MalnutritionNCT07830966
Assessment of Nutritional Status in Critically Ill Children in PICU
An observational study of Malnutrition and Critical Illness, run by Assiut University.
Trial summary
This prospective cohort study aims to assess the nutritional status of critically ill children aged 1 month to 5 years admitted to the pediatric intensive care unit using a comprehensive ABCD approach including anthropometric, biochemical, clinical, and dietary assessment within 48 hours of admission, and to evaluate… Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Malnutrition, Critical Illness
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 10 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Critically ill children aged 1 month to 5 years admitted to PICU at Assiut University Children Hospital
Who may be able to join
- Age from 1 month to 5 years
- Admitted to PICU with expected length of stay greater than 48 hours
- Written informed consent from parents or legal guardians
Who cannot join
- Chronic renal or hepatic disease known to affect serum protein levels
- Incomplete medical records or discharged or transferred before first laboratory sample could be obtained
- Receiving nutritional support enteral or parenteral prior to PICU admission for condition unrelated to current critical illness
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Practical Approach for Identifying Malnutrition and Its Relation to Outcome in Critically Ill Children: A Prospective Cohort Study
This prospective cohort study aims to assess the nutritional status of critically ill children aged 1 month to 5 years admitted to the pediatric intensive care unit using a comprehensive ABCD approach including anthropometric, biochemical, clinical, and dietary assessment within 48 hours of admission, and to evaluate its association with clinical outcomes including duration of mechanical ventilation, length of PICU stay, and mortality.
Read the detailed description
Malnutrition is common among critically ill children in PICU with prevalence around 37 percent. This study will include children admitted to PICU at Assiut University Children Hospital with expected stay greater than 48 hours. Nutritional status will be assessed within 48 hours using anthropometric measurements weight height body mass index mid-upper arm circumference skinfold thickness, biochemical markers albumin prealbumin total protein C-reactive protein electrolytes, clinical examination for muscle and fat loss, and dietary intake. Children will be followed up to 30 days for clinical outcomes.
- Conditions
- Malnutrition, Critical Illness
- Keywords
- PICU, ABCD, Pediatric critical care, Mechanical ventilation, Assiut, nutritional assessment
- Medical subject headings
- Malnutrition, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill children in PICU | Children aged 1 month to 5 years admitted to PICU with expected stay greater than 48 hours who will undergo comprehensive nutritional assessment using ABCD approach within 48 hours of admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status at PICU admission assessed by ABCD approach
Number of children classified as malnourished based on comprehensive ABCD assessment including anthropometric measurements body mass index z-score mid-upper arm circumference skinfold thickness, biochemical markers albumin prealbumin total protein, clinical signs of muscle and fat loss, and dietary intake, obtained within 48 hours of PICU admission
Measured: At baseline within 48 hours of admission
Secondary outcomes (4)
Duration of mechanical ventilation
Length of mechanical ventilation in days
Measured: Up to 30 days
Length of PICU stay
Length of stay in the pediatric intensive care unit in days
Measured: Up to 30 days
PICU mortality
Number of children who die during PICU stay
Measured: Up to 30 days
Feeding intolerance and refeeding syndrome
Number of children who develop feeding intolerance or refeeding syndrome during PICU stay
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion25 Sep 2027 (estimated)
- Study completion10 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Prospective
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Atef Felly, Assiut University
- Investigators
- Azza A Eltayeb, prof, Study chair, pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830966
- Sponsor's protocol ID
- PICU-Nutrition-Assiut-26
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tume LN, Valla FV, Joosten K, Jotterand Chaparro C, Latten L, Marino LV, Macleod I, Moullet C, Pathan N, Rooze S, van Rosmalen J, Verbruggen SCAT. Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations. Intensive Care Med. 2020 Mar;46(3):411-425. doi: 10.1007/s00134-019-05922-5. Epub 2020 Feb 20.
PubMed 32077997Hulst JM, Huysentruyt K, Gerasimidis K, Shamir R, Koletzko B, Chourdakis M, Fewtrell M, Joosten KF; Special Interest Group Clinical Malnutrition of ESPGHAN. A Practical Approach to Identifying Pediatric Disease-Associated Undernutrition: A Position Statement from the ESPGHAN Special Interest Group on Clinical Malnutrition. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):693-705. doi: 10.1097/MPG.0000000000003437. Epub 2022 Mar 3.
PubMed 35258497Abera EG, Sime H. The prevalence of malnutrition among critically ill children: a systematic review and meta-analysis. BMC Pediatr. 2023 Nov 21;23(1):583. doi: 10.1186/s12887-023-04419-x.
PubMed 37986053Agrawal A, Sharma S, Janjua D, Jadon G, Chanchlani R, Dsouza V. Impact of nutritional status on the mortality and clinical outcomes of children admitted to the pediatric intensive care unit: A systematic review and meta-analysis. Clin Nutr. 2025 Aug;51:28-39. doi: 10.1016/j.clnu.2025.06.002. Epub 2025 Jun 6.
PubMed 40516325
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Approach for Identifying Malnutrition and Its Relation to Outcome in Critically Ill Children: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07830966
- Acronym / sponsor ID
- PICU-Nutrition-Assiut-26
- Conditions
- Malnutrition, Critical Illness
- Keywords
- PICU, ABCD, Pediatric critical care, Mechanical ventilation, Assiut, nutritional assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 25 Sep 2027 (estimated)
- Study completion
- 10 Jan 2028 (estimated)
- First posted
- 21 Sep 2026 (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.
This prospective cohort study aims to assess the nutritional status of critically ill children aged 1 month to 5 years admitted to the pediatric intensive care unit using a comprehensive ABCD approach including anthropometric, biochemical, clinical, and dietary assessment within 48 hours of admission, and to evaluate its association with clinical outcomes including duration of mechanical ventilation, length of PICU stay, and mortality.
Detailed description
Malnutrition is common among critically ill children in PICU with prevalence around 37 percent. This study will include children admitted to PICU at Assiut University Children Hospital with expected stay greater than 48 hours. Nutritional status will be assessed within 48 hours using anthropometric measurements weight height body mass index mid-upper arm circumference skinfold thickness, biochemical markers albumin prealbumin total protein C-reactive protein electrolytes, clinical examination for muscle and fat loss, and dietary intake. Children will be followed up to 30 days for clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill children in PICU | – | –Children aged 1 month to 5 years admitted to PICU with expected stay greater than 48 hours who will undergo comprehensive nutritional assessment using ABCD approach within 48 hours of admission |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Critically ill children aged 1 month to 5 years admitted to PICU at Assiut University Children Hospital
Key inclusion criteria (3 listed)
- Age from 1 month to 5 years
- Admitted to PICU with expected length of stay greater than 48 hours
- Written informed consent from parents or legal guardians
Key exclusion criteria (3 listed)
- Chronic renal or hepatic disease known to affect serum protein levels
- Incomplete medical records or discharged or transferred before first laboratory sample could be obtained
- Receiving nutritional support enteral or parenteral prior to PICU admission for condition unrelated to current critical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutritional status at PICU admission assessed by ABCD approach
Time frame: At baseline within 48 hours of admission
Number of children classified as malnourished based on comprehensive ABCD assessment including anthropometric measurements body mass index z-score mid-upper arm circumference skinfold thickness, biochemical markers albumin prealbumin total protein, clinical signs of muscle and fat loss, and dietary intake, obtained within 48 hours of PICU admission
4 secondary outcomes
Duration of mechanical ventilation
Time frame: Up to 30 days
Length of PICU stay
Time frame: Up to 30 days
PICU mortality
Time frame: Up to 30 days
Feeding intolerance and refeeding syndrome
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 32077997Tume LN, Valla FV, Joosten K, Jotterand Chaparro C, Latten L, Marino LV, Macleod I, Moullet C, Pathan N, Rooze S, van Rosmalen J, Verbruggen SCAT. Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations. Intensive Care Med. 2020 Mar;46(3):411-425. doi: 10.1007/s00134-019-05922-5. Epub 2020 Feb 20.
- Background: PubMed 35258497Hulst JM, Huysentruyt K, Gerasimidis K, Shamir R, Koletzko B, Chourdakis M, Fewtrell M, Joosten KF; Special Interest Group Clinical Malnutrition of ESPGHAN. A Practical Approach to Identifying Pediatric Disease-Associated Undernutrition: A Position Statement from the ESPGHAN Special Interest Group on Clinical Malnutrition. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):693-705. doi: 10.1097/MPG.0000000000003437. Epub 2022 Mar 3.
- Background: PubMed 37986053Abera EG, Sime H. The prevalence of malnutrition among critically ill children: a systematic review and meta-analysis. BMC Pediatr. 2023 Nov 21;23(1):583. doi: 10.1186/s12887-023-04419-x.
- Background: PubMed 40516325Agrawal A, Sharma S, Janjua D, Jadon G, Chanchlani R, Dsouza V. Impact of nutritional status on the mortality and clinical outcomes of children admitted to the pediatric intensive care unit: A systematic review and meta-analysis. Clin Nutr. 2025 Aug;51:28-39. doi: 10.1016/j.clnu.2025.06.002. Epub 2025 Jun 6.
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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.
Azza A Eltayeb, prof study chair
pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Critical Illness, 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merna A Felly, Resident (+20 15 51377917, mernafelly4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status at PICU admission assessed by ABCD approach (time frame: At baseline within 48 hours of admission). 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 NCT07830966, which also lists 4 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 22 Sep 2026.