Aspiration PneumoniaPhase 4TPNNCT06395740
Aspiration Pneumonia in Cerebrovascular Stroke Patients Suffering From Bulbar Palsy
A Phase 4 study testing Enteral nutrtion and TPN in people with Aspiration Pneumonia, run by Ain Shams University at 1 site in Egypt.
Trial summary
One of the most serious complications in the critically ill patient complaining of bulbar palsy is aspiration pneumonia. These patients are scheduled for nasogastric tube feeding trying to avoid recurrent aspiration and subsequent aspiration pneumonia. Even though, the risk of aspiration is still present. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration Pneumonia
- What is being tested?
- Enteral nutrtion and TPN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2024to 30 Mar 2026
- Phase
- Phase 4
- 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
- 1. cerebrovascular stroke patients either ischemic or haemorrhagic within first 7 days 2. Age above 18 years 3. patients suffering from bulbar palsy.
Who cannot join
- Mechanically ventilated patients at first presentation. 2. Patients suffering from attacks of fits. 3. Patients suffering from signs and symptoms of pneumonia before attack of cerebrovascular stroke.
- 4. Patients suffering from degenerative neurological diseases. 5. Patients with developmental delay or neurological disease. 6. Patients with hepatic or renal coma. 7. Patients with hemodynamic instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Incidence of Pneumonia in Non-ventilated Cerebrovascular Stroke Patients Suffering From Bulbar Palsy Depending on Nasogastric Tube Feeding and Those Who Are Totally Parenterally Fed.
One of the most serious complications in the critically ill patient complaining of bulbar palsy is aspiration pneumonia. These patients are scheduled for nasogastric tube feeding trying to avoid recurrent aspiration and subsequent aspiration pneumonia. Even though, the risk of aspiration is still present. Putting a total parenteral nutrition regimen for these patients is a supposed strategy to avoid aspiration pneumonia till recovery from bulbar palsy or planning for tracheostomy and or feeding gastrostomy.
Read the detailed description
Aspiration pneumonia in cerebrovascular patients suffering from bulbar palsy can reach up to 60 %. (Martino R et al., 2012). All swallowing stages can be affected in cerebrovascular stroke patients. Difficulty in deglutition lower oesophageal sphincter dysfunction, delayed gastric empty and subsequent increase in gastric residual volume and decreased lower oesophageal sphincter tone and subsequent increase in gastroesophageal reflux all can be found in patients suffering from cerebrovascular stroke. (Schaller BJ et al., 2006).
As enteral feeding via oral route is risky in patients suffering from bulbar palsy, nasogastric tube is being used as a mode of enteral feeding till recovery from bulbar palsy or doing a gastrostomy tube as an alternative mode for enteral feeding. There is no survival benefit for early enteral feeding via nasogastric tube when compared with delayed tube feeding as formulated by the Feed or Ordinary Diet (FOOD) trial and suggested delaying nasogastric feeding may decrease mortality in bulbar palsy patients (Dennis MS et al., 2005).
Although this is the common practice to get the nutritional needs, there is evidence that early enteral feeding is not nutritionally superior to early TPN administration. Moreover, there is more rapid recovery of both albumin and protein in patients started TPN rather than those of enteral feeding at least for the first 2 weeks of stroke which is the time of maximum risk of malnutrition (Yamada SM, 2015).
Bulbar palsy non ventilated cerebrovascular patients who are scheduled for nasogastric tube feeding are at a high risk of aspiration pneumonia, with incidence from 33% to 70% (Langdon PC et al., 2009). Dysfunction of Lower oesophageal sphincter is exaggerated by nasogastric tube, that means increase of incidence of gastroesophageal reflux and micro aspiration (Gomes GF., 2003). Also, nasogastric tube can be colonized by gram negative bacteria as nasogastric tube change gastric acidity and promote bacterial colonization and increasing risk of micro aspiration and sequent aspiration pneumonia (Spilker CA et al., 1996). So non ventilated cerebrovascular stroke patients suffering from bulbar palsy and scheduled for nasogastric tube enteral feeding are at risk of aspiration pneumonia (Warusevitane A et al., 2014).
Even though parenteral feeding has the advantage of protection from aspiration pneumonia, it has risk of complications like hyperglycaemia, refeeding-syndrome, bone demineralisation, catheter infections), fortunately these complications can be minimised by carefully monitoring patients and the use of teams for nutrition support especially during long-term PN.( Hartl WH et al., 2009)
Our goal in this study is to compare the incidence of aspiration pneumonia when keeping patients on total parenteral feeding regimen in comparison with early start of enteral feeding with nasogastric tube during early stage of stroke in stroke patients suffering from bulbar palsy.
- Conditions
- Aspiration Pneumonia
- Being tested
- Enteral nutrtion, TPN
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutrtionOther
enteral nutrition via nasogastric tube.
TPNOther
of NPO strategy except for medications to be given via nasogastric tube till 14 days from day of stroke with fulfilment of nutrition requirement by parenteral route
| Study group | Role | What they receive |
|---|---|---|
| enteral nutrition group | Experimental | patients will be scheduled for enteral nutrition via nasogastric tube.The amount of nasogastric feed given each day will be calculated according to the patient's calorie requirement and administered as 100 ml nasogastric tube feeding every four hours escalating to 200 ml every four hours according to patients' toleration and caloric needs. Patients will be positioned at ≥ 45° head-end elevation during feeds. They will be observed regularly during feeds, and the position of the nasogastric tube will be confirmed before each feed by auscultation by stethoscope. Receives: Other: Enteral nutrtion |
| total parentral nutrition group | Experimental | patients will be scheduled for continuation of NPO strategy except for medications to be given via nasogastric tube till 14 days from day of stroke with fulfilment of nutrition requirement by parenteral route Receives: Other: TPN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pneumonia
guided by The British Thoracic Society recommendations for definition pneumonia
Measured: within 14 days from inclusion in study
Secondary outcomes (3)
mechanical ventilation
Incidence of mechanical ventilation in both groups
Measured: 30 days from inclusion in the study,
mortality rate
incidence of mortality in both groups
Measured: 30 days from inclusion in the study,
catheter related infection
incidence of catheter related infection
Measured: 14 days from inclusion in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start5 May 2024
- Primary completion30 Nov 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration PneumoniaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants are to be resuscitated at first and second days of admission keeping all of them NPO then to be randomly divided according to the method of obtaining their nutritional needs into two groups. Energy target will be set at 30 kcal/ kg IBW in males and 25 Kcal/kg IBW in females, while protein requirements will be set at 1.2 g/kg IBW First group (group A): Group A patients will be scheduled for continuation of NPO strategy except for medications to be given via nasogastric tube till 14 days from day of stroke with fulfilment of nutrition requirement by parenteral route guided by Aspen2020 guidelines. Second group (group B): Group B patients will be scheduled for enteral nutrition via nasogastric tube.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adel ELansary, Principal investigator, Faculty of medicine, Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395740
- Sponsor's protocol ID
- FMASU R65/2024
- Acronym
- TPN
- Status last verified
- Mar 2024
- First submitted
- 29 Apr 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Incidence of Pneumonia in Non-ventilated Cerebrovascular Stroke Patients Suffering From Bulbar Palsy Depending on Nasogastric Tube Feeding and Those Who Are Totally Parenterally Fed.
- ClinicalTrials.gov ID
- NCT06395740
- Acronym / sponsor ID
- TPN / FMASU R65/2024
- Conditions
- Aspiration Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 2 May 2024 (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.
One of the most serious complications in the critically ill patient complaining of bulbar palsy is aspiration pneumonia. These patients are scheduled for nasogastric tube feeding trying to avoid recurrent aspiration and subsequent aspiration pneumonia. Even though, the risk of aspiration is still present. Putting a total parenteral nutrition regimen for these patients is a supposed strategy to avoid aspiration pneumonia till recovery from bulbar palsy or planning for tracheostomy and or feeding gastrostomy.
Detailed description
Aspiration pneumonia in cerebrovascular patients suffering from bulbar palsy can reach up to 60 %. (Martino R et al., 2012). All swallowing stages can be affected in cerebrovascular stroke patients. Difficulty in deglutition lower oesophageal sphincter dysfunction, delayed gastric empty and subsequent increase in gastric residual volume and decreased lower oesophageal sphincter tone and subsequent increase in gastroesophageal reflux all can be found in patients suffering from cerebrovascular stroke. (Schaller BJ et al., 2006).
As enteral feeding via oral route is risky in patients suffering from bulbar palsy, nasogastric tube is being used as a mode of enteral feeding till recovery from bulbar palsy or doing a gastrostomy tube as an alternative mode for enteral feeding. There is no survival benefit for early enteral feeding via nasogastric tube when compared with delayed tube feeding as formulated by the Feed or Ordinary Diet (FOOD) trial and suggested delaying nasogastric feeding may decrease mortality in bulbar palsy patients (Dennis MS et al., 2005).
Although this is the common practice to get the nutritional needs, there is evidence that early enteral feeding is not nutritionally superior to early TPN administration. Moreover, there is more rapid recovery of both albumin and protein in patients started TPN rather than those of enteral feeding at least for the first 2 weeks of stroke which is the time of maximum risk of malnutrition (Yamada SM, 2015).
Bulbar palsy non ventilated cerebrovascular patients who are scheduled for nasogastric tube feeding are at a high risk of aspiration pneumonia, with incidence from 33% to 70% (Langdon PC et al., 2009). Dysfunction of Lower oesophageal sphincter is exaggerated by nasogastric tube, that means increase of incidence of gastroesophageal reflux and micro aspiration (Gomes GF., 2003). Also, nasogastric tube can be colonized by gram negative bacteria as nasogastric tube change gastric acidity and promote bacterial colonization and increasing risk of micro aspiration and sequent aspiration pneumonia (Spilker CA et al., 1996). So non ventilated cerebrovascular stroke patients suffering from bulbar palsy and scheduled for nasogastric tube enteral feeding are at risk of aspiration pneumonia (Warusevitane A et al., 2014).
Even though parenteral feeding has the advantage of protection from aspiration pneumonia, it has risk of complications like hyperglycaemia, refeeding-syndrome, bone demineralisation, catheter infections), fortunately these complications can be minimised by carefully monitoring patients and the use of teams for nutrition support especially during long-term PN.( Hartl WH et al., 2009)
Our goal in this study is to compare the incidence of aspiration pneumonia when keeping patients on total parenteral feeding regimen in comparison with early start of enteral feeding with nasogastric tube during early stage of stroke in stroke patients suffering from bulbar palsy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All participants are to be resuscitated at first and second days of admission keeping all of them NPO then to be randomly divided according to the method of obtaining their nutritional needs into two groups. Energy target will be set at 30 kcal/ kg IBW in males and 25 Kcal/kg IBW in females, while protein requirements will be set at 1.2 g/kg IBW First group (group A): Group A patients will be scheduled for continuation of NPO strategy except for medications to be given via nasogastric tube till 14 days from day of stroke with fulfilment of nutrition requirement by parenteral route guided by Aspen2020 guidelines. Second group (group B): Group B patients will be scheduled for enteral nutrition via nasogastric tube.
| Arm | Type | Receives |
|---|---|---|
| enteral nutrition group | Experimental | Other: Enteral nutrtionpatients will be scheduled for enteral nutrition via nasogastric tube.The amount of nasogastric feed given each day will be calculated according to the patient's calorie requirement and administered as 100 ml nasogastric tube feeding every four hours escalating to 200 ml every four hours according to patients' toleration and caloric needs. Patients will be positioned at ≥ 45° head-end elevation during feeds. They will be observed regularly during feeds, and the position of the nasogastric tube will be confirmed before each feed by auscultation by stethoscope. |
| total parentral nutrition group | Experimental | Other: TPNpatients will be scheduled for continuation of NPO strategy except for medications to be given via nasogastric tube till 14 days from day of stroke with fulfilment of nutrition requirement by parenteral route |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. cerebrovascular stroke patients either ischemic or haemorrhagic within first 7 days 2. Age above 18 years 3. patients suffering from bulbar palsy.
Key exclusion criteria (2 listed)
- Mechanically ventilated patients at first presentation. 2. Patients suffering from attacks of fits. 3. Patients suffering from signs and symptoms of pneumonia before attack of cerebrovascular stroke.
- 4. Patients suffering from degenerative neurological diseases. 5. Patients with developmental delay or neurological disease. 6. Patients with hepatic or renal coma. 7. Patients with hemodynamic instability.
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 |
|---|---|---|
| Enteral nutrtionenteral nutrition via nasogastric tube. | Other | enteral nutrition group |
| TPNof NPO strategy except for medications to be given via nasogastric tube till 14 days from day of stroke with fulfilment of nutrition requirement by parenteral route | Other | total parentral nutrition group |
Primary outcome
Incidence of pneumonia
Time frame: within 14 days from inclusion in study
guided by The British Thoracic Society recommendations for definition pneumonia
3 secondary outcomes
mechanical ventilation
Time frame: 30 days from inclusion in the study,
mortality rate
Time frame: 30 days from inclusion in the study,
catheter related infection
Time frame: 14 days from inclusion in study
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 4 Aug 2026.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
Related trials for Aspiration Pneumonia
Recruiting
The Effects of Wintergreen Essential Oil Inhalation on Alleviating Dyspnea Among Patients With Pneumonia
Pneumonia, Dyspnea
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
RecruitingPhase 4
Gastrointestinal Dysmotility on Aspiration Risk
Esophageal Motility Disorders, Gastric Motor Dysfunction
Not yet recruitingObservational study
Surveillance of Neonatal Endotracheal Tube Colonisation
Ventilation, Mechanical, Ventilation-Associated Pneumonia
Not yet recruiting
Oropharyngeal Flushing Suction Tube With Laryngoscope for Stroke-Associated Pneumonia
Acute Ischemic Stroke, Stroke-Associated Pneumonia (SAP)
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.
Adel ELansary principal investigator
Faculty of medicine, Ain Shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enteral nutrtion and TPN in people with Aspiration Pneumonia, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 2 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 4 Aug 2026. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of pneumonia (time frame: within 14 days from inclusion in study). 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 4 Aug 2026.