Nutritional DisorderNCT04301791
Impact of Nutritional Status on Clinical Outcome in PICU
An observational study of Nutritional Disorder, run by Assiut University.
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 . Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Nutritional Disorder
- What is being tested?
- nutritional status
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Child, Adult
Study population: children age from one month to 18 years with no chronic diseases admitted at PICU at Assiut university hospital
Who may be able to join
- All children admitted to PICU with nutritional disorders
- Children with acute diseases and anthropometric measurements taken within first 24hours
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: the Impact of Nutritional Status on Clinical Outcome of Children Admitted in PICU OF Assuit Children University Hospital
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.
Read the detailed 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
- Conditions
- Nutritional Disorder
- Being tested
- nutritional status
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional statusOther
impact of nutritional status on clinical outcome of children admitted in PICU
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Nutritional DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Adel Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301791
- Sponsor's protocol ID
- nutritional status
- Status last verified
- Mar 2020
- First submitted
- 1 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 10511607Marcos 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.
PubMed 12947457Hulst 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.
PubMed 15030962Kielmann 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.
PubMed 78007Numa 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.
PubMed 21453507Bagri 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.
PubMed 25804317Czaja 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.
PubMed 20581732Slater 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.
PubMed 12541154Prince 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.
PubMed 25034475Mehta 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.
PubMed 22564954Barker 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.
PubMed 21556200Moreno 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.
PubMed 23848094Cahill 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.
PubMed 19851094de 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.
PubMed 21872433
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Impact of Nutritional Status on Clinical Outcome of Children Admitted in PICU OF Assuit Children University Hospital
- ClinicalTrials.gov ID
- NCT04301791
- Acronym / sponsor ID
- nutritional status
- Conditions
- Nutritional Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- children age from one month to 18 years with no chronic diseases admitted at PICU at Assiut university hospital
Key inclusion criteria (2 listed)
- All children admitted to PICU with nutritional disorders
- Children with acute diseases and anthropometric measurements taken within first 24hours
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional statusimpact of nutritional status on clinical outcome of children admitted in PICU | Other | – |
Primary outcome
the correlation between nutritional status of children admitted in PICU and outcomes
Time frame: 2 years
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 10511607Calle 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.
- Background: PubMed 12947457Marcos 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.
- Background: PubMed 15030962Hulst 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.
- Background: PubMed 78007Kielmann 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.
- Background: PubMed 21453507Numa 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.
- Background: PubMed 25804317Bagri 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.
- Background: PubMed 20581732Czaja 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.
- Background: PubMed 12541154Slater 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.
- Background: PubMed 25034475Prince 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.
- Background: PubMed 22564954Mehta 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.
- Background: PubMed 21556200Barker 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.
- Background: PubMed 23848094Moreno 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.
- WHO Multicentre Growth Reference Study Group. WHO Child Growth Standards: Length/Height-for-Age, Weight-for-Age, Weight-for Length, Weight-for-Height and Body Mass Index-for-Age. Methods and Development. Geneva, Switzerland: World Health OrganizationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hager adel ali, postgraduate (01118036639, adelhagar652@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the correlation between nutritional status of children admitted in PICU and outcomes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04301791, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.