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Status unknownNCT04862728Updated Apr 28, 2021

Role of Nutritional Intervention in Critically Ill Child

An observational study in Nutrition Disorder, Child, sponsored by Assiut University. Status unknown. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
1 Year to 5 Years
Sex
All
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Study 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.
Read the 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.

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Conditions studied

  • Nutrition Disorder, Child
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In context

Nutrition Disorders

275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.

This study's planned enrollment of 100 is close to the median of 108 across 74 observational studies indexed under Nutrition Disorders.

Browse Nutrition Disorders studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • Other- Strong kids screening tool - Stamp screening tool - PYMS screening tool

    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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

  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.

    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.

    Time frame: baseline

  3. 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

    Time frame: baseline

Secondary outcomes

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

    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.

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 19682776 ↗
  • 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. PubMed 20398432 ↗
  • 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. PubMed 22568534 ↗
  • 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. PubMed 24050847 ↗
  • 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. PubMed 18753390 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04862728
Lead sponsor
Assiut University
Responsible party
Hanan Saad Ahmed Hamdallah (principle investigator, Assiut University) — Principal investigator
First posted
Apr 28, 2021
Start date
Jun 2021 (estimated)
Primary completion
Jun 2022 (estimated)
Completion
Sep 2022 (estimated)
Last update
Apr 28, 2021

Study contacts

Hanan Hamdallah
Contact
drsmart8989@gmail.com
00201011540871
zenab Mohie EL Deen, professor
study chair · professor at pediatric departement, faculty of medecine, assiut university
Osama Al Asheer, professor
study director · professor at pediatric departement, faculty of medecine, assiut university
Amira Shalaby, lecturer
study director · lecturer at pediatric departement, fsculty of medicine, assiut university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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