Preterm BabiesPIOMINCT06046157
Oral Motor Intervention for Preterm Babies
A study testing Breast milk-scented PIOMI and Breast milk-tasting PIOMI in people with Preterm Babies, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effect of oral motor intervention (PIOMI) applied to preterm babies along with the smell and taste of breast milk on feeding parameters and the transition time to oral feeding. Read more about this study
- Who is it for?
- Ages 28 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Babies
- What is being tested?
- Breast milk-scented PIOMI and Breast milk-tasting PIOMI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 31 May 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 28 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Breastfed,
- Preterm babies with a gestational age of 28-32 weeks,
- No facial deformity,
- No respiratory, cardiovascular, gastrointestinal or neurological disorders or syndromes that would prevent or complicate oral feeding,
- It will produce preterm babies who are not fed orally but are fed via tube (orogastric).
Who cannot join
- Having respiratory distress,
- Babies who do not receive informed consent form from the parents will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Motor Intervention on Feeding Parameters in Preterm Babies
The goal of this clinical trial is to evaluate the effect of oral motor intervention (PIOMI) applied to preterm babies along with the smell and taste of breast milk on feeding parameters and the transition time to oral feeding. The main questions it aims to answer are:
- Does affect nutritional parameters PIOMI with the smell of breast milk?
- Does affect nutritional parameters PIOMI with breast milk taste? Participants will consist of breast milk-scented PIOMI, breast milk-tasting PIOMI and control groups.
Researchers will compare breast milk-scented PIOMI, breast milk-tasting PIOMI and control groups to see if early feeding skills.
Read the detailed description
The preterm newborn population is potentially unable to be fed orally for a long time during the postnatal period. Since the physiological functions of preterm babies have not yet matured, their adaptation to the external uterine environment is more complicated. This also means long hospital stays for premature babies. One of the main criteria for a preterm baby to be discharged from the hospital is to be able to feed orally.
Premature oral motor intervention (PIOMI) is included in the literature as one of the treatment programs to improve the oral motor control and neurobehavioral status of preterm babies. No study design has been found regarding PIOMI, which is applied to preterm babies with the smell and taste of breast milk. This research was planned to evaluate the effect of oral motor intervention (PIOMI) applied to preterm babies along with the smell and taste of breast milk on feeding parameters.
- Conditions
- Preterm Babies
- Being tested
- Breast milk-scented PIOMI, Breast milk-tasting PIOMI
- Keywords
- Premature infant oral motor intervention (PIOMI), Premature, Nutrition
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast milk-scented PIOMIOther
During PIOMI, the scent of breast milk will be provided through cotton soaked in breast milk placed 1.5 cm away from the babies.
PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally.
It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers.
Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength.
Breast milk-tasting PIOMIOther
The finger used during PIOMI application will be performed by dipping it into breast milk. This will ensure that babies taste breast milk.
PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally.
It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers.
Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength.
| Study group | Role | What they receive |
|---|---|---|
| Breast milk-scented PIOMI | Experimental | During PIOMI application, the baby will be smelled his/her own breast milk. Receives: Other: Breast milk-scented PIOMI |
| Breast milk-tasting PIOMI | Experimental | During PIOMI application, the baby will be able to taste his own breast milk. The finger on which PIOMI was applied will be immersed in breast milk. Receives: Other: Breast milk-tasting PIOMI |
| Control | No intervention | Only PIOMI application will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early feeding skills
EFS was revised to evaluate the feeding skills of preterm infants. The EFS 19 items in 5 subscales: respiratory regulation, oral-motor function, swallowing coordination, engagement, and physiologic stability.
The tool includes items that evaluate the development of oral feeding skills and items that describe observable indicators of a problem during feeding. Items related to feeding skills are evaluated using the following 3-option structure: skill not yet observed 1, skill emerging 2 and skill consistently observed 3 with minor variations in wording depending on the item. Indicators of problems within a skill are scored using a frequency-based 3-option structure: frequent indication of problem 1, occasional indication of problem 2, and never or rare indication of a problem 3 and again, the specific wording varies by item. The overall EFS score is the sum of the 5 subscale scores and ranges from 19 to 57. Higher scores indicate more mature feeding skills.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2023
- Primary completion31 Jan 2025
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BabiesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- MSc İlknur Budancamanak, Professor Kadir Şerafettin Tekgündüz, Associate Professor Mustafa Kara, MSc Ebru Betül Albayrak
- Responsible party
- Principal investigator, Türkan Kadiroğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046157
- Sponsor's protocol ID
- B. 30.2. ATA.0.01.00/702
- Acronym
- PIOMI
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Motor Intervention on Feeding Parameters in Preterm Babies
- ClinicalTrials.gov ID
- NCT06046157
- Acronym / sponsor ID
- PIOMI / B. 30.2. ATA.0.01.00/702
- Conditions
- Preterm Babies
- Keywords
- Premature infant oral motor intervention (PIOMI), Premature, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- MSc İlknur Budancamanak, Professor Kadir Şerafettin Tekgündüz, Associate Professor Mustafa Kara, MSc Ebru Betül Albayrak
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 21 Sep 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.
The goal of this clinical trial is to evaluate the effect of oral motor intervention (PIOMI) applied to preterm babies along with the smell and taste of breast milk on feeding parameters and the transition time to oral feeding. The main questions it aims to answer are:
- Does affect nutritional parameters PIOMI with the smell of breast milk?
- Does affect nutritional parameters PIOMI with breast milk taste? Participants will consist of breast milk-scented PIOMI, breast milk-tasting PIOMI and control groups.
Researchers will compare breast milk-scented PIOMI, breast milk-tasting PIOMI and control groups to see if early feeding skills.
Detailed description
The preterm newborn population is potentially unable to be fed orally for a long time during the postnatal period. Since the physiological functions of preterm babies have not yet matured, their adaptation to the external uterine environment is more complicated. This also means long hospital stays for premature babies. One of the main criteria for a preterm baby to be discharged from the hospital is to be able to feed orally.
Premature oral motor intervention (PIOMI) is included in the literature as one of the treatment programs to improve the oral motor control and neurobehavioral status of preterm babies. No study design has been found regarding PIOMI, which is applied to preterm babies with the smell and taste of breast milk. This research was planned to evaluate the effect of oral motor intervention (PIOMI) applied to preterm babies along with the smell and taste of breast milk on feeding parameters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast milk-scented PIOMI | Experimental | Other: Breast milk-scented PIOMIDuring PIOMI application, the baby will be smelled his/her own breast milk. |
| Breast milk-tasting PIOMI | Experimental | Other: Breast milk-tasting PIOMIDuring PIOMI application, the baby will be able to taste his own breast milk. The finger on which PIOMI was applied will be immersed in breast milk. |
| Control | No intervention | –Only PIOMI application will be made. |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Breastfed,
- Preterm babies with a gestational age of 28-32 weeks,
- No facial deformity,
- No respiratory, cardiovascular, gastrointestinal or neurological disorders or syndromes that would prevent or complicate oral feeding,
- It will produce preterm babies who are not fed orally but are fed via tube (orogastric).
Key exclusion criteria (2 listed)
- Having respiratory distress,
- Babies who do not receive informed consent form from the parents will not be included.
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 |
|---|---|---|
| Breast milk-scented PIOMIDuring PIOMI, the scent of breast milk will be provided through cotton soaked in breast milk placed 1.5 cm away from the babies. PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally. It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers. Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength. | Other | Breast milk-scented PIOMI |
| Breast milk-tasting PIOMIThe finger used during PIOMI application will be performed by dipping it into breast milk. This will ensure that babies taste breast milk. PIOMI: Oral motor intervention for premature infants is a standardized oral motor therapy for preterm infants that has been shown to have strong intervention fidelity and has been tested internationally. It is a 5-minute, 8-step focused therapy designed to help the premature baby respond functionally to lip, chin and lip movements and pressure, applied for 7 consecutive days using all aseptic precautions with gloved fingers. Intervention provides assisted movement to activate muscle contraction and movement against resistance to build strength. | Other | Breast milk-tasting PIOMI |
Primary outcome
Early feeding skills
Time frame: 12 week
EFS was revised to evaluate the feeding skills of preterm infants. The EFS 19 items in 5 subscales: respiratory regulation, oral-motor function, swallowing coordination, engagement, and physiologic stability. The tool includes items that evaluate the development of oral feeding skills and items that describe observable indicators of a problem during feeding. Items related to feeding skills are evaluated using the following 3-option structure: skill not yet observed 1, skill emerging 2 and skill consistently observed 3 with minor variations in wording depending on the item. Indicators of problems within a skill are scored using a frequency-based 3-option structure: frequent indication of problem 1, occasional indication of problem 2, and never or rare indication of a problem 3 and again, the specific wording varies by item. The overall EFS score is the sum of the 5 subscale scores and ranges from 19 to 57. Higher scores indicate more mature feeding skills.
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 28 Sep 2026.
- Individual participant dataSharing planned: No
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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 Breast milk-scented PIOMI and Breast milk-tasting PIOMI in people with Preterm Babies, run by Ataturk 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 5 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 28 Sep 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 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?
Early feeding skills (time frame: 12 week). 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 28 Sep 2026.