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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04301791
Other study ID # nutritional status
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2020
Est. completion date January 2022

Study information

Verified date March 2020
Source Assiut University
Contact hager adel ali, postgraduate
Phone 01118036639
Email adelhagar652@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Several studies have investigated the predictive role of an extremely low body weight on disease prognosis and outcomes among general and critically ill children .They enrolled all patients consecutively admitted to pediatric intensive care unit PICU) , therefore , being underweight may have resulted from endocrine diseases, genetic syndromes or other systemic underlying illnesses .

The impact of low body weight on outcomes of acutely critically ill but previously healthy children is still unknown.

Many studies evaluate the clinical status and outcome by pediatric index of mortality (PIM2) as a popular and reliable predictive score .

In this study, we will investigate the impact of being underweight or proper weight on mortality and morbidity among acute critically ill children with no genetic, endocrine, or chronic systemic illness at PICU admission


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date January 2022
Est. primary completion date December 2021
Accepts healthy volunteers
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria:

1. All children admitted to PICU with nutritional disorders

2. Children with acute diseases and anthropometric measurements taken within first 24hours

Exclusion Criteria:

1-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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (14)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hulst J, Joosten K, Zimmermann L, Hop W, van Buuren S, Büller 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. — View Citation

Kielmann AA, McCord C. Weight-for-age as an index of risk of death in children. Lancet. 1978 Jun 10;1(8076):1247-50. — View Citation

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. Review. — View Citation

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. — View Citation

Moreno Villares JM, Varea Calderón V, Bousoño García C, Lama Moré R, Redecillas Ferreiro S, Peña Quintana L; Sociedad Española de Gastroenterología. [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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2003 Jan 23. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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