NCT07307027

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

Could a Stepwise Enteral Nutritional Algorithm Affect Patient's Outcome in Pediatric Intensive Care Units? An Interventional Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 1 Month – 16 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-03-02
• Completion: 2026-03-03
• First posted: 2025-12-29
• Last updated: 2026-01-16

Locations

1 site across 1 country: Egypt