Critical IllnessNCT07884838
Enteral Feeding in Mechanically Ventilated Children
An observational study of Critical Illness and Mechanical Ventilation Complication, run by Assiut University.
Trial summary
This prospective cohort study aims to assess enteral feeding practices and the adequacy of energy and protein delivery among mechanically ventilated children admitted to the pediatric intensive care unit. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Critical Illness, Mechanical Ventilation Complication
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2026to 10 Feb 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Mechanically ventilated children aged 1 month to 18 years admitted to the Pediatric Intensive Care Unit of Assiut University Children's Hospital.
Who may be able to join
- - Children aged 1 month to 18 years
- Admission to the PICU
- Requirement for invasive mechanical ventilation
- Expected PICU stay sufficient for assessment of nutritional delivery
- Written informed consent from parent or legal guardian
Who cannot join
- - Neonates under 1 month of age
- Absolute contraindication to enteral feeding
- Exclusive parenteral nutrition from admission
- Death or transfer within 48 hours of admission
- Inborn errors of metabolism needing special diets
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: Enteral Feeding Practices and Nutritional Adequacy in Mechanically Ventilated Children
This prospective cohort study aims to assess enteral feeding practices and the adequacy of energy and protein delivery among mechanically ventilated children admitted to the pediatric intensive care unit.
Read the detailed description
Children requiring invasive mechanical ventilation in the pediatric intensive care unit are at high risk of inadequate energy and protein intake. Enteral nutrition is preferred when the gastrointestinal tract is functional.
This observational study will prospectively evaluate the timing of initiation, adequacy of energy and protein delivery, feeding interruptions, and selected clinical outcomes in mechanically ventilated children admitted to the PICU at Assiut University Children's Hospital.
- Keywords
- Enteral nutrition, Nutritional adequacy, Pediatric intensive care, Mechanical ventilation, Assiut
- Medical subject headings
- 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 |
|---|---|---|
| Mechanically Ventilated Children | Children aged 1 month to 18 years requiring invasive mechanical ventilation in the PICU who will be followed for enteral feeding practices and nutritional adequacy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children achieving adequate energy delivery
Number of mechanically ventilated children who achieve predefined adequate energy delivery during the assessment period.
Measured: At 7 days
Secondary outcomes (4)
Energy adequacy percentage
Mean energy adequacy calculated as actual energy received divided by estimated energy requirement multiplied by 100.
Measured: At 7 days
Time to initiation of enteral feeding
Mean time in hours from PICU admission to initiation of enteral feeding.
Measured: At 7 days
Duration of mechanical ventilation
Mean duration of invasive mechanical ventilation in days.
Measured: At 28 days
PICU length of stay
Mean length of stay in the pediatric intensive care unit in days.
Measured: At 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion26 Oct 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Helal Marzouk Badros, Assiut University
- Investigators
- Ismail L Mohammed, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884838
- Sponsor's protocol ID
- EN-PICU-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Feeding Practices and Nutritional Adequacy in Mechanically Ventilated Children
- ClinicalTrials.gov ID
- NCT07884838
- Acronym / sponsor ID
- EN-PICU-Assiut-2026
- Keywords
- Enteral nutrition, Nutritional adequacy, Pediatric intensive care, Mechanical ventilation, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 26 Oct 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 21 Oct 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 enteral feeding practices and the adequacy of energy and protein delivery among mechanically ventilated children admitted to the pediatric intensive care unit.
Detailed description
Children requiring invasive mechanical ventilation in the pediatric intensive care unit are at high risk of inadequate energy and protein intake. Enteral nutrition is preferred when the gastrointestinal tract is functional.
This observational study will prospectively evaluate the timing of initiation, adequacy of energy and protein delivery, feeding interruptions, and selected clinical outcomes in mechanically ventilated children admitted to the PICU at Assiut University Children's Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically Ventilated Children | – | –Children aged 1 month to 18 years requiring invasive mechanical ventilation in the PICU who will be followed for enteral feeding practices and nutritional adequacy. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Mechanically ventilated children aged 1 month to 18 years admitted to the Pediatric Intensive Care Unit of Assiut University Children's Hospital.
Key inclusion criteria (5 listed)
- - Children aged 1 month to 18 years
- Admission to the PICU
- Requirement for invasive mechanical ventilation
- Expected PICU stay sufficient for assessment of nutritional delivery
- Written informed consent from parent or legal guardian
Key exclusion criteria (5 listed)
- - Neonates under 1 month of age
- Absolute contraindication to enteral feeding
- Exclusive parenteral nutrition from admission
- Death or transfer within 48 hours of admission
- Inborn errors of metabolism needing special diets
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
Number of children achieving adequate energy delivery
Time frame: At 7 days
Number of mechanically ventilated children who achieve predefined adequate energy delivery during the assessment period.
4 secondary outcomes
Energy adequacy percentage
Time frame: At 7 days
Time to initiation of enteral feeding
Time frame: At 7 days
Duration of mechanical ventilation
Time frame: At 28 days
PICU length of stay
Time frame: At 28 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 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Ismail L Mohammed, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Mechanical Ventilation Complication, 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 5 inclusion and 5 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 21 Oct 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 Marina H Marzouk, Resident (+20 12 11834760, marinahelal33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children achieving adequate energy delivery (time frame: At 7 days). 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 21 Oct 2026.