BreastmilkNCT06129266
Oral Care With Breast Milk in Preterm Newborns Fed by Tube
A study testing oral care with breastmilk in people with Breastmilk and Oral Care, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
It was conducted to evaluate Oral Care with Breast Milk in Preterm Newborns Fed by Tube Read more about this study
- Who is it for?
- Ages 28 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Breastmilk, Oral Care
- What is being tested?
- oral care with breastmilk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 21 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 28 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -Staying in the neonatal intensive care unit
- Being fed by gavage
- Babies with no oral intake (nonperoral-NPO)
- Babies fed with breast milk and/or formula
Who cannot join
- Babies who are exclusively breastfed
- Cleft palate/lip
- Major congenital anomaly
- Intubated babies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Care With Breast Milk in Preterm Newborns Fed by Tube:A Randomized Controlled Study
It was conducted to evaluate Oral Care with Breast Milk in Preterm Newborns Fed by Tube
Read the detailed description
Newborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. Breast milk (BM) will be used for oral care. At each treatment, two ml BM should be dropped onto sterile gauze to clean the cheeks, tongue and palate. Process steps; After hand hygiene is achieved, it will be done using disposable gloves.
- Conditions
- Breastmilk, Oral Care
- Being tested
- oral care with breastmilk
- Keywords
- breastmilk, oral care, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral care with breastmilkOther
Also called routine maintenance
No intervention will be applied to the control group other than oral care with sterile distilled water, which is routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| İntervention (Oral care with breastmilk) group | Experimental | Newborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. Breast milk (BM) will be used for oral care. At each treatment, two ml BM should be dropped onto sterile gauze to clean the cheeks, tongue and palate. Process steps; After hand hygiene is achieved, it will be done using disposable gloves. Receives: Other: oral care with breastmilk |
| Routine maintenance group | No intervention | No intervention will be applied to the control group other than oral care with sterile distilled water, which is routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Care with Breast Milk in Tube-Fed Preterm Newborns: Randomized Controlled Study
Oral care
Measured: from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start15 Jan 2024
- Primary completion23 Apr 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastmilkStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Cuvadar, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129266
- Sponsor's protocol ID
- 13/38
- Status last verified
- Jun 2024
- First submitted
- 4 Nov 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cuvadar A, Camur Z, Zafer Dinckol R. Oral Care Performed with Breast Milk in Preterm Newborns Fed by Tube: A Randomized Controlled Study. Breastfeed Med. 2025 Jan;20(1):73-79. doi: 10.1089/bfm.2024.0214. Epub 2024 Oct 28.
PubMed 39466047
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care With Breast Milk in Preterm Newborns Fed by Tube:A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06129266
- Acronym / sponsor ID
- 13/38
- Conditions
- Breastmilk, Oral Care
- Keywords
- breastmilk, oral care, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 13 Nov 2023 (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.
It was conducted to evaluate Oral Care with Breast Milk in Preterm Newborns Fed by Tube
Detailed description
Newborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. Breast milk (BM) will be used for oral care. At each treatment, two ml BM should be dropped onto sterile gauze to clean the cheeks, tongue and palate. Process steps; After hand hygiene is achieved, it will be done using disposable gloves.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention (Oral care with breastmilk) group | Experimental | Other: oral care with breastmilkNewborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. Breast milk (BM) will be used for oral care. At each treatment, two ml BM should be dropped onto sterile gauze to clean the cheeks, tongue and palate. Process steps; After hand hygiene is achieved, it will be done using disposable gloves. |
| Routine maintenance group | No intervention | –No intervention will be applied to the control group other than oral care with sterile distilled water, which is routine clinical practice. |
Who may qualify
- Ages
- 28 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- -Staying in the neonatal intensive care unit
- Being fed by gavage
- Babies with no oral intake (nonperoral-NPO)
- Babies fed with breast milk and/or formula
Key exclusion criteria (4 listed)
- Babies who are exclusively breastfed
- Cleft palate/lip
- Major congenital anomaly
- Intubated babies
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 breastmilkAlso: routine maintenanceNo intervention will be applied to the control group other than oral care with sterile distilled water, which is routine clinical practice. | Other | İntervention (Oral care with breastmilk) group |
Primary outcome
Oral Care with Breast Milk in Tube-Fed Preterm Newborns: Randomized Controlled Study
Time frame: from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon.
Oral care
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 25 Jun 2024.
- Derived from this study: PubMed 39466047Cuvadar A, Camur Z, Zafer Dinckol R. Oral Care Performed with Breast Milk in Preterm Newborns Fed by Tube: A Randomized Controlled Study. Breastfeed Med. 2025 Jan;20(1):73-79. doi: 10.1089/bfm.2024.0214. Epub 2024 Oct 28.
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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 oral care with breastmilk in people with Breastmilk and Oral Care, run by Karabuk University at 1 site in Turkey (Türkiye).
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 4 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 25 Jun 2024. 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 Turkey (Türkiye). 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?
Oral Care with Breast Milk in Tube-Fed Preterm Newborns: Randomized Controlled Study (time frame: from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon.). 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 NCT06129266, which also lists 1 linked publication.
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 25 Jun 2024.