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Completed

NCT Number: NCT07131098

Early Enteral Feeding and Clinical Outcomes in ICU Patients

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.

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Key information

Conditions

Critical Illness Disease Attributes Enteral Nutrition Feeding Protocol Intensive Care Unit ICU Nutritional Support Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jenin Governmental Hospital

Jenin, 00970, Palestinian Territories

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Length of ICU Stay (in days)

    Time frame: Through ICU discharge, up to 7 days

    Duration of patient stay in the intensive care unit, measured in full days from admission to discharge.

Secondary outcomes

  1. Glasgow Coma Scale (GCS) Score

    Time frame: Daily for up to 7 days.

    Assessment of neurological status using the GCS; higher scores indicate better consciousness levels.

  2. Hemoglobin Level (g/dL)

    Time frame: Day 1 and Day 7 of ICU stay

    Laboratory measure of hemoglobin concentration as an indicator of oxygen-carrying capacity and blood loss.

  3. Bicarbonate (HCO₃) Level (mEq/L)

    Time frame: Day 1 and Day 7 of ICU stay

    Blood bicarbonate levels used to assess acid-base balance in critically ill patients.

  4. Platelet Count (×10³/μL)

    Time frame: Day 1 and Day 7 of ICU stay

    Platelet concentration is measured from a complete blood count to evaluate clotting potential and bone marrow function.

  5. Calcium Level (mg/dL)

    Time frame: Day 1 and Day 7 of ICU stay

    Measurement of serum calcium levels to assess electrolyte balance and nutritional status.

  6. Mechanical Ventilation Duration (in days)

    Time frame: Through ICU discharge, up to 7 days

    Total number of days the patient required mechanical ventilation during ICU stay.

  7. Fraction of Inspired Oxygen (FiO₂) Requirement (%)

    Time frame: Daily for up to 7 days

    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.

  8. Positive End-Expiratory Pressure (PEEP) Requirement (cmH₂O)

    Time frame: Daily for up to 7 days

    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.

Sponsors and collaborators

Lead sponsor

Loai Muawiah Zabin

Other

Registry information

Official study title

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

Acronym: EEFP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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