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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Mohamed A Mohamed, MSc, MB Bch contact

+201141141902

MohamedAkram@med.asu.edu.eg

Egypt1 site, 1 recruiting
  • Ain Shams University

    Cairo, Abbasia, 11591

    Mohamed Akram A Mohamed, MB BCh, MSc, +201141141902 ext. +201210366210, MohamedAkram@med.asu.edu.eg

    01210366210

    Recruiting

Other trials in Egypt

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.

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 groups in NCT07307027
Study groupRoleWhat they receive
Pre-implementation phase (Standard Care)No interventionThis 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)ExperimentalThis 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.

  1. 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.

  2. 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)
  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.

  1. First posted29 Dec 2025
  2. Study start1 Dec 2024
  3. Primary completion2 Mar 2026 (estimated)
  4. Study completion3 Mar 2026 (estimated)

Resources

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)
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

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.

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