PretermPIOMINCT07894380
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
A study testing The PIOMI initiative in maternal interaction in people with Preterm and Preterm Infant Development, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Premature Infant Oral Motor Intervention (PIOMI) has been found to improve short-term clinical outcomes in preterm infants and contribute to their feeding skills. In preterm infants, PIOMI can improve weight and facilitate early 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, Preterm Infant Development
- What is being tested?
- The PIOMI initiative in maternal interaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- - Infants who are breastfed,
- have no congenital anomalies or neurological problems,
- have not undergone surgery,
- are in stable general condition and are fed enterally,
- have no respiratory, cardiovascular or gastrointestinal problems that would prevent or complicate oral feeding,
- and whose parents are willing to participate in the study.
Who cannot join
- Infants requiring resuscitation,
- with deteriorating general condition,
- with additional diagnoses such as sepsis, NEC, etc.,
- with excessive skin sensitivity, and
- whose parents wish to be separated from work.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University Faculty of Nursing
Erzurum, Aziziye
Türkan Kadiroğlu, PhD, +90 05309223025 ext. +9004422315736, turkankadiroglu@gmail.com
About this study
Official title: The Effect of Oral Motor Intervention (PIOMI) in Mother-Infant Interaction on Feeding Maturity in Preterm Newborns: A Non-Invasive Objective Assessment
Premature Infant Oral Motor Intervention (PIOMI) has been found to improve short-term clinical outcomes in preterm infants and contribute to their feeding skills. In preterm infants, PIOMI can improve weight and facilitate early oral feeding. Furthermore, PIOMI can shorten the length of hospital stay and the separation time between the infant and caregiver in preterm infants. The primary aim of this project is to evaluate the effect of PIOMI in mother-infant interaction (applied with the infant in the mother's arms and accompanied by the mother's voice) on feeding readiness, suckling success, mothers' breastfeeding attitudes and infants' feeding maturity in preterm newborns. The secondary objective is to investigate whether PIOMI applied in mother-infant interaction affects mothers' positive and negative emotional states.
- Conditions
- Preterm, Preterm Infant Development
- Being tested
- The PIOMI initiative in maternal interaction, Control
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The PIOMI initiative in maternal interactionOther
PIOMI will be administered to preterm infants at YYBÜ alongside feeding procedures. This therapy will be administered once daily for seven consecutive days by the same practitioner, with maternal interaction.
ControlOther
PIOMI application
| Study group | Role | What they receive |
|---|---|---|
| PIOMI Group | Active comparator | The PIOMI application will be administered to the control group. Receives: Other: Control |
| PIOMI initiative focuses on mother-infant interaction | Experimental | The PIOMI intervention will be administered to the experimental group during maternal interaction. Receives: Other: The PIOMI initiative in maternal interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Swallow Count
The Neonatal Oral Feeding Monitor is a non-invasive medical device designed to assess feeding maturity. NeoSAFE takes measurements using two sensors. These sensors are placed under the infant's chin in the hyoid region and on the right abdominal area below the diaphragm to monitor the infant's respiration and swallowing movements during oral feeding. To ensure adequate monitoring, the procedure is carried out for at least two minutes while the data stream from the monitor is observed. Data collected via the sensors are categorized to evaluate the infant's feeding maturity.
Description: Total number of detected swallows during feeding.
Measured: 1-7 day
Respiration Rate (bpm)
Description: The amount of infant breath moments recorded per minute during the feeding session. It is expressed in breaths per minute (bpm) and reflects the respiratory function and oxygenation of the infant.
Measured: 1-7 day
Inspirium After Swallow Count
Description: Number of detected inspirium after swallowing events in a feeding session. This parameter is analyzed in two groups: inspiriums that overlap with swallow events and inspiriums that do not overlap with swallows but the interval in between is too short which may lead to aspiration. The total number of Inspirium After Swallow 's is obtained by summing these two groups.
Measured: 1-7 day
Overlapped Inspirium After Swallow Events: Overlapped Inspirium After Swallow Percentage & Average Overlapped Inspirium After Swallow Duration
Description: Overlapped Inspirium After Swallow events represent the number of inspirium states that overlap with swallows. The overlapped Inspirium After Swallow percentage expresses the average percentage of the ratio of the overlap time to total swallow time, whereas the average overlapped Inspirium After Swallow duration represents the average duration of the overlapping inspirium with swallows. These parameters can be better understood with numerical examples, as in the following sections.
Measured: 1-7 day
Maximum Rhythmic Swallow
Description: The maximum number of swallows that the infant can perform in a rhythmic cycle without a resting interval. This parameter represents the number of swallows in the longest rhythmic cycle that the infant demonstrates. It indicates how well the infant can swallow without requiring rest intervals. A higher number suggests that the infant can swallow more smoothly and effectively, while a lower number indicates the need for more rest intervals between swallows.
Measured: 1-7 day
Minimum Rhythmic Swallow
Description: The minimum number of swallows that the infant can perform in a rhythmic cycle without any rest interval. This parameter reflects the infant's swallowing consistency and stability. A higher value indicates the infant can maintain a regular swallowing pattern, while a lower value implies more variability in their swallowing rhythm.
Measured: 1-7 day
Average Time Between Rhythmic Swallows
Description: The average time of the intervals between consecutive rhythmic swallow groups. This parameter shows the infant's resting behavior. A longer interval indicates that the infant takes more extended breaks between the rhythmic swallow events, while a shorter interval suggests the infant swallows more rapidly and smoothly.
Measured: 1-7 day
Resting Interval Count
Description: Total number of rest intervals when rhythmic swallowing is not observed.
Measured: 1-7 day
Secondary outcomes (1)
Preterm Infant Oral Feeding Readiness
Preterm Infant Oral Feeding Readiness Assessment Scale (T-POFRAS): T-POFRAS is an observational scale developed by Fujinaga et al. It consists of 18 items across five categories (corrected gestational age, behavioral organization, oral posture, oral reflexes, and non-nutritive sucking) and assesses oral feeding readiness in preterm infants. The scale is scored from 0 to 2 per item, with a maximum total score of 36. The cutoff score for transitioning a preterm infant to oral feeding was established as 30 (Fujinaga et al., 2013). In the Turkish adaptation of the scale-validated for reliability and validity by Çamur and Çetinkaya-the cutoff score was determined to be 29 (Çamur \& Çetinkaya, 2021). The assessment of the preterm infant using T-POFRAS is conducted as follows: prior to the scheduled feeding time, the researcher first places the infant-who is inside the incubator-in a lateral decubitus position. The infant is awakened through gentle tactile stimulation or by being called by na
Measured: 1-7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Feb 2026
- Primary completion1 Sep 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Türkan Kadiroğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894380
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/608
- Acronym
- PIOMI
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Motor Intervention (PIOMI) in Mother-Infant Interaction on Feeding Maturity in Preterm Newborns: A Non-Invasive Objective Assessment
- ClinicalTrials.gov ID
- NCT07894380
- Acronym / sponsor ID
- PIOMI / B.30.2.ATA.0.01.00/608
- Conditions
- Preterm, Preterm Infant Development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 26 Oct 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.
Premature Infant Oral Motor Intervention (PIOMI) has been found to improve short-term clinical outcomes in preterm infants and contribute to their feeding skills. In preterm infants, PIOMI can improve weight and facilitate early oral feeding. Furthermore, PIOMI can shorten the length of hospital stay and the separation time between the infant and caregiver in preterm infants. The primary aim of this project is to evaluate the effect of PIOMI in mother-infant interaction (applied with the infant in the mother's arms and accompanied by the mother's voice) on feeding readiness, suckling success, mothers' breastfeeding attitudes and infants' feeding maturity in preterm newborns. The secondary objective is to investigate whether PIOMI applied in mother-infant interaction affects mothers' positive and negative emotional states.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIOMI Group | Active comparator | Other: ControlThe PIOMI application will be administered to the control group. |
| PIOMI initiative focuses on mother-infant interaction | Experimental | Other: The PIOMI initiative in maternal interactionThe PIOMI intervention will be administered to the experimental group during maternal interaction. |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- - Infants who are breastfed,
- have no congenital anomalies or neurological problems,
- have not undergone surgery,
- are in stable general condition and are fed enterally,
- have no respiratory, cardiovascular or gastrointestinal problems that would prevent or complicate oral feeding,
Key exclusion criteria (5 listed)
- Infants requiring resuscitation,
- with deteriorating general condition,
- with additional diagnoses such as sepsis, NEC, etc.,
- with excessive skin sensitivity, and
- whose parents wish to be separated from work.
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 |
|---|---|---|
| The PIOMI initiative in maternal interactionPIOMI will be administered to preterm infants at YYBÜ alongside feeding procedures. This therapy will be administered once daily for seven consecutive days by the same practitioner, with maternal interaction. | Other | PIOMI initiative focuses on mother-infant interaction |
| ControlPIOMI application | Other | PIOMI Group |
Primary outcome
Total Swallow Count
Time frame: 1-7 day
The Neonatal Oral Feeding Monitor is a non-invasive medical device designed to assess feeding maturity. NeoSAFE takes measurements using two sensors. These sensors are placed under the infant's chin in the hyoid region and on the right abdominal area below the diaphragm to monitor the infant's respiration and swallowing movements during oral feeding. To ensure adequate monitoring, the procedure is carried out for at least two minutes while the data stream from the monitor is observed. Data collected via the sensors are categorized to evaluate the infant's feeding maturity. Description: Total number of detected swallows during feeding.
Respiration Rate (bpm)
Time frame: 1-7 day
Description: The amount of infant breath moments recorded per minute during the feeding session. It is expressed in breaths per minute (bpm) and reflects the respiratory function and oxygenation of the infant.
Inspirium After Swallow Count
Time frame: 1-7 day
Description: Number of detected inspirium after swallowing events in a feeding session. This parameter is analyzed in two groups: inspiriums that overlap with swallow events and inspiriums that do not overlap with swallows but the interval in between is too short which may lead to aspiration. The total number of Inspirium After Swallow 's is obtained by summing these two groups.
Overlapped Inspirium After Swallow Events: Overlapped Inspirium After Swallow Percentage & Average Overlapped Inspirium After Swallow Duration
Time frame: 1-7 day
Description: Overlapped Inspirium After Swallow events represent the number of inspirium states that overlap with swallows. The overlapped Inspirium After Swallow percentage expresses the average percentage of the ratio of the overlap time to total swallow time, whereas the average overlapped Inspirium After Swallow duration represents the average duration of the overlapping inspirium with swallows. These parameters can be better understood with numerical examples, as in the following sections.
Maximum Rhythmic Swallow
Time frame: 1-7 day
Description: The maximum number of swallows that the infant can perform in a rhythmic cycle without a resting interval. This parameter represents the number of swallows in the longest rhythmic cycle that the infant demonstrates. It indicates how well the infant can swallow without requiring rest intervals. A higher number suggests that the infant can swallow more smoothly and effectively, while a lower number indicates the need for more rest intervals between swallows.
Minimum Rhythmic Swallow
Time frame: 1-7 day
Description: The minimum number of swallows that the infant can perform in a rhythmic cycle without any rest interval. This parameter reflects the infant's swallowing consistency and stability. A higher value indicates the infant can maintain a regular swallowing pattern, while a lower value implies more variability in their swallowing rhythm.
Average Time Between Rhythmic Swallows
Time frame: 1-7 day
Description: The average time of the intervals between consecutive rhythmic swallow groups. This parameter shows the infant's resting behavior. A longer interval indicates that the infant takes more extended breaks between the rhythmic swallow events, while a shorter interval suggests the infant swallows more rapidly and smoothly.
Resting Interval Count
Time frame: 1-7 day
Description: Total number of rest intervals when rhythmic swallowing is not observed.
1 secondary outcome
Preterm Infant Oral Feeding Readiness
Time frame: 1-7 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The PIOMI initiative in maternal interaction in people with Preterm and Preterm Infant Development, 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Swallow Count (time frame: 1-7 day). The study lists 8 primary outcomes in all. 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 26 Oct 2026.