Role of Oral Care in Mechanically Ventilated Preterm InfantsNCT07451964
Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants
A study testing oral care with maternal milk and oral care with sodium bicarbonate in people with Role of Oral Care in Mechanically Ventilated Preterm Infants, run by Ain Shams University at 1 site in Egypt.
Trial summary
70 Neonates in neonatal intensive care unit , ain shams university , children hospital Read more about this study
- Who is it for?
- Ages 0 hours to 3 days
- Conditions the study is for
- Role of Oral Care in Mechanically Ventilated Preterm Infants
- What is being tested?
- oral care with maternal milk and oral care with sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 30 Nov 2025
- 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 0 hours to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age less than 34 weeks
- Patients with moderate to severe respiratory distress syndrome on invasive mechanical ventilation in the 1st 3 days of life
- Available maternal breast milk
- Patients delivered by caesarean section
Who cannot join
- Patients with no available maternal breast milk
- Preterms who had a surgical procedure
- Patients with inborn error of metabolism
- Patients with major congenital anomalies
- Patients with hypoxic ischemic enceohalopathy
- Patients delivered by vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants
70 Neonates in neonatal intensive care unit , ain shams university , children hospital
Read the detailed description
preterms less than 34 weeks gestational age , with moderate to severe respiratory distress syndrome , available maternal milk and delivered by cesarean section
- Being tested
- oral care with maternal milk, oral care with sodium bicarbonate
- Keywords
- Oral care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral care with maternal milkOther
oral care with maternal milk every 3 hours
oral care with sodium bicarbonateOther
oral care with sodium bicarbonate every 3 hours
| Study group | Role | What they receive |
|---|---|---|
| maternal milk oral care group | Active comparator | Not described Receives: Other: oral care with maternal milk |
| sodium bicarbonate oral care group | Placebo comparator | Not described Receives: Other: oral care with sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of mechanical ventilation , length of hospital stay and mortality
Measured: 6 months
Secondary outcomes (1)
incidence of ventilator associated pneumonia , late onset sepsis and necrotizing enterocolitis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Jun 2025
- Primary completion1 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Role of Oral Care in Mechanically Ventilated Preterm InfantsStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Youssef, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451964
- Sponsor's protocol ID
- Oral care with maternal milk
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Oral Care With Maternal Milk in Mechanically Ventilated Preterm Infants
- ClinicalTrials.gov ID
- NCT07451964
- Acronym / sponsor ID
- Oral care with maternal milk
- Keywords
- Oral care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 5 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.
70 Neonates in neonatal intensive care unit , ain shams university , children hospital
Detailed description
preterms less than 34 weeks gestational age , with moderate to severe respiratory distress syndrome , available maternal milk and delivered by cesarean section
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maternal milk oral care group | Active comparator | Other: oral care with maternal milk |
| sodium bicarbonate oral care group | Placebo comparator | Other: oral care with sodium bicarbonate |
Who may qualify
- Ages
- 0 hours to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age less than 34 weeks
- Patients with moderate to severe respiratory distress syndrome on invasive mechanical ventilation in the 1st 3 days of life
- Available maternal breast milk
- Patients delivered by caesarean section
Key exclusion criteria (6 listed)
- Patients with no available maternal breast milk
- Preterms who had a surgical procedure
- Patients with inborn error of metabolism
- Patients with major congenital anomalies
- Patients with hypoxic ischemic enceohalopathy
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 |
|---|---|---|
| oral care with maternal milkoral care with maternal milk every 3 hours | Other | maternal milk oral care group |
| oral care with sodium bicarbonateoral care with sodium bicarbonate every 3 hours | Other | sodium bicarbonate oral care group |
Primary outcome
duration of mechanical ventilation , length of hospital stay and mortality
Time frame: 6 months
1 secondary outcome
incidence of ventilator associated pneumonia , late onset sepsis and necrotizing enterocolitis
Time frame: 6 months
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 6 Mar 2026.
- Individual participant dataSharing planned: No
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 oral care with maternal milk and oral care with sodium bicarbonate in people with Role of Oral Care in Mechanically Ventilated Preterm Infants, 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 4 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 6 Mar 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. Some participants in this study may receive a placebo. 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?
duration of mechanical ventilation , length of hospital stay and mortality (time frame: 6 months). 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 6 Mar 2026.