Clinical trial NCT04862728: Role of Nutritional Intervention in Critically Ill Child
Official title: Role of Various Nutritional Interventions in Management of Critically Ill Child
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutrition Disorder, Child
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be taken from pediatric intensive care unit (PICU) at Assiut university Children Hospital.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by Screening Tool for the Assessment of Malnutrition in Pediatrics.
timeFrame: baseline
measure: Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by Screening Tool for Impaired Nutritional Status and Growth in kids.
timeFrame: baseline
measure: Identifying high risk group of malnutrition among patient in PICU by nutritional assesement by The Pediatric Yorkhill Malnutrition Score.
timeFrame: baseline
Secondary outcomes:
measure: the importance of early versus late enteral nutrition for patient in PICU.
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: professor at pediatric departement, faculty of medecine, assiut university
name: zenab Mohie EL Deen, professor
role: STUDY_CHAIR
affiliation: professor at pediatric departement, faculty of medecine, assiut university
name: Osama Al Asheer, professor
role: STUDY_DIRECTOR
affiliation: lecturer at pediatric departement, fsculty of medicine, assiut university
name: Amira Shalaby, lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.