Ventilator-Associated PneumoniaNCT07482007
Oropharyngeal Care With Colostrum, Chlorohexidine and Sodium Bicarbonate in Preventing Ventilator-associated Pneumonia in Preterm Neonates
A study testing Oropharyngeal Care with Colostrum, Chlorhexidine Oral Care and Sodium Bicarbonate oral care in people with Ventilator-Associated Pneumonia, run by Tanta University at 1 site in Egypt.
Trial summary
comparing the effect of oral care with colostrum, chlorohexidine and sodium bicarbonate in prevention of ventilator-associated pneumonia in preterm neonates. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventilator-Associated Pneumonia
- What is being tested?
- Oropharyngeal Care with Colostrum, Chlorhexidine Oral Care and Sodium Bicarbonate oral care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Mar 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm neonates with gestational age less than 37 weeks. Neonates admitted to the Neonatal Intensive Care Unit (NICU). Neonates requiring invasive mechanical ventilation for more than 48 hours. Age ≤ 72 hours at time of enrollment. Written informed consent obtained from parents or legal guardians.
Who cannot join
- Neonates with major congenital anomalies. Neonates with congenital airway malformations. Presence of congenital pneumonia at birth. Neonates with severe gastrointestinal malformations preventing enteral feeding. Neonates who develop early-onset sepsis at admission. Neonates with contraindications to oral care procedures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Unit, Tanta University Children's Hospital
Tanta
About this study
Official title: Comparative Study of Oropharyngeal Care With Colostrum, Chlorohexidine and Sodium Bicarbonate in Preventing Ventilator-associated Pneumonia in Preterm Neonates
comparing the effect of oral care with colostrum, chlorohexidine and sodium bicarbonate in prevention of ventilator-associated pneumonia in preterm neonates.
Read the detailed description
Randomized controlled trial
- Conditions
- Ventilator-Associated Pneumonia
- Being tested
- Oropharyngeal Care with Colostrum, Chlorhexidine Oral Care, Sodium Bicarbonate oral care, Normal Saline Oral Care
- 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.
Oropharyngeal Care with ColostrumOther
Application of small amounts of expressed maternal colostrum to the oral mucosa of ventilated preterm neonates using sterile swabs every 3-4 hours according to NICU oral care protocol.
Chlorhexidine Oral CareDrug
Oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity of ventilated preterm neonates at scheduled intervals according to NICU protocol.
Sodium Bicarbonate oral careOther
Preterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs.
Normal Saline Oral CareOther
Routine oropharyngeal care using sterile normal saline applied with sterile swabs at regular intervals during mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Colostrum Group | Experimental | Preterm neonates receiving oropharyngeal care with expressed maternal colostrum applied to the oral mucosa using sterile swabs at regular intervals during mechanical ventilation. Receives: Other: Oropharyngeal Care with Colostrum |
| Chlorhexidine Group | Experimental | Preterm neonates receiving oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity using sterile swabs. Receives: Drug: Chlorhexidine Oral Care |
| Sodium Bicarbonate Group | Experimental | Preterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs. Receives: Other: Sodium Bicarbonate oral care |
| Control Group (Normal Saline) | Experimental | Preterm neonates receiving routine oral care using sterile normal saline. Receives: Other: Normal Saline Oral Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ventilator-Associated Pneumonia (VAP)
To compare the incidence of ventilator-associated pneumonia among preterm neonates receiving different types of oropharyngeal care (colostrum, chlorhexidine, sodium bicarbonate, or normal saline). Diagnosis of VAP will be based on clinical signs, radiological findings, and microbiological evidence according to NICU infection
Measured: Up to 28 days after initiation of mechanical ventilation.
Secondary outcomes (5)
1.Time to Development of Ventilator-Associated Pneumonia
Time interval between initiation of mechanical ventilation and the first diagnosis of ventilator-associated pneumonia.
Measured: From initiation of mechanical ventilation up to 28 days.
2.Duration of Mechanical Ventilation
Total duration of invasive mechanical ventilation required by preterm neonates in each study group.
Measured: From initiation of mechanical ventilation until successful extubation, up to 28 days.
3. Length of Neonatal Intensive Care Unit (NICU) Stay
Total number of days the neonate remains admitted in the NICU.
Measured: From NICU admission until discharge, up to 60 days.
4.Neonatal Mortality
All-cause mortality among ventilated preterm neonates during NICU hospitalization.
Measured: From NICU admission until discharge, up to 60 days
5. Oropharyngeal Bacterial Colonization
Presence and type of bacterial colonization detected in oropharyngeal swab cultures among ventilated preterm neonates.
Measured: Baseline and up to 28 days after initiation of mechanical ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Apr 2024
- Primary completion1 Jan 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Preterm neonates requiring mechanical ventilation will be randomly assigned into four parallel groups to receive different types of oropharyngeal care (colostrum, chlorhexidine, sodium bicarbonate or saline). Oral care will be performed according to a standardized NICU protocol at regular intervals during mechanical ventilation. The incidence of ventilator-associated pneumonia will be compared among the four groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mohamed Salah, Tanta University
- Investigators
- Dalia Ayoub, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482007
- Sponsor's protocol ID
- 36264MS499/2/24
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Oropharyngeal Care With Colostrum, Chlorohexidine and Sodium Bicarbonate in Preventing Ventilator-associated Pneumonia in Preterm Neonates
- ClinicalTrials.gov ID
- NCT07482007
- Acronym / sponsor ID
- 36264MS499/2/24
- Conditions
- Ventilator-Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 19 Mar 2026 (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.
comparing the effect of oral care with colostrum, chlorohexidine and sodium bicarbonate in prevention of ventilator-associated pneumonia in preterm neonates.
Detailed description
Randomized controlled trial
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Preterm neonates requiring mechanical ventilation will be randomly assigned into four parallel groups to receive different types of oropharyngeal care (colostrum, chlorhexidine, sodium bicarbonate or saline). Oral care will be performed according to a standardized NICU protocol at regular intervals during mechanical ventilation. The incidence of ventilator-associated pneumonia will be compared among the four groups.
| Arm | Type | Receives |
|---|---|---|
| Colostrum Group | Experimental | Other: Oropharyngeal Care with ColostrumPreterm neonates receiving oropharyngeal care with expressed maternal colostrum applied to the oral mucosa using sterile swabs at regular intervals during mechanical ventilation. |
| Chlorhexidine Group | Experimental | Drug: Chlorhexidine Oral CarePreterm neonates receiving oropharyngeal care using diluted chlorhexidine solution applied to the oral cavity using sterile swabs. |
| Sodium Bicarbonate Group | Experimental | Other: Sodium Bicarbonate oral carePreterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs. |
| Control Group (Normal Saline) | Experimental | Other: Normal Saline Oral CarePreterm neonates receiving routine oral care using sterile normal saline. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Preterm neonates with gestational age less than 37 weeks. Neonates admitted to the Neonatal Intensive Care Unit (NICU). Neonates requiring invasive mechanical ventilation for more than 48 hours. Age ≤ 72 hours at time of enrollment. Written informed consent obtained from parents or legal guardians.
Key exclusion criteria (1 listed)
- Neonates with major congenital anomalies. Neonates with congenital airway malformations. Presence of congenital pneumonia at birth. Neonates with severe gastrointestinal malformations preventing enteral feeding. Neonates who develop early-onset sepsis at admission. Neonates with contraindications to oral care procedures.
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 |
|---|---|---|
| Oropharyngeal Care with ColostrumApplication of small amounts of expressed maternal colostrum to the oral mucosa of ventilated preterm neonates using sterile swabs every 3-4 hours according to NICU oral care protocol. | Other | Colostrum Group |
| Chlorhexidine Oral CareOropharyngeal care using diluted chlorhexidine solution applied to the oral cavity of ventilated preterm neonates at scheduled intervals according to NICU protocol. | Drug | Chlorhexidine Group |
| Sodium Bicarbonate oral carePreterm neonates receiving oral care using sodium bicarbonate solution applied to the oral mucosa using sterile swabs. | Other | Sodium Bicarbonate Group |
| Normal Saline Oral CareRoutine oropharyngeal care using sterile normal saline applied with sterile swabs at regular intervals during mechanical ventilation. | Other | Control Group (Normal Saline) |
Primary outcome
Incidence of Ventilator-Associated Pneumonia (VAP)
Time frame: Up to 28 days after initiation of mechanical ventilation.
To compare the incidence of ventilator-associated pneumonia among preterm neonates receiving different types of oropharyngeal care (colostrum, chlorhexidine, sodium bicarbonate, or normal saline). Diagnosis of VAP will be based on clinical signs, radiological findings, and microbiological evidence according to NICU infection
5 secondary outcomes
1.Time to Development of Ventilator-Associated Pneumonia
Time frame: From initiation of mechanical ventilation up to 28 days.
2.Duration of Mechanical Ventilation
Time frame: From initiation of mechanical ventilation until successful extubation, up to 28 days.
3. Length of Neonatal Intensive Care Unit (NICU) Stay
Time frame: From NICU admission until discharge, up to 60 days.
4.Neonatal Mortality
Time frame: From NICU admission until discharge, up to 60 days
5. Oropharyngeal Bacterial Colonization
Time frame: Baseline and up to 28 days after initiation of mechanical ventilation.
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 Jun 2026.
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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.
Dalia Ayoub principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oropharyngeal Care with Colostrum, Chlorhexidine Oral Care and Sodium Bicarbonate oral care in people with Ventilator-Associated Pneumonia, run by Tanta 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 1 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 Jun 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.
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 Ventilator-Associated Pneumonia (VAP) (time frame: Up to 28 days after initiation of mechanical ventilation.). 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 Jun 2026.