Critical IllnessEEFPNCT07131098
Early Enteral Feeding and Clinical Outcomes in ICU Patients
A study testing Early Enteral Feeding Protocol and Standard Nutritional Care in people with Critical Illness and Enteral Nutrition, run by Loai Muawiah Zabin at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Enteral Nutrition, Intensive Care Unit ICU
- What is being tested?
- Early Enteral Feeding Protocol and Standard Nutritional Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Jan 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Jenin Governmental Hospital
Jenin, 00970
About this study
Official title: Effectiveness of an Early Enteral Feeding Protocol on Clinical Outcomes in Critically Ill Patients: A Quasi-experimental Study
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.
Read the 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
- Being tested
- Early Enteral Feeding Protocol, Standard Nutritional Care
- 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
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Enteral Feeding ProtocolOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Nutritional Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ICU Stay (in days)
Duration of patient stay in the intensive care unit, measured in full days from admission to discharge.
Measured: Through ICU discharge, up to 7 days
Secondary outcomes (8)
Glasgow Coma Scale (GCS) Score
Assessment of neurological status using the GCS; higher scores indicate better consciousness levels.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 and Day 7 of ICU stay
Calcium Level (mg/dL)
Measurement of serum calcium levels to assess electrolyte balance and nutritional status.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily for up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loai Muawiah Zabin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Loai Muawiah Zabin, Arab American University (Palestine)
- Investigators
- Hussein Mahameed, Master, Principal investigator, Arab American University (Palestine)Sajed Ghawadra, PhD, Study chair, Arab American University (Palestine)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131098
- Sponsor's protocol ID
- AAUP-EEFP-ICU-2024
- Acronym
- EEFP
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Early Enteral Feeding Protocol on Clinical Outcomes in Critically Ill Patients: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07131098
- Acronym / sponsor ID
- EEFP / AAUP-EEFP-ICU-2024
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Loai Muawiah ZabinUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Enteral Feeding Protocol | Experimental | Other: Early Enteral Feeding ProtocolParticipants 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. |
| Standard Nutritional Care | Other | Other: Standard Nutritional CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Enteral Feeding ProtocolEarly 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. | Other | Early Enteral Feeding Protocol |
| Standard Nutritional CarePatients 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. | Other | Standard Nutritional Care |
Primary outcome
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.
8 secondary outcomes
Glasgow Coma Scale (GCS) Score
Time frame: Daily for up to 7 days.
Hemoglobin Level (g/dL)
Time frame: Day 1 and Day 7 of ICU stay
Bicarbonate (HCO₃) Level (mEq/L)
Time frame: Day 1 and Day 7 of ICU stay
Platelet Count (×10³/μL)
Time frame: Day 1 and Day 7 of ICU stay
Calcium Level (mg/dL)
Time frame: Day 1 and Day 7 of ICU stay
Mechanical Ventilation Duration (in days)
Time frame: Through ICU discharge, up to 7 days
Fraction of Inspired Oxygen (FiO₂) Requirement (%)
Time frame: Daily for up to 7 days
Positive End-Expiratory Pressure (PEEP) Requirement (cmH₂O)
Time frame: Daily for up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussein Mahameed, Master principal investigator
Arab American University (Palestine)
Sajed Ghawadra, PhD study chair
Arab American University (Palestine)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Enteral Feeding Protocol and Standard Nutritional Care in people with Critical Illness and Enteral Nutrition, run by Loai Muawiah Zabin at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of ICU Stay (in days) (time frame: Through ICU discharge, up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.