Could a Stepwise Enteral Nutritional Algorithm Affect Patient's Outcome in Pediatric Intensive Care Units? An Interventional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Time to reach target energy goals
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
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.
Eligibility Criteria
- Ages
- 1 Month to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Length of Pediatric Intensive Care Unit stay(From date of admission assessed up to 28 days.)