Validation of the STAMP Screening Tool For Pediatric Nutritional Risk

NCT01718769 | Completed

• 1 other identifier: MMC206-2011KCTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malnutrition

Keywords

Nutritional assessment; children; malnutrition

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• To evaluate the frequency of malnutrition among children in the community in the study clinics.

  one year

• To evaluate the ratio of children with acute or chronic malnutrition out of all malnourished children

  one year

Study Arms (2)

STAMP using

ACTIVE COMPARATOR

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.

Other: questionnaire STAMP

No STAMP using

PLACEBO COMPARATOR

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.

Other: questionnaire STAMP

Interventions

questionnaire STAMP OTHER

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.

No STAMP using; STAMP using

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children between 1 and 6 years old
• children treated at the clinics participating in the study

You may not qualify if:

• Lack of consent or lack of Hebrew proficiency
• children that not receiving treatment in day hospitalization at any hospital

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Netka child healthcare services

Tel Aviv, Israel

Location

Related Publications (1)

• Rub G, Marderfeld L, Poraz I, Hartman C, Amsel S, Rosenbaum I, Pergamentzev-Karpol S, Monsonego-Ornan E, Shamir R. Validation of a Nutritional Screening Tool for Ambulatory Use in Pediatrics. J Pediatr Gastroenterol Nutr. 2016 May;62(5):771-5. doi: 10.1097/MPG.0000000000001046.

  PMID: 26628448 DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

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: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: October 31, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 27, 2016

Record last verified: 2015-04

Locations

IL (1)