An interventional study of Early Enteral Feeding Protocol and Standard Nutritional Care in Critical Illness, Enteral Nutrition and Intensive Care Unit ICU, sponsored by Loai Muawiah Zabin. Completed at 1 site in Palestinian Territories. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Loai Muawiah Zabin · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 80 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
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
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
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.
Length of ICU Stay (in days)
Duration of patient stay in the intensive care unit, measured in full days from admission to discharge.
Time frame: Through ICU discharge, up to 7 days
Glasgow Coma Scale (GCS) Score
Assessment of neurological status using the GCS; higher scores indicate better consciousness levels.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 and Day 7 of ICU stay
Calcium Level (mg/dL)
Measurement of serum calcium levels to assess electrolyte balance and nutritional status.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Daily for up to 7 days
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Loai Muawiah Zabin