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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of admission assessed up to 28 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed A Mohamed, MSc, MB Bch | Contact | +201141141902 | MohamedAkram@med.asu.edu.eg | |
| Mervat G Mervat, MD | Contact | +201000837437 | Muhammedakrammed@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | Abbasia | 11591 | Egypt |
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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.
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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.
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