NCT03408067

Brief Summary

In several hospital clinical trials, the nutritional intervention has been proven to be effective in preventing and/or reducing malnutrition. Therefore, a procedure to identify the risk of malnutrition or malnourishment in hospitalized patients is necessary to guarantee an adequate and timely nutritional treatment. Aims: to compare two validated nutritional screening tools: NRS 2002 and SGA. These are used to identify the risk of malnutrition or malnourishment in hospitalized patients. Patients and Methods: The study is currently carried out at the Federico II University Hospital of Naples, Italy. The in patients admitted in the Clinical Wards since September 2016 are being evaluated. The two screening test results and the assessment of the patients' parameters are collected within 72 hours following admission. Age, sex, height, weight, Body Mass Index (BMI), calf circumference and dominant hand of the participants are being noted. Venous blood samples are collected for routine biochemistry and inflammatory parameters ; all measurements are determined by routine laboratory methods at the Department of Laboratory Medicine of the University Hospital Federico II, Naples.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

December 19, 2017

Last Update Submit

January 22, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • malnutrition scored with NRS 2002 questionnaire

    scoring scale (units 0-3) : 0 = nourished patient; 1 = mild malnutrition, 2 = moderate malnutrition, 3 = severe malnutrition

    5 minutes

  • malnutrition scored with SGA questionnaire

    scoring scale (units a-c) : a = nourished patient; b = mildly malnourished; c = severely malnourished

    5 minutes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital Wards inpatients

You may qualify if:

  • Age: ≥ 18 years.

You may not qualify if:

  • Inpatients of the intensive care unit after admission from Emergency Room;
  • Pregnancy and breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fabrizio Pasanisi

Napoli, 80131, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Fabrizio Pasanisi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 23, 2018

Study Start

September 1, 2016

Primary Completion

January 1, 2018

Study Completion

September 1, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations