Validation of a STAMP in Hospitalized Children and the Effect of Its Use on the Awareness of the Medical Staff (STAMP)
|ClinicalTrials.gov Identifier: NCT01563393|
Recruitment Status : Unknown
Verified April 2016 by raanan shamir, Rabin Medical Center.
Recruitment status was: Recruiting
First Posted : March 27, 2012
Last Update Posted : April 12, 2016
Children hospitalized due to an acute disease may suffer from acute malnutrition or chronic malnutrition caused by chronic diseases. According to various studies, about 10-20% of those admitted to hospitals in different countries suffer from malnutrition or are at risk of malnutrition.
Several pediatric nutritional screening tools were recently published. However, there is no conventional pediatric nutritional screening tool and the effect of the recently published tools on further nutritional risk and the behavior of the attending staff are unclear.
Study objectives: to test the validity and reliability of the STAMP nutritional screening tool (Screening Tool for the Assessment of Malnutrition in Pediatrics) among children hospitalized in a pediatric medical center and to examine the effect of the STAMP tool use on the attitude of the medical staff to the patient nutritional status.
An additional objective is to compare the skill of a nurse versus a dietician in performing the evaluation according to STAMP.
Methods: for the validation, 50 children between 1 and 17 years of age from internal medicine and surgical departments 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. All the children will undergo STAMP evaluation by a nurse and another investigating dietician as well.
In order to examine the effect of the tool on the medical staff awareness, 300 files of hospitalized children will be tested: 150 files at the beginning of the study and prior to using the tool and 150 after 6 months at the same ages and in the same departments.
The effect of using the STAMP questionnaire will be examined according to the results of data collection from the beginning of the study and after 6 months. Questionnaire use, recording of appropriate diagnoses, collection of blood tests demonstrating the nutritional status, weight, height and waist circumference measurements will be obtained from the patients' medical files.
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition||Other: questionnaire STAMP and dietary Other: No intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||464 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Validation of a Nutritional Risk Screening Tool- STAMP in Hospitalized Children and the Effect of Its Use on the Awareness of the Medical Staff|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||November 2016|
Active Comparator: STAMP using
Children between 1 and 17 years of age from internal medicine and surgical departments 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
Placebo Comparator: No STAMP using
In order to examine the effect of the tool on the medical staff awareness, 364 files of hospitalized children will be tested: 182 files at the beginning of the study and prior to using the tool and 182 after 6 months at the same ages and in the same departments.
Other: No intervention
The Placebo Comparator arm children got the classic care that practiced in hospitalization
Other Name: No STAMP using
- Validity and reliability [ Time Frame: one year ]The height / weight tables accepted in England, CDC (Centers for Disease Control) and WHO (World Health Organization) will be used in order to compare weight and height. 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, patient's ability to comply with the nutritional requirements related to his age etc.
- Validity and efficiency [ 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. In order to examine questionnaire acceptance by the medical staff, time period required to complete the questionnaire will be measured and in addition, the staff will be required to express their opinion regarding the speed and ease of using the questionnaire using the 4-point Likert scale. The staff will be asked about their subjective opinion about using the questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563393
|Contact: Luba Marderfeld, Mrs.||+972-543173277||LubaMa@clalit.org.il|
|Contact: Chen Shnaiderman, Mrs.||+firstname.lastname@example.org|
|Schneider Children's Medical Center of Israel||Recruiting|
|Petach Tikva, Israel, 49202|
|Principal Investigator:||Raanan Shamir, Professor||Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel|