Early Enteral Feeding and Clinical Outcomes in ICU Patients

NCT07131098 | Completed

• 1 other identifier: AAUP-EEFP-ICU-2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Enteral Nutrition; Intensive Care Unit ICU; Nutritional Support; Feeding Protocol

Keywords

Early enteral feeding; ICU nutrition; Critically ill patients; Quasi-experimental study; Palestine; Protocol-based nutrition; Clinical outcomes; Nutritional therapy; Mechanical ventilation; Length of ICU stay; Glasgow Coma Scale (GCS); Laboratory outcomes; Bicarbonate; Sodium; Platelets; Hemoglobin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Glasgow Coma Scale (GCS) Score

  Daily for up to 7 days.

• Hemoglobin Level (g/dL)

  Day 1 and Day 7 of ICU stay

• Bicarbonate (HCO₃) Level (mEq/L)

  Day 1 and Day 7 of ICU stay

• Platelet Count (×10³/μL)

  Day 1 and Day 7 of ICU stay

• Calcium Level (mg/dL)

  Day 1 and Day 7 of ICU stay

Study Arms (2)

Early Enteral Feeding Protocol

EXPERIMENTAL

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

Standard Nutritional Care

OTHER

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

Interventions

Early Enteral Feeding Protocol OTHER

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.

Early Enteral Feeding Protocol

Standard Nutritional Care OTHER

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.

Standard Nutritional Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loai Muawiah Zabin: lead

Study Sites (1)

Jenin Governmental Hospital

Jenin, 00970, Palestinian Territories

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hussein Mahameed, Master

  Arab American University (Palestine)

  PRINCIPAL INVESTIGATOR

• Sajed Ghawadra, PhD

  Arab American University (Palestine)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study. Neither the care providers nor the participants were blinded to the intervention assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty Member, Arab American University

Model Details: Participants were assigned to either an experimental group, receiving early enteral feeding per a structured protocol, or a control group, receiving standard nutritional care. Grouping was based on period of admission to minimize selection bias.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 20, 2025
• Study Start: January 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)