Ventilator Acquired PneumoniaNCT07001163
Assessment of the Role of Probiotics in Prevention of Ventilator-Associated Pneumonia in Neonates
A study testing Probiotic in people with Ventilator Acquired Pneumonia, run by Lamiaa Khaled Zidan at 1 site in Egypt.
Trial summary
Evaluate the preventive value of probiotics on VAP among ventilated neonates. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Ventilator Acquired Pneumonia
- What is being tested?
- Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Jun 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All term neonates who required mechanical ventilation with ETT for more than 48 hours.
Who cannot join
- Early-onset neonatal sepsis
- Pre-existing pneumonia
- A patient who was unfit for enteral intake.
- Prematurity <37 gestational weeks.
- Surgical causes of mechanical ventilation
- Multiple congenital anomalies and suspected chromosomal anomalies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Tanta University
Tanta, Q2x2+cp Tanta 2, Egypt,, 31527
About this study
Evaluate the preventive value of probiotics on VAP among ventilated neonates.
Read the detailed description
MV is a critical component of neonatal intensive care, providing essential respiratory support for neonates with severe respiratory distress. However, its use is associated with an increased risk of VAP, a serious nosocomial lung infection. VAP is defined as a pneumonia diagnosed in patients undergoing MV for at least 48 hours and is recognized as the second most common nosocomial infection in neonatal and pediatric intensive care units. Its incidence ranges from 1 to 63 episodes per 1,000 ventilation days, with variability influenced by the socioeconomic and healthcare development of different regions.Given the complex pathophysiology of VAP, numerous prevention strategies have been proposed for NICUs.Among these strategies, probiotics have emerged.
- Conditions
- Ventilator Acquired Pneumonia
- Being tested
- Probiotic
- Keywords
- VAP, NICU
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic sachets contained 1× 109 colony-forming unit of Bifidobacterium Animalis subsp.lactis BB-12), were given via orogastric tube twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | 40 ventilated neonates who received commercially available probiotics Receives: Dietary Supplement: Probiotic |
| Non-probiotic group | No intervention | 40 ventilated neonates who only received the standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP incidence rate
Evaluation of the role of probiotics in the Prevention of neonatal VAP and examining their impact on the incidence of VAP at those neonates.
Measured: one year
Secondary outcomes (2)
GIT manifestations
Evaluation of the effect of probiotics in critically ventilated neonates on the incidence of GIT manifestations as Feeding intolerance, Vomiting, Constipation, or diarrhea.
Measured: one year
Duration of MV and NICU stay
Assessment of the impact of probiotic supplementation on critically ventilated neonates in terms of mechanical ventilation duration and NICU length of stay.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventilator Acquired PneumoniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lamiaa Khaled Zidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lamiaa Khaled Zidan, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001163
- Sponsor's protocol ID
- Probiotics in neonatal VAP
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bondarev DJ, Ryan RM, Mukherjee D. The spectrum of pneumonia among intubated neonates in the neonatal intensive care unit. J Perinatol. 2024 Sep;44(9):1235-1243. doi: 10.1038/s41372-024-01973-9. Epub 2024 May 2.
PubMed 38698211Iqbal F, Siva N, Kolibylu Raghupathy M, Edward S Lewis L, Barche A, Purkayastha J, S Nayak B. Probiotic effect in preterm neonates with sepsis - A systematic review protocol. F1000Res. 2024 Jul 5;11:913. doi: 10.12688/f1000research.122226.3. eCollection 2022.
PubMed 39114384Rangelova V, Kevorkyan A, Raycheva R, Krasteva M. Ventilator-Associated Pneumonia in the Neonatal Intensive Care Unit-Incidence and Strategies for Prevention. Diagnostics (Basel). 2024 Jan 23;14(3):240. doi: 10.3390/diagnostics14030240.
PubMed 38337756Khodair HA, Elmahdy HS, Zidan LK, Elashry SM, Elmashad AEM. Assessment of the role of probiotics in prevention of ventilator-associated pneumonia in neonates. Eur J Pediatr. 2025 Sep 4;184(9):597. doi: 10.1007/s00431-025-06380-6.
PubMed 40906025
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Role of Probiotics in Prevention of Ventilator-Associated Pneumonia in Neonates
- ClinicalTrials.gov ID
- NCT07001163
- Acronym / sponsor ID
- Probiotics in neonatal VAP
- Conditions
- Ventilator Acquired Pneumonia
- Keywords
- VAP, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lamiaa Khaled ZidanUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Jun 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.
Evaluate the preventive value of probiotics on VAP among ventilated neonates.
Detailed description
MV is a critical component of neonatal intensive care, providing essential respiratory support for neonates with severe respiratory distress. However, its use is associated with an increased risk of VAP, a serious nosocomial lung infection. VAP is defined as a pneumonia diagnosed in patients undergoing MV for at least 48 hours and is recognized as the second most common nosocomial infection in neonatal and pediatric intensive care units. Its incidence ranges from 1 to 63 episodes per 1,000 ventilation days, with variability influenced by the socioeconomic and healthcare development of different regions.Given the complex pathophysiology of VAP, numerous prevention strategies have been proposed for NICUs.Among these strategies, probiotics have emerged.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Dietary Supplement: Probiotic40 ventilated neonates who received commercially available probiotics |
| Non-probiotic group | No intervention | –40 ventilated neonates who only received the standard of care treatment |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All term neonates who required mechanical ventilation with ETT for more than 48 hours.
Key exclusion criteria (6 listed)
- Early-onset neonatal sepsis
- Pre-existing pneumonia
- A patient who was unfit for enteral intake.
- Prematurity <37 gestational weeks.
- Surgical causes of mechanical ventilation
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 |
|---|---|---|
| ProbioticProbiotic sachets contained 1× 109 colony-forming unit of Bifidobacterium Animalis subsp.lactis BB-12), were given via orogastric tube twice daily. | Dietary supplement | Probiotic group |
Primary outcome
VAP incidence rate
Time frame: one year
Evaluation of the role of probiotics in the Prevention of neonatal VAP and examining their impact on the incidence of VAP at those neonates.
2 secondary outcomes
GIT manifestations
Time frame: one year
Duration of MV and NICU stay
Time frame: one year
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 3 Jun 2025.
- Results publication: PubMed 38698211Bondarev DJ, Ryan RM, Mukherjee D. The spectrum of pneumonia among intubated neonates in the neonatal intensive care unit. J Perinatol. 2024 Sep;44(9):1235-1243. doi: 10.1038/s41372-024-01973-9. Epub 2024 May 2.
- Results publication: PubMed 39114384Iqbal F, Siva N, Kolibylu Raghupathy M, Edward S Lewis L, Barche A, Purkayastha J, S Nayak B. Probiotic effect in preterm neonates with sepsis - A systematic review protocol. F1000Res. 2024 Jul 5;11:913. doi: 10.12688/f1000research.122226.3. eCollection 2022.
- Results publication: PubMed 38337756Rangelova V, Kevorkyan A, Raycheva R, Krasteva M. Ventilator-Associated Pneumonia in the Neonatal Intensive Care Unit-Incidence and Strategies for Prevention. Diagnostics (Basel). 2024 Jan 23;14(3):240. doi: 10.3390/diagnostics14030240.
- Derived from this study: PubMed 40906025Khodair HA, Elmahdy HS, Zidan LK, Elashry SM, Elmashad AEM. Assessment of the role of probiotics in prevention of ventilator-associated pneumonia in neonates. Eur J Pediatr. 2025 Sep 4;184(9):597. doi: 10.1007/s00431-025-06380-6.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Ventilator Acquired Pneumonia, run by Lamiaa Khaled Zidan 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 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 3 Jun 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 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.
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?
VAP incidence rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001163, which also lists 4 linked publications.
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 3 Jun 2025.