Early Enteral Feeding and Clinical Outcomes in ICU Patients

NCT ID: NCT07131098

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-04-30

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.

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Early Enteral Feeding Protocol

Intervention Type: 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.

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.

Group Type: OTHER

Standard Nutritional Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loai Muawiah Zabin

OTHER

Sponsor Role: lead

Responsible Party

Loai Muawiah Zabin

Faculty Member, Arab American University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hussein Mahameed, Master

Role: PRINCIPAL_INVESTIGATOR

Arab American University (Palestine)

Sajed Ghawadra, PhD

Role: STUDY_CHAIR

Arab American University (Palestine)

Locations

Jenin Governmental Hospital

Jenin, , Palestinian Territories

Countries

Palestinian Territories

Other Identifiers

AAUP-EEFP-ICU-2024

Identifier Type: -

Identifier Source: org_study_id