Role of Nutritional Intervention in Critically Ill Child

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04862728
Collaborator
(none)
100
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: - Strong kids screening tool - Stamp screening tool - PYMS screening tool

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Role of Various Nutritional Interventions in Management of Critically Ill Child
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Outcome Measures

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hanan Saad Ahmed Hamdallah, principle investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04862728
Other Study ID Numbers:
  • malnutrition in critically ill
First Posted:
Apr 28, 2021
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021