Role of Nutritional Intervention in Critically Ill Child

April 23, 2021 updated by: Hanan Saad Ahmed Hamdallah, Assiut University

Role of Various Nutritional Interventions in Management of Critically Ill Child

  • 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Malnutrition affects millions of children throughout the World. According to ESPEN nutritional risk screening tools have been designed to detect protein and energy under nutrition and predict if under nutrition may develop or worsen. The Screening was validated Tool for Assessment of Malnutrition in Pediatrics (STAMP) that evaluates patient's clinical diagnosis, nutritional intake during hospitalization and anthropometric measurements, developing a care plan based on the child's overall malnutrition risk. The Screening Tool for Impaired Nutritional Status and Growth (STRONG kids) consists of four items: clinical assessment, high-risk diseases, nutritional intake and losses, weight loss or poor weight gain.

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

Indirect calorimetry, calculated from analysis of the inspired and expired gases, is the best method for evaluating individual energy expenditure.

Protein requirements are highe. The catabolic effects of illness lead to negative nitrogen balance. Randomized protein-supplemented enteral diet achieved 3.1g/kg/day protein and positive nitrogen balance by PICU day 5.

Enteral nutrition is more physiological, simpler, can be started more quickly and cheaper, it does not require special preparation, and it can be started and modified at any time.

Par enteral nutrition has reserved for those patients with intestinal obstruction or severe gastrointestinal damage, ischemia, inflammation, hemorrhage, peritonitis and paralytic ileus.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by Screening Tool for the Assessment of Malnutrition in Pediatrics.
Time Frame: baseline
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.
Time Frame: baseline
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.
Time Frame: baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the importance of early versus late enteral nutrition for patient in PICU.
Time Frame: baseline
We will conduct this study to compare early (6-24 h) with late (after 24 h) initiation of enteral feeding in PICU. Enteral nutrition is more physiological,early enteral nutrition has a trophic effect on the intestinal mucosa, and stimulates the intestinal immune system, decreasing bacterial overgrowth and translocation; it therefore reduces the incidence of sepsis and multiorgan failure. Furthermore,early enteral nutrition is associated with fewer hepatic and metabolic complications than late and parentral nutrition.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: zenab Mohie EL Deen, professor, professor at pediatric departement, faculty of medecine, assiut university
  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

April 17, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • malnutrition in critically ill

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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