutritional screening in not conducted among children since there is no proper validated screening tool. Study objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file.

Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements.

A statistical analysis to examine the validity of the STAMP Tool shall be carried out using the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi square test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

1. children between 1 and 6 years old

2. children treated at the clinics participating in the study

Exclusion Criteria:

1. Lack of consent or lack of Hebrew proficiency

2. children that not receiving treatment in day hospitalization at any hospital

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• questionnaire STAMP
Children will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool.

Locations

Country	Name	City	State
Israel	Netka child healthcare services	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity and reliability will be determined by comparing questionnaire scores with the complete nutritional assessment scores.	The STAMP questionnaire scores will be compared to a complete nutritional assessment conducted by a dietitian in Clalit Health Care Service clinics.	one year	No
Primary	A change in frequency of recording of nutritional diagnoses for malnutrition; abnormal growth curves, FTT (Failure To Thrive), underweight, overweight, and obesity.	The following will be evaluated before and after conducting the study: % of children < percentile 5, % of children > percentile 85, % of children > percentile 95, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER.	Baseline and after 1 year	No
Secondary	To evaluate the frequency of malnutrition among children in the community in the study clinics.	The following will be measured: Height, weight and BMI recording,% of children > percentile 95 in the weight-height curve, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: albumin, hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER, exposure to professional material on the subject of nutrition (leaflets, videos) before and after intervention, change in the number of children under growth follow up by a multi-professional team.	one year	No
Secondary	To evaluate the ratio of children with acute or chronic malnutrition out of all malnourished children	The following will be measured: Height, weight and BMI recording,% of children > percentile 95 in the weight-height curve, frequency of referrals to a dietician, frequency of blood counts, frequency of tests: albumin, hemoglobin, transferrin and TLC, frequency of anemia, differences in infection diagnosis (pneumonia, UTI, etc.), frequency of referrals to the ER, exposure to professional material on the subject of nutrition (leaflets, videos) before and after intervention, change in the number of children under growth follow up by a multi-professional team.	one year	No