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Early Enteral Feeding and Clinical Outcomes in ICU Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07131098
Acronym
EEFP
Enrollment
80
Registered
2025-08-20
Start date
2024-01-01
Completion date
2024-04-30
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

OTHEREarly 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.

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.

Sponsors

Loai Muawiah Zabin
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

This was an open-label study. Neither the care providers nor the participants were blinded to the intervention assignment.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of ICU Stay (in days)Through ICU discharge, up to 7 daysDuration of patient stay in the intensive care unit, measured in full days from admission to discharge.

Secondary

MeasureTime frameDescription
Calcium Level (mg/dL)Day 1 and Day 7 of ICU stayMeasurement of serum calcium levels to assess electrolyte balance and nutritional status.
Glasgow Coma Scale (GCS) ScoreDaily for up to 7 days.Assessment of neurological status using the GCS; higher scores indicate better consciousness levels.
Hemoglobin Level (g/dL)Day 1 and Day 7 of ICU stayLaboratory measure of hemoglobin concentration as an indicator of oxygen-carrying capacity and blood loss.
Platelet Count (×10³/μL)Day 1 and Day 7 of ICU stayPlatelet concentration is measured from a complete blood count to evaluate clotting potential and bone marrow function.
Mechanical Ventilation Duration (in days)Through ICU discharge, up to 7 daysTotal number of days the patient required mechanical ventilation during ICU stay.
Fraction of Inspired Oxygen (FiO₂) Requirement (%)Daily for up to 7 daysDaily 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.
Positive End-Expiratory Pressure (PEEP) Requirement (cmH₂O)Daily for up to 7 daysDaily 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.
Bicarbonate (HCO₃) Level (mEq/L)Day 1 and Day 7 of ICU stayBlood bicarbonate levels used to assess acid-base balance in critically ill patients.

Countries

Palestinian Territories

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026