Could a Stepwise Enteral Nutritional Algorithm Affect Patient's Outcome in Pediatric Intensive Care Units? An Interventional Study
NCT ID: NCT07307027
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-12-01
2025-12-25
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age range from 1 month to 16 years (specifically males up to 14 years and females up to 16 years).
Exclusion Criteria
* Patients with acute pancreatitis.
* Patients with esophageal perforation.
* Patients with a known metabolic disorder.
* Patients requiring a ketogenic diet.
* Patients with Short Bowel Syndrome.
1 Month
16 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Locations
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Ain Shams University
Cairo, Abbasia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Mohamed Akram A Mohamed, MB BCh, MSc
Role: primary
01210366210
Role: backup
Other Identifiers
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FMASU MD331/2024
Identifier Type: -
Identifier Source: org_study_id