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

NCT07307027 | Recruiting

• 1 other identifier: FMASU MD331/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enteral Nutrition; Enteral Nutrition Feeding; Enteral Nutrition Intolerance in Critically Ill Patients

Keywords

enteral nutrition in critically ill; EN

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From date of admission up to 28 days.

Secondary Outcomes (1)

• Length of Pediatric Intensive Care Unit stay

  From date of admission assessed up to 28 days.

Study Arms (2)

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.

Other: Stepwise Enteral Nutritional Algorithm

Interventions

Stepwise Enteral Nutritional Algorithm OTHER

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.

Also known as: Standardized nutritional protocol, Enteral nutritional algorithm

Post-implementation (Intervention)

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, 11591, Egypt

RECRUITING

Central Study Contacts

Mohamed A Mohamed, MSc, MB Bch

CONTACT

+201141141902; MohamedAkram@med.asu.edu.eg

Mervat G Mervat, MD

CONTACT

+201000837437; Muhammedakrammed@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, care providers, and investigators are aware of the assigned intervention (standard care vs. nutritional algorithm) due to the nature of the feeding protocol implementation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: December 1, 2024
• Primary Completion: March 2, 2026
• Study Completion: March 3, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)