NCT04862728

Brief Summary

  • Assess the nutritional status of critically ill children using different nutritional assessment tools in management.
  • Assess accuracy and validity of screening tools in diagnosis of malnutrition by the following:
  • Strong kids
  • Stamp
  • PYMS
  • Assess the effect of early versus late enteral nutrition on the outcome and predict the complication associated with enteral feeding.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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

First Submitted

Initial submission to the registry

April 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 17, 2021

Last Update Submit

April 23, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by Screening Tool for the Assessment of Malnutrition in Pediatrics.

    Screening Tool for the Assessment of Malnutrition in Pediatrics evaluates patient's clinical diagnosis nutritional intake during hospitalization and anthropometric measurements malnutrition risk. the measured value of the child's height and weight will recorded and compared to reference values by age. and gender

    baseline

  • Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by Screening Tool for Impaired Nutritional Status and Growth in kids.

    Screening Tool for Impaired Nutritional Status and Growth (STRONG kids) consists of subjective clinical assessment high risk diseases nutritional intake and losses. weight, poor weight gain Patients classified at high nutritional risk have a longer hospitalization and a negative standard deviation score for weight for height which indicated a state of acute malnutrition,this tool appeared rapid and easy to use, additionally it may predict long of hospital stay and identifies a need for nutritional interventions during the hospitalization.

    baseline

  • Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by The Pediatric Yorkhill Malnutrition Score.

    The Pediatric Yorkhill Malnutrition Score (PYMS) is adopted among patients between 1 and 16 years of age. It assesses BMI history of recent weight loss changes in nutritional intake and the expected effect of current medical condition on patient's nutritional status

    baseline

Secondary Outcomes (1)

  • the importance of early versus late enteral nutrition for patient in PICU.

    baseline

Interventions

Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) evaluates patient's clinical diagnosis, nutritional intake during hospitalization and anthropometric measurements, developing a care plan based on the child's overall malnutrition risk (low, medium or high).Screening Tool for Impaired Nutritional Status and Growth (STRONG kids). It consists of four items: subjective clinical assessment, high-risk diseases, nutritional intake and losses, weight loss or poor weight gain. Patients classified at high nutritional risk have a longer hospitalization and a negative standard deviation score (SDS) for weight-for-height (WFH), which indicated a state of acute malnutrition.The Pediatric Yorkhill Malnutrition Score (PYMS) is adopted among medical and surgical patients between 1 and 16 years of age. The PYMS assesses four items: BMI, history of recent weight loss,

Also known as: early versus late enteral nutrition on the outcome and predict complication.

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Study population will be taken from pediatric intensive care unit (PICU) at Assiut university Children Hospital.

You may qualify if:

  • Critically ill children aged 1-5 years admitted to PICU.

You may not qualify if:

  • Infants before the age of one year and children after the age of five years.
  • Any child with chronic illness.
  • Patients with multiorgans failure.
  • Children with congenital anomalies.
  • Children on renal dialysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13.

  • Gerasimidis K, Keane O, Macleod I, Flynn DM, Wright CM. A four-stage evaluation of the Paediatric Yorkhill Malnutrition Score in a tertiary paediatric hospital and a district general hospital. Br J Nutr. 2010 Sep;104(5):751-6. doi: 10.1017/S0007114510001121. Epub 2010 Apr 19.

  • McCarthy H, Dixon M, Crabtree I, Eaton-Evans MJ, McNulty H. The development and evaluation of the Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP(c)) for use by healthcare staff. J Hum Nutr Diet. 2012 Aug;25(4):311-8. doi: 10.1111/j.1365-277X.2012.01234.x. Epub 2012 May 9.

  • Joosten KF, Hulst JM. Nutritional screening tools for hospitalized children: methodological considerations. Clin Nutr. 2014 Feb;33(1):1-5. doi: 10.1016/j.clnu.2013.08.002. Epub 2013 Aug 31.

  • Skillman HE, Wischmeyer PE. Nutrition therapy in critically ill infants and children. JPEN J Parenter Enteral Nutr. 2008 Sep-Oct;32(5):520-34. doi: 10.1177/0148607108322398.

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • zenab Mohie EL Deen, professor

    professor at pediatric departement, faculty of medecine, assiut university

    STUDY CHAIR
  • Osama Al Asheer, professor

    professor at pediatric departement, faculty of medecine, assiut university

    STUDY DIRECTOR
  • Amira Shalaby, lecturer

    lecturer at pediatric departement, fsculty of medicine, assiut university

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 17, 2021

First Posted

April 28, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

April 28, 2021

Record last verified: 2021-04