NCT04301791

Brief Summary

Malnutrition is believed to be associated with clinical outcomes in ill patients and several studies have shown that nutrition status play a major role in disease prognosis in adults . Different authors have described an increase in morbidity and mortality attributable to malnutrition, as it lead to state of partial immunosuppression, delay wound healing ,causes muscular atrophy and increase length of stay.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

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

March 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 1, 2020

Last Update Submit

March 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • the correlation between nutritional status of children admitted in PICU and outcomes

    nutritional status measured by weight in kilograms and height in meters will be combined to report BMI for Z scoreand outcomes measured by pediatric index of mortality2 (PIM2)

    2 years

Interventions

impact of nutritional status on clinical outcome of children admitted in PICU

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children age from one month to 18 years with no chronic diseases admitted at PICU at Assiut university hospital

You may qualify if:

  • All children admitted to PICU with nutritional disorders
  • Children with acute diseases and anthropometric measurements taken within first 24hours

You may not qualify if:

  • children with underlying chronic diseases (eg cerebral palsy ,type 1 or 2 diabetes , epilepsy, metabolic diseases, inflammatory bowel disease , liver cirrhosis , immunodeficiency , autoimmune disordes , malignancy , chronic kidney disease) and postoperative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath CW Jr. Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med. 1999 Oct 7;341(15):1097-105. doi: 10.1056/NEJM199910073411501.

    PMID: 10511607BACKGROUND
  • Marcos A, Nova E, Montero A. Changes in the immune system are conditioned by nutrition. Eur J Clin Nutr. 2003 Sep;57 Suppl 1:S66-9. doi: 10.1038/sj.ejcn.1601819.

    PMID: 12947457BACKGROUND
  • Hulst J, Joosten K, Zimmermann L, Hop W, van Buuren S, Buller H, Tibboel D, van Goudoever J. Malnutrition in critically ill children: from admission to 6 months after discharge. Clin Nutr. 2004 Apr;23(2):223-32. doi: 10.1016/S0261-5614(03)00130-4.

    PMID: 15030962BACKGROUND
  • Kielmann AA, McCord C. Weight-for-age as an index of risk of death in children. Lancet. 1978 Jun 10;1(8076):1247-50. doi: 10.1016/s0140-6736(78)92478-9.

    PMID: 78007BACKGROUND
  • Numa A, McAweeney J, Williams G, Awad J, Ravindranathan H. Extremes of weight centile are associated with increased risk of mortality in pediatric intensive care. Crit Care. 2011;15(2):R106. doi: 10.1186/cc10127. Epub 2011 Mar 31.

    PMID: 21453507BACKGROUND
  • Bagri NK, Jose B, Shah SK, Bhutia TD, Kabra SK, Lodha R. Impact of Malnutrition on the Outcome of Critically Ill Children. Indian J Pediatr. 2015 Jul;82(7):601-5. doi: 10.1007/s12098-015-1738-y. Epub 2015 Mar 26.

    PMID: 25804317BACKGROUND
  • Czaja AS, Scanlon MC, Kuhn EM, Jeffries HE. Performance of the Pediatric Index of Mortality 2 for pediatric cardiac surgery patients. Pediatr Crit Care Med. 2011 Mar;12(2):184-9. doi: 10.1097/PCC.0b013e3181e89694.

    PMID: 20581732BACKGROUND
  • Slater A, Shann F, Pearson G; Paediatric Index of Mortality (PIM) Study Group. PIM2: a revised version of the Paediatric Index of Mortality. Intensive Care Med. 2003 Feb;29(2):278-85. doi: 10.1007/s00134-002-1601-2. Epub 2003 Jan 23.

    PMID: 12541154BACKGROUND
  • Prince NJ, Brown KL, Mebrahtu TF, Parslow RC, Peters MJ. Weight-for-age distribution and case-mix adjusted outcomes of 14,307 paediatric intensive care admissions. Intensive Care Med. 2014 Aug;40(8):1132-9. doi: 10.1007/s00134-014-3381-x. Epub 2014 Jul 18.

    PMID: 25034475BACKGROUND
  • Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8.

    PMID: 22564954BACKGROUND
  • Barker LA, Gout BS, Crowe TC. Hospital malnutrition: prevalence, identification and impact on patients and the healthcare system. Int J Environ Res Public Health. 2011 Feb;8(2):514-27. doi: 10.3390/ijerph8020514. Epub 2011 Feb 16.

    PMID: 21556200BACKGROUND
  • Moreno Villares JM, Varea Calderon V, Bousono Garcia C, Lama More R, Redecillas Ferreiro S, Pena Quintana L; Sociedad Espanola de Gastroenterologia. [Nutrition status on pediatric admissions in Spanish hospitals; DHOSPE study]. Nutr Hosp. 2013 May-Jun;28(3):709-18. doi: 10.3305/nh.2013.28.3.6356. Spanish.

    PMID: 23848094BACKGROUND
  • Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is "best achievable" practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c0263d.

    PMID: 19851094BACKGROUND
  • de Souza Menezes F, Leite HP, Koch Nogueira PC. Malnutrition as an independent predictor of clinical outcome in critically ill children. Nutrition. 2012 Mar;28(3):267-70. doi: 10.1016/j.nut.2011.05.015. Epub 2011 Aug 27.

    PMID: 21872433BACKGROUND

Related Links

MeSH Terms

Conditions

Nutrition Disorders

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Central Study Contacts

hager adel ali, postgraduate

CONTACT

amal abdsalam soliman, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 1, 2020

First Posted

March 10, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

March 10, 2020

Record last verified: 2020-03