Stepwise Enteral Nutritional Algorithm and Patient Outcomes in Pediatric Intensive Care Units

January 14, 2026 updated by: Ain Shams University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 11591
        • Recruiting
        • Ain Shams University
        • Contact:
        • Contact:
          • 01210366210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-implementation phase (Standard Care)
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.
Experimental: Post-implementation (Intervention)
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.
Other: Stepwise 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.
Other Names:
  • Standardized nutritional protocol
  • Enteral nutritional algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of admission until energy goals are reached, assessed up to 28 days.
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.
From date of admission up to 28 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Pediatric Intensive Care Unit stay
Time Frame: From date of admission assessed up to 28 days.
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.
From date of admission assessed up to 28 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

March 2, 2026

Study Completion (Estimated)

March 3, 2026

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

December 14, 2025

First Posted (Estimated)

December 29, 2025

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMASU MD331/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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