Enteral NutritionNCT07307027
Stepwise Enteral Nutritional Algorithm and Patient Outcomes in Pediatric Intensive Care Units
A study testing Stepwise Enteral Nutritional Algorithm in people with Enteral Nutrition and Enteral Nutrition Feeding, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study to evaluate the effectiveness and patient's outcome after implementing enteral nutrition algorithm designed to achieve optimal enteral nutrition delivery in the pediatric intensive care unit and to evaluate the effect of implementing this protocol on critically ill patient's individual's outcome. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Enteral Nutrition, Enteral Nutrition Feeding, Enteral Nutrition Intolerance in Critically Ill Patients
- What is being tested?
- Stepwise Enteral Nutritional Algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 3 Mar 2026
- Phase
- Interventional
- 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
Who may be able to join
- Critically ill infants and children admitted to the Pediatric Intensive Care Units.
- Age range from 1 month to 16 years (specifically males up to 14 years and females up to 16 years).
Who cannot join
- Patients who are discharged or died within 24 hours of admission.
- Patients with acute pancreatitis.
- Patients with esophageal perforation.
- Patients with a known metabolic disorder.
- Patients requiring a ketogenic diet.
- Patients with Short Bowel Syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Abbasia, 11591
Mohamed Akram A Mohamed, MB BCh, MSc, +201141141902 ext. +201210366210, MohamedAkram@med.asu.edu.eg
01210366210
About this study
Official title: Could a Stepwise Enteral Nutritional Algorithm Affect Patient's Outcome in Pediatric Intensive Care Units? An Interventional Study
The aim of the study to evaluate the effectiveness and patient's outcome after implementing enteral nutrition algorithm designed to achieve optimal enteral nutrition delivery in the pediatric intensive care unit and to evaluate the effect of implementing this protocol on critically ill patient's individual's outcome.
Read the detailed description
The aim of the study to evaluate the effectiveness and patient's outcome after implementing enteral nutrition algorithm designed to achieve optimal enteral nutrition delivery in the pediatric intensive care unit and to evaluate the effect of implementing this protocol on critically ill patient's individual's outcome. Critically ill children in Pediatric Intensive Care Units (PICUs) are particularly vulnerable to malnutrition due to limited body reserves, high metabolic stress, and the catabolic nature of critical illness. While Enteral Nutrition (EN) is the preferred method of nutrient delivery, its optimal implementation is frequently hindered by avoidable barriers and interruptions, such as prolonged fasting for procedures or conservative management of gastrointestinal intolerance. Delays in initiating and advancing EN are associated with failure to reach energy goals and poorer clinical outcomes. This study hypothesizes that implementing a uniform, stepwise nutritional algorithm will decrease avoidable EN interruptions, optimize nutrient delivery, and improve patient outcomes.
Study Design and Methods: This is a prospective, interventional study utilizing a pre/post-implementation design to evaluate the efficacy of a standardized feeding protocol. The study will be conducted at the Pediatric Intensive Care Units of Ain Shams University Children's Hospital.
The study is divided into two distinct phases:
Pre-implementation Phase: Baseline data will be collected on 40 consecutively recruited patients managed under the unit's standard care practices without the specific algorithm.
Post-implementation Phase: A new, stepwise nutritional algorithm will be implemented for a subsequent cohort of 40 patients.
The Intervention (Stepwise Nutritional Algorithm): The intervention involves a structured protocol for nutritional assessment, feeding initiation, advancement, and management of intolerance.
Key components of the algorithm include:
Nutritional Assessment: All patients undergo anthropometric assessment (weight, height/length, MUAC) and screening using the STRONGkids tool and WHO/CDC growth charts upon admission.
Caloric Targets: Energy requirements are calculated using WHO guidelines or the Schofield equation (for sedated/ventilated patients), and protein goals are set based on ASPEN guidelines (ranging from 1.5 to 3 g/kg/day depending on age).
Initiation of Feeding: Enteral feeding is to be initiated within 4 hours of admission absent contraindications (e.g., hemodynamic instability, bowel obstruction).
Feeding Strategy:
Infants <1 year: Expressed breast milk is the preferred first line; if unavailable, standard infant formula is used.
Advancement: Feeding typically starts at 20 ml/kg/day divided every 3 hours. If tolerated, it is advanced by 2 ml/kg/feed every 3 hours until target goals are met.
Management of Intolerance: The protocol provides specific definitions and management steps for intolerance symptoms:
Emesis: Defined as ≥2 episodes/24 hrs. Diarrhea: Defined as >3 episodes of loose stool/24 hrs. Abdominal Distention: Defined as an increase in abdominal girth by >2 cm from baseline for 2 consecutive feds.
Procedural Fasting: The algorithm standardizes fasting times (NPO) prior to procedures to minimize unnecessary interruptions (e.g., 4 hours for elective intubation, 6 hours for surgical procedures under GA).
Data Collection and Comparison: Outcomes will be compared between the pre-implementation and post-implementation cohorts.
Data collection includes:
Nutritional Metrics: Time from admission to EN initiation, time to reach target energy goals, and the frequency and duration of EN interruptions.
Clinical Outcomes: Duration of mechanical ventilation, length of PICU stay, and patient survival/mortality.
Safety: Incidence of feeding intolerance (vomiting, diarrhea, distention) and aspiration risks.
Statistical Analysis: Data will be analyzed using SPSS version 23. Quantitative data will be compared using Student's T-test or Mann-Whitney tests, while qualitative data will be analyzed using Chi-square or Fisher's exact tests. A p-value of ≤0.05 will be considered statistically significant.
- Conditions
- Enteral Nutrition, Enteral Nutrition Feeding, Enteral Nutrition Intolerance in Critically Ill Patients
- Being tested
- Stepwise Enteral Nutritional Algorithm
- Keywords
- enteral nutrition in critically ill, EN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepwise Enteral Nutritional AlgorithmOther
Also called Standardized nutritional protocol, Enteral nutritional algorithm
A standardized, stepwise protocol for the initiation, advancement, and maintenance of enteral nutrition in critically ill children. It includes specific guidelines for caloric targets, managing feeding intolerance (vomiting, diarrhea, distention), and standardized fasting times for procedures to minimize interruptions.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation phase (Standard Care) | No intervention | This group consists of 40 patients recruited consecutively before the introduction of the new nutritional algorithm. Patients in this arm receive the standard nutritional care practices currently used in the Pediatric Intensive Care Unit without the standardized stepwise protocol. |
| Post-implementation (Intervention) | Experimental | This group consists of 40 patients recruited after the implementation of the standardized stepwise Enteral Nutritional (EN) algorithm. Patients in this arm are managed according to the specific guidelines for feeding initiation, advancement, and intolerance management defined in the study protocol. Receives: Other: Stepwise Enteral Nutritional Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach target energy goals
The duration (measured in days) required for the patient to achieve 100% of their calculated daily caloric target via enteral nutrition. Caloric targets are determined using FAO/WHO/UNU estimated energy requirements or the Schofield equation for sedated/ventilated patients.
Measured: From date of admission until energy goals are reached, assessed up to 28 days.
Number of enteral nutrition interruptions
The total count of episodes where enteral feeding was temporarily or permanently stopped. An interruption is defined as the cessation of feeding for reasons such as hemodynamic instability, medical procedures, or aspiration risk.
Measured: From date of admission up to 28 days.
Secondary outcomes (1)
Length of Pediatric Intensive Care Unit stay
The total duration (in days) a patient remains in the PICU from admission to discharge. This measure is compared between the pre-implementation and post-implementation groups to evaluate if the stepwise nutritional algorithm reduces the length of stay.
Measured: From date of admission assessed up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Dec 2024
- Primary completion2 Mar 2026 (estimated)
- Study completion3 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a quasi-experimental pre-post implementation study. Participants are recruited sequentially in two phases: a baseline "pre-implementation" cohort managed with standard care, followed by a "post-implementation" cohort managed using the new stepwise enteral nutritional algorithm.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307027
- Sponsor's protocol ID
- FMASU MD331/2024
- Status last verified
- Jan 2026
- First submitted
- 14 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could a Stepwise Enteral Nutritional Algorithm Affect Patient's Outcome in Pediatric Intensive Care Units? An Interventional Study
- ClinicalTrials.gov ID
- NCT07307027
- Acronym / sponsor ID
- FMASU MD331/2024
- Conditions
- Enteral Nutrition, Enteral Nutrition Feeding, Enteral Nutrition Intolerance in Critically Ill Patients
- Keywords
- enteral nutrition in critically ill, EN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 3 Mar 2026 (estimated)
- First posted
- 29 Dec 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 aim of the study to evaluate the effectiveness and patient's outcome after implementing enteral nutrition algorithm designed to achieve optimal enteral nutrition delivery in the pediatric intensive care unit and to evaluate the effect of implementing this protocol on critically ill patient's individual's outcome.
Detailed description
The aim of the study to evaluate the effectiveness and patient's outcome after implementing enteral nutrition algorithm designed to achieve optimal enteral nutrition delivery in the pediatric intensive care unit and to evaluate the effect of implementing this protocol on critically ill patient's individual's outcome. Critically ill children in Pediatric Intensive Care Units (PICUs) are particularly vulnerable to malnutrition due to limited body reserves, high metabolic stress, and the catabolic nature of critical illness. While Enteral Nutrition (EN) is the preferred method of nutrient delivery, its optimal implementation is frequently hindered by avoidable barriers and interruptions, such as prolonged fasting for procedures or conservative management of gastrointestinal intolerance. Delays in initiating and advancing EN are associated with failure to reach energy goals and poorer clinical outcomes. This study hypothesizes that implementing a uniform, stepwise nutritional algorithm will decrease avoidable EN interruptions, optimize nutrient delivery, and improve patient outcomes.
Study Design and Methods: This is a prospective, interventional study utilizing a pre/post-implementation design to evaluate the efficacy of a standardized feeding protocol. The study will be conducted at the Pediatric Intensive Care Units of Ain Shams University Children's Hospital.
The study is divided into two distinct phases:
Pre-implementation Phase: Baseline data will be collected on 40 consecutively recruited patients managed under the unit's standard care practices without the specific algorithm.
Post-implementation Phase: A new, stepwise nutritional algorithm will be implemented for a subsequent cohort of 40 patients.
The Intervention (Stepwise Nutritional Algorithm): The intervention involves a structured protocol for nutritional assessment, feeding initiation, advancement, and management of intolerance.
Key components of the algorithm include:
Nutritional Assessment: All patients undergo anthropometric assessment (weight, height/length, MUAC) and screening using the STRONGkids tool and WHO/CDC growth charts upon admission.
Caloric Targets: Energy requirements are calculated using WHO guidelines or the Schofield equation (for sedated/ventilated patients), and protein goals are set based on ASPEN guidelines (ranging from 1.5 to 3 g/kg/day depending on age).
Initiation of Feeding: Enteral feeding is to be initiated within 4 hours of admission absent contraindications (e.g., hemodynamic instability, bowel obstruction).
Feeding Strategy:
Infants <1 year: Expressed breast milk is the preferred first line; if unavailable, standard infant formula is used.
Advancement: Feeding typically starts at 20 ml/kg/day divided every 3 hours. If tolerated, it is advanced by 2 ml/kg/feed every 3 hours until target goals are met.
Management of Intolerance: The protocol provides specific definitions and management steps for intolerance symptoms:
Emesis: Defined as ≥2 episodes/24 hrs. Diarrhea: Defined as >3 episodes of loose stool/24 hrs. Abdominal Distention: Defined as an increase in abdominal girth by >2 cm from baseline for 2 consecutive feds.
Procedural Fasting: The algorithm standardizes fasting times (NPO) prior to procedures to minimize unnecessary interruptions (e.g., 4 hours for elective intubation, 6 hours for surgical procedures under GA).
Data Collection and Comparison: Outcomes will be compared between the pre-implementation and post-implementation cohorts.
Data collection includes:
Nutritional Metrics: Time from admission to EN initiation, time to reach target energy goals, and the frequency and duration of EN interruptions.
Clinical Outcomes: Duration of mechanical ventilation, length of PICU stay, and patient survival/mortality.
Safety: Incidence of feeding intolerance (vomiting, diarrhea, distention) and aspiration risks.
Statistical Analysis: Data will be analyzed using SPSS version 23. Quantitative data will be compared using Student's T-test or Mann-Whitney tests, while qualitative data will be analyzed using Chi-square or Fisher's exact tests. A p-value of ≤0.05 will be considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a quasi-experimental pre-post implementation study. Participants are recruited sequentially in two phases: a baseline "pre-implementation" cohort managed with standard care, followed by a "post-implementation" cohort managed using the new stepwise enteral nutritional algorithm.
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation phase (Standard Care) | No intervention | –This group consists of 40 patients recruited consecutively before the introduction of the new nutritional algorithm. Patients in this arm receive the standard nutritional care practices currently used in the Pediatric Intensive Care Unit without the standardized stepwise protocol. |
| Post-implementation (Intervention) | Experimental | Other: Stepwise Enteral Nutritional AlgorithmThis group consists of 40 patients recruited after the implementation of the standardized stepwise Enteral Nutritional (EN) algorithm. Patients in this arm are managed according to the specific guidelines for feeding initiation, advancement, and intolerance management defined in the study protocol. |
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Critically ill infants and children admitted to the Pediatric Intensive Care Units.
- Age range from 1 month to 16 years (specifically males up to 14 years and females up to 16 years).
Key exclusion criteria (6 listed)
- Patients who are discharged or died within 24 hours of admission.
- Patients with acute pancreatitis.
- Patients with esophageal perforation.
- Patients with a known metabolic disorder.
- Patients requiring a ketogenic diet.
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 |
|---|---|---|
| Stepwise Enteral Nutritional AlgorithmAlso: Standardized nutritional protocol, Enteral nutritional algorithmA standardized, stepwise protocol for the initiation, advancement, and maintenance of enteral nutrition in critically ill children. It includes specific guidelines for caloric targets, managing feeding intolerance (vomiting, diarrhea, distention), and standardized fasting times for procedures to minimize interruptions. | Other | Post-implementation (Intervention) |
Primary outcome
Time to reach target energy goals
Time frame: From date of admission until energy goals are reached, assessed up to 28 days.
The duration (measured in days) required for the patient to achieve 100% of their calculated daily caloric target via enteral nutrition. Caloric targets are determined using FAO/WHO/UNU estimated energy requirements or the Schofield equation for sedated/ventilated patients.
Number of enteral nutrition interruptions
Time frame: From date of admission up to 28 days.
The total count of episodes where enteral feeding was temporarily or permanently stopped. An interruption is defined as the cessation of feeding for reasons such as hemodynamic instability, medical procedures, or aspiration risk.
1 secondary outcome
Length of Pediatric Intensive Care Unit stay
Time frame: From date of admission assessed up to 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 16 Jan 2026.
- Individual participant dataSharing planned: No. No plan to share
Related trials for Enteral Nutrition
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
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High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
Extreme Prematurity, Enteral Nutrition
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Gut Microbiota Changes in Children Receiving Exclusive Enteral Nutrition With Compleat® Paediatric
Feeding and Eating Disorders of Childhood, Enteral Nutrition Dependence
Not yet recruitingObservational study
Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients
Percutaneous Endoscopic Gastrostomy, Enteral Nutrition Feeding
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Association of Biomarkers and Gastric Antral Motility Index With Feeding Intolerance in Critically Ill Patients
Critically Ill Patients Who Are Not Allowed to Eat Orally But Can Initiate Enteral Nutrition Within 48 Hours of ICU
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepwise Enteral Nutritional Algorithm in people with Enteral Nutrition and Enteral Nutrition Feeding, run by Ain Shams University at 1 site in Egypt.
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 6 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mohamed A Mohamed, MSc, MB Bch (+201141141902, MohamedAkram@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach target energy goals (time frame: From date of admission until energy goals are reached, assessed up to 28 days.). The study lists 2 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 16 Jan 2026; AzTrials last refreshed its copy on 2 Nov 2026.