Early Enteral Feeding and Clinical Outcomes in ICU Patients (EEFP)

Effectiveness of an Early Enteral Feeding Protocol on Clinical Outcomes in Critically Ill Patients: A Quasi-experimental Study

This study evaluated the effectiveness of an early enteral feeding protocol in critically ill adult patients admitted to an Intensive Care Unit (ICU). The intervention involved initiating enteral nutrition within 24-48 hours of ICU admission. Clinical outcomes such as ICU length of stay, ventilator dependency, and selected laboratory values were compared between patients who received early enteral feeding and those who received standard nutritional care. The study was conducted at Jenin Governmental Hospital in Palestine between January and April 2024, with 80 adult participants.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Enteral Nutrition; Nutritional Support; Intensive Care Unit ICU; Feeding Protocol
• Intervention / Treatment: Other: Early Enteral Feeding Protocol; Other: Standard Nutritional Care

Detailed Description

This is a retrospectively registered, quasi-experimental study that investigated the clinical impact of implementing an early enteral feeding protocol in a critical care setting. Conducted in Jenin Governmental Hospital, Palestine, the research explored how protocolized early nutritional support affects physiological recovery and ICU-related outcomes in critically ill adult patients.

The study was motivated by the well-established role of early enteral nutrition in maintaining gut integrity, supporting immune function, and reducing complications in ICU patients. Despite international guidelines recommending its use within 24-48 hours of ICU admission, early enteral feeding remains underutilized in many low-resource healthcare settings. Factors contributing to this gap include variability in clinical practice, limited institutional protocols, and staff training constraints.

This investigation was carried out between January and April 2024 and followed rigorous ethical standards, with Institutional Review Board approval from Arab American University (Reference: R-2024/B/85/N). Patients were grouped based on the time period of admission into either a protocol-based early feeding group or a standard care group. Intervention fidelity was maintained through a pre-defined feeding protocol implemented by ICU staff after appropriate orientation and monitoring.

The study contributes to the growing body of evidence supporting structured nutritional protocols in ICUs and highlights the feasibility and benefits of such interventions in middle-income and resource-constrained settings. The data gathered and analyzed provide a foundation for future policy development aimed at standardizing nutritional support for critically ill patients.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Jenin, Palestinian Territory, occupied, 00970
    • Jenin governmental hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years and older
• Admitted to the ICU and eligible for enteral feeding
• Expected to stay in the ICU for more than 48 hours
• Able to initiate enteral feeding within 24-48 hours of ICU admission
• Informed consent obtained from the patient or legal guardian

Exclusion Criteria:

• Pregnant or lactating women
• Patients with gastrointestinal bleeding or obstruction
• Patients undergoing gastrointestinal surgery or with short bowel syndrome
• Diagnosed with COVID-19 during admission
• End-of-life care patients or those with do-not-resuscitate (DNR) orders
• Refusal to participate or withdrawal of consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Enteral Feeding Protocol; Participants in this group received early enteral nutrition initiated within 24-48 hours of ICU admission, based on a structured feeding protocol. The protocol followed international guidelines (ASPEN/ESPEN) and was implemented by ICU staff with training and monitoring support.	Other: Early Enteral Feeding Protocol; Early enteral nutrition was initiated within 24-48 hours of ICU admission based on a structured protocol aligned with ASPEN and ESPEN guidelines. The protocol defined target caloric goals, methods of tube feeding initiation, rate advancement, and monitoring procedures. Nurses and ICU staff were trained in protocol implementation. The goal was to optimize nutrition early in critical illness to improve clinical outcomes such as ICU length of stay, ventilator dependence, and physiological stability.
Other: Standard Nutritional Care; Participants in this group received standard ICU nutritional care without the implementation of the early enteral feeding protocol. Feeding initiation and type were left to physician discretion based on clinical judgment and routine hospital practices.	Other: Standard Nutritional Care; Patients in the control group received standard nutritional care per routine hospital practices. Initiation and progression of feeding were left to the discretion of the attending physician and nursing staff, without the use of a structured protocol or defined early feeding timeline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU Stay (in days)	Duration of patient stay in the intensive care unit, measured in full days from admission to discharge.	Through ICU discharge, up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Coma Scale (GCS) Score	Assessment of neurological status using the GCS; higher scores indicate better consciousness levels.	Daily for up to 7 days.
Hemoglobin Level (g/dL)	Laboratory measure of hemoglobin concentration as an indicator of oxygen-carrying capacity and blood loss.	Day 1 and Day 7 of ICU stay
Bicarbonate (HCO₃) Level (mEq/L)	Blood bicarbonate levels used to assess acid-base balance in critically ill patients.	Day 1 and Day 7 of ICU stay
Platelet Count (×10³/μL)	Platelet concentration is measured from a complete blood count to evaluate clotting potential and bone marrow function.	Day 1 and Day 7 of ICU stay
Calcium Level (mg/dL)	Measurement of serum calcium levels to assess electrolyte balance and nutritional status.	Day 1 and Day 7 of ICU stay
Mechanical Ventilation Duration (in days)	Total number of days the patient required mechanical ventilation during ICU stay.	Through ICU discharge, up to 7 days
Fraction of Inspired Oxygen (FiO₂) Requirement (%)	Daily measurement of the fraction of inspired oxygen (%) required by patients during mechanical ventilation in the ICU, used to assess respiratory support needs. Values will be recorded once daily and analyzed as mean values over the ICU stay.	Daily for up to 7 days
Positive End-Expiratory Pressure (PEEP) Requirement (cmH₂O)	Daily measurement of positive end-expiratory pressure (PEEP, in cmH₂O) applied during mechanical ventilation in the ICU, used to assess respiratory support needs. Values will be recorded once daily and analyzed as mean values over the ICU stay.	Daily for up to 7 days

Collaborators and Investigators

• Sponsor: Loai Muawiah Zabin
• Investigators: Study Chair: Sajed Ghawadra, PhD, Arab American University (Palestine); Principal Investigator: Hussein Mahameed, Master, Arab American University (Palestine)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: August 6, 2025
• First Submitted That Met QC Criteria: August 12, 2025
• First Posted (Actual): August 20, 2025

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Hemoglobin; Platelets; Sodium; Mechanical ventilation; Critically ill patients; Clinical outcomes; Bicarbonate; Nutritional therapy; Palestine; Quasi-experimental study; ICU nutrition; Length of ICU stay; Early enteral feeding; Protocol-based nutrition; Glasgow Coma Scale (GCS); Laboratory outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: AAUP-EEFP-ICU-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) collected during this study will not be shared publicly due to ethical and legal restrictions. The study involved critically ill patients in an intensive care setting, and data sharing was not included in the original informed consent or ethics approval. Ensuring patient confidentiality and privacy remains a top priority.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No