Pediatric Intensive Care UnitsNCT07041658
Nutritional Status of Critically Ill Children in Pediatric Intensive Care Units at Sohag University Hospitals
An observational study of Pediatric Intensive Care Units, run by Sohag University.
Trial summary
The goal of this observational study is to evaluate nutritional status of critically ill patients admitted to Pediatric Intensive Care Units (PICU) at Sohag University Hospital and its correlation with their outcome as regarding to need for mechanical ventilation, acquired infection, metabolic complications, and… Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Pediatric Intensive Care Units
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to May 2026
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: critically ill children who admitted in PICUs at Sohag University Hospital
Who may be able to join
- All critically ill children who admitted in PICUs at Sohag University Hospital with age range from 1 month up to 16 years old.
Who cannot join
- Patient with recurrent admissions to the PICU during the specified study period, only the first admission will be included.
- Patient with PICU stay less than 48 hours.
- Patients referred with nutritional regimen or metabolic disease e.g. patients on ketogenic diet and patients with inborn errors of metabolism.
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: Assessment of Nutritional Status of Critically Ill Children Admitted to Pediatric Intensive Care Units at Sohag University Hospitals
The goal of this observational study is to evaluate nutritional status of critically ill patients admitted to Pediatric Intensive Care Units (PICU) at Sohag University Hospital and its correlation with their outcome as regarding to need for mechanical ventilation, acquired infection, metabolic complications, and mortality.
Read the detailed description
Nutrition is one of the important factors which affect morbidity and mortality in critically ill patients in pediatric intensive care units (PICU). Adequate and balanced nutrition is required not only to support physical growth and basic metabolic needs, but also to ensure proper organ function and sustain daily activities.
Nutritional status reflects the dynamic balance between nutrient availability, dietary intake, and the body's ability to absorb and utilize those nutrients in relation to an individual's specific needs.
Critical illness triggers significant metabolic and endocrine changes which are characterized by catabolism, insulin resistance, stress hyperglycemia and shifts in substrate utilization. These changes closely interact with disruptions in the autonomic and immune systems. Critically ill infants and children may have an increased metabolic need, which predisposes them to nutritional deterioration and malnutrition during illness.
The World Health Organization (WHO) defines malnutrition as " an acute or chronic nutritional status due to deficiency or excess energy, protein and micronutrient resulting in imbalance between nutrient intake and requirement that can negatively affect growth and development".
Malnutrition in critically ill patients is associated with decreased respiratory function, higher rate of nosocomial infections, secondary immunodeficiency, prolonged mechanical ventilation and prolonged hospitalization. It is also related to delayed wound healing process, impairment in gastrointestinal functions, thus increased morbidity and mortality.
The American and European Society of Parenteral and Enteral Nutrition guidelines recommend that nutritional status should be evaluated on admission to the PICU to identify children at risk and to provide nutrition support in the PICU.
Enteral feeding approach has been preferred to be started within the first 24-48 hours after admission to the PICU, if there are no contraindications for enteral nutrition. Early initiation of enteral feeding have been associated with improved clinical outcomes as regard morbidity and mortality. Metabolic demands must be determined by calculating energy consumption.
Malnutrition at PICU admission is frequent (15-25% prevalence rates) in developing countries. A study published in 2022 on the nutritional status of critically ill children in one Egyptian PICU found that malnutrition rate can be around 30%. However, the data on nutritional status in Egyptian PICUs is scarce especially in Upper Egypt. Therefore, assessment of nutritional status in our PICU can help in improving the outcome of critically ill children in terms of both morbidity and mortality.
- Conditions
- Pediatric Intensive Care Units
What is being measured
The primary outcome is the main question the study is designed to answer.
need for mechanical ventilation
Measured: one week following PICU admission
acquired infection
Measured: one week following PICU admission
mortality
Measured: one week following PICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Intensive Care UnitsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klara Boulis Anwar, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041658
- Sponsor's protocol ID
- Soh-Med-25-5--3MD
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutritional Status of Critically Ill Children Admitted to Pediatric Intensive Care Units at Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT07041658
- Acronym / sponsor ID
- Soh-Med-25-5--3MD
- Conditions
- Pediatric Intensive Care Units
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
The goal of this observational study is to evaluate nutritional status of critically ill patients admitted to Pediatric Intensive Care Units (PICU) at Sohag University Hospital and its correlation with their outcome as regarding to need for mechanical ventilation, acquired infection, metabolic complications, and mortality.
Detailed description
Nutrition is one of the important factors which affect morbidity and mortality in critically ill patients in pediatric intensive care units (PICU). Adequate and balanced nutrition is required not only to support physical growth and basic metabolic needs, but also to ensure proper organ function and sustain daily activities.
Nutritional status reflects the dynamic balance between nutrient availability, dietary intake, and the body's ability to absorb and utilize those nutrients in relation to an individual's specific needs.
Critical illness triggers significant metabolic and endocrine changes which are characterized by catabolism, insulin resistance, stress hyperglycemia and shifts in substrate utilization. These changes closely interact with disruptions in the autonomic and immune systems. Critically ill infants and children may have an increased metabolic need, which predisposes them to nutritional deterioration and malnutrition during illness.
The World Health Organization (WHO) defines malnutrition as " an acute or chronic nutritional status due to deficiency or excess energy, protein and micronutrient resulting in imbalance between nutrient intake and requirement that can negatively affect growth and development".
Malnutrition in critically ill patients is associated with decreased respiratory function, higher rate of nosocomial infections, secondary immunodeficiency, prolonged mechanical ventilation and prolonged hospitalization. It is also related to delayed wound healing process, impairment in gastrointestinal functions, thus increased morbidity and mortality.
The American and European Society of Parenteral and Enteral Nutrition guidelines recommend that nutritional status should be evaluated on admission to the PICU to identify children at risk and to provide nutrition support in the PICU.
Enteral feeding approach has been preferred to be started within the first 24-48 hours after admission to the PICU, if there are no contraindications for enteral nutrition. Early initiation of enteral feeding have been associated with improved clinical outcomes as regard morbidity and mortality. Metabolic demands must be determined by calculating energy consumption.
Malnutrition at PICU admission is frequent (15-25% prevalence rates) in developing countries. A study published in 2022 on the nutritional status of critically ill children in one Egyptian PICU found that malnutrition rate can be around 30%. However, the data on nutritional status in Egyptian PICUs is scarce especially in Upper Egypt. Therefore, assessment of nutritional status in our PICU can help in improving the outcome of critically ill children in terms of both morbidity and mortality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- critically ill children who admitted in PICUs at Sohag University Hospital
Key inclusion criteria (1 listed)
- All critically ill children who admitted in PICUs at Sohag University Hospital with age range from 1 month up to 16 years old.
Key exclusion criteria (3 listed)
- Patient with recurrent admissions to the PICU during the specified study period, only the first admission will be included.
- Patient with PICU stay less than 48 hours.
- Patients referred with nutritional regimen or metabolic disease e.g. patients on ketogenic diet and patients with inborn errors of metabolism.
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
need for mechanical ventilation
Time frame: one week following PICU admission
acquired infection
Time frame: one week following PICU admission
mortality
Time frame: one week following PICU admission
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 27 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Intensive Care Units, run by Sohag 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 1 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 27 Jun 2025. 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 Klara Boles Anwer, MD (01093356294, Klara_boulis@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
need for mechanical ventilation (time frame: one week following PICU admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2025.