PrematurityNCT07366190
PIOMI Effects on Preterm Infant Outcomes
A study testing Premature Infant Oral Motor Intervention (PIOMI) and nursing care in people with Prematurity, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aimed to investigate the effects of Premature Infant Oral Motor Intervention (PIOMI) on body weight gain, breastfeeding behavior, and length of hospital stay in preterm infants hospitalized in the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Ages 24 to 30 weeksHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- Premature Infant Oral Motor Intervention (PIOMI) and nursing care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Jul 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 24 to 30 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age between 26 and 30 weeks,
- Minimum birth weight of 1350 grams,
- Physical stability during oral stimulation,
- Apgar score of 4 or above at 5 minutes after birth.
Who cannot join
- Presence of congenital anomalies or chromosomal abnormalities,
- Chronic medical conditions such as bronchopulmonary dysplasia,
- Intraventricular hemorrhage (Grade III or IV),
- Necrotizing enterocolitis (NEC),
- Asphyxia and seizures,
- Treatments related to neonatal jaundice requiring exchange transfusion or blood transfusion,
- Sepsis confirmed by positive blood culture.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Konya, 40336
About this study
Official title: Effects of Premature Infant Oral Motor Intervention (PIOMI) on Feeding Behavior, Weight Gain, and Length of Hospital Stay in Preterm Infants: A Randomized Controlled Trial
Objective: This study aimed to investigate the effects of Premature Infant Oral Motor Intervention (PIOMI) on body weight gain, breastfeeding behavior, and length of hospital stay in preterm infants hospitalized in the neonatal intensive care unit (NICU).
Methods: A randomized controlled experimental study design was used. A total of 32 preterm infants with gestational age between 26-30 weeks were randomly assigned to the intervention group (n=16) or control group (n=16). The intervention group received PIOMI twice daily for 7 consecutive days (14 sessions in total), while the control group received routine care only. The Premature Infant Breastfeeding Behavior Scale (PIBBS) was used to evaluate breastfeeding performance before and after the intervention. Weight changes and length of hospital stay were recorded and compared between groups.
Read the detailed description
Objective
This study aimed to investigate the effects of Premature Infant Oral Motor Intervention (PIOMI) on feeding behavior, weight gain, and length of hospital stay in preterm infants hospitalized in the neonatal intensive care unit (NICU).
Methods
This study was designed as a randomized controlled experimental trial with a pretest-posttest parallel-group design. A total of 32 preterm infants with a gestational age between 26 and 30 weeks were randomly assigned to either the intervention group (n = 16) or the control group (n = 16). The intervention group received Premature Infant Oral Motor Intervention (PIOMI) twice daily for 7 consecutive days (14 sessions in total), while the control group received routine nursing care only. Breastfeeding behavior was assessed using the Premature Infant Breastfeeding Behavior Scale (PIBBS) before and after the intervention. Body weight was measured daily, and total weight gain and length of hospital stay were recorded. Statistical analyses were performed using appropriate parametric and non-parametric tests according to data distribution, with a significance level set at p < 0.05.
Conclusion
This study was designed to evaluate the clinical effects of PIOMI on feeding performance, weight gain, and hospitalization outcomes in preterm infants.
- Conditions
- Prematurity
- Being tested
- Premature Infant Oral Motor Intervention (PIOMI), nursing care
- Keywords
- Premature infant, PIOMI, breastfeeding behavior, weight gain, neonatal intensive care
- Medical subject headings
- Premature Birth, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premature Infant Oral Motor Intervention (PIOMI)Other
The Beckman Oral Motor Intervention (BOMI) was redesigned by Dr. Brenda Lessen, modifying its duration and steps, to create the Premature Infant Oral Motor Intervention (PIOMI). PIOMI is the only preterm oral motor intervention that can be consistently and reliably applied and easily taught through a specific training program.In the intervention group, physiotherapists administered PIOMI, which consisted of cheek support, lip rounding, lip closure, gum massage, pressure on the lateral and anterior tip of the tongue, and palate tapping to stimulate sucking. The intervention lasted 3 minutes, followed by 2 minutes of non-nutritive sucking, administered twice daily for 7 consecutive days (each session lasting 5 minutes). Oxygen saturation and heart rate were monitored during the application.
nursing careOther
The control group received routine nursing care without any additional oral motor stimulation.
| Study group | Role | What they receive |
|---|---|---|
| PIOMI | Experimental | The PIBBS evaluates six sub-items: latching onto the breast, areola grasp, securing the breast with the mandible, sucking, longest sucking burst, and swallowing. Total scores were documented.
In the intervention group, physiotherapists administered PIOMI, which consisted of cheek support, lip rounding, lip closure, gum massage, pressure on the lateral and anterior tip of the tongue, and palate tapping to stimulate sucking. The intervention lasted 3 minutes, followed by 2 minutes of non-nutritive sucking, administered twice daily for 7 consecutive days (each session lasting 5 minutes). Oxygen saturation and heart rate were monitored during the application. Receives: Other: Premature Infant Oral Motor Intervention (PIOMI) |
| Control | Other | The control group received routine nursing care without any additional oral motor stimulation. Receives: Other: nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Breastfeeding Behavior Scale (PIBBS).
The PIBBS evaluates six sub-items: latching onto the breast, areola grasp, securing the breast with the mandible, sucking, longest sucking burst, and swallowing. Total scores were documented.The Premature Infant Breastfeeding Behavior Scale (PIBBS) evaluates six sub-items: latching onto the breast, areola grasp, securing the breast with the mandible, sucking, longest sucking burst, and swallowing.
The total score ranges from 0 to 20, with higher scores indicating better breastfeeding performance.
Measured: Baseline (pre-intervention) and Day 7 (post-intervention)
discharge weight
Change in body weight from baseline to discharge
Measured: From baseline (pre-intervention) to day 7 after completion of the intervention
Length of Hospital Stay
Length of hospital stay is defined as the total number of days from admission to the neonatal intensive care unit (NICU) until hospital discharge.
Measured: From NICU admission (baseline) until hospital discharge, assessed up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Dec 2024
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment interventional model. Eligible preterm infants are randomly assigned to either the intervention group receiving Premature Infant Oral Motor Intervention (PIOMI) or to a control group receiving standard care. Both groups are followed concurrently throughout the study period, and outcome measures are assessed at baseline and after the intervention.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Altuntas Yilmaz, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366190
- Sponsor's protocol ID
- NEU-PT2025-04
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical restrictions and the vulnerable nature of the study population (preterm infants). Data contain sensitive clinical information, and sharing individual-level data could compromise participant confidentiality despite anonymization. Therefore, individual patient data will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Premature Infant Oral Motor Intervention (PIOMI) on Feeding Behavior, Weight Gain, and Length of Hospital Stay in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07366190
- Acronym / sponsor ID
- NEU-PT2025-04
- Conditions
- Prematurity
- Keywords
- Premature infant, PIOMI, breastfeeding behavior, weight gain, neonatal intensive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 26 Jan 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.
Objective: This study aimed to investigate the effects of Premature Infant Oral Motor Intervention (PIOMI) on body weight gain, breastfeeding behavior, and length of hospital stay in preterm infants hospitalized in the neonatal intensive care unit (NICU).
Methods: A randomized controlled experimental study design was used. A total of 32 preterm infants with gestational age between 26-30 weeks were randomly assigned to the intervention group (n=16) or control group (n=16). The intervention group received PIOMI twice daily for 7 consecutive days (14 sessions in total), while the control group received routine care only. The Premature Infant Breastfeeding Behavior Scale (PIBBS) was used to evaluate breastfeeding performance before and after the intervention. Weight changes and length of hospital stay were recorded and compared between groups.
Detailed description
Objective
This study aimed to investigate the effects of Premature Infant Oral Motor Intervention (PIOMI) on feeding behavior, weight gain, and length of hospital stay in preterm infants hospitalized in the neonatal intensive care unit (NICU).
Methods
This study was designed as a randomized controlled experimental trial with a pretest-posttest parallel-group design. A total of 32 preterm infants with a gestational age between 26 and 30 weeks were randomly assigned to either the intervention group (n = 16) or the control group (n = 16). The intervention group received Premature Infant Oral Motor Intervention (PIOMI) twice daily for 7 consecutive days (14 sessions in total), while the control group received routine nursing care only. Breastfeeding behavior was assessed using the Premature Infant Breastfeeding Behavior Scale (PIBBS) before and after the intervention. Body weight was measured daily, and total weight gain and length of hospital stay were recorded. Statistical analyses were performed using appropriate parametric and non-parametric tests according to data distribution, with a significance level set at p < 0.05.
Conclusion
This study was designed to evaluate the clinical effects of PIOMI on feeding performance, weight gain, and hospitalization outcomes in preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment interventional model. Eligible preterm infants are randomly assigned to either the intervention group receiving Premature Infant Oral Motor Intervention (PIOMI) or to a control group receiving standard care. Both groups are followed concurrently throughout the study period, and outcome measures are assessed at baseline and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| PIOMI | Experimental | Other: Premature Infant Oral Motor Intervention (PIOMI)The PIBBS evaluates six sub-items: latching onto the breast, areola grasp, securing the breast with the mandible, sucking, longest sucking burst, and swallowing. Total scores were documented. In the intervention group, physiotherapists administered PIOMI, which consisted of cheek support, lip rounding, lip closure, gum massage, pressure on the lateral and anterior tip of the tongue, and palate tapping to stimulate sucking. The intervention lasted 3 minutes, followed by 2 minutes of non-nutritive sucking, administered twice daily for 7 consecutive days (each session lasting 5 minutes). Oxygen saturation and heart rate were monitored during the application. |
| Control | Other | Other: nursing careThe control group received routine nursing care without any additional oral motor stimulation. |
Who may qualify
- Ages
- 24 to 30 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age between 26 and 30 weeks,
- Minimum birth weight of 1350 grams,
- Physical stability during oral stimulation,
- Apgar score of 4 or above at 5 minutes after birth.
Key exclusion criteria (7 listed)
- Presence of congenital anomalies or chromosomal abnormalities,
- Chronic medical conditions such as bronchopulmonary dysplasia,
- Intraventricular hemorrhage (Grade III or IV),
- Necrotizing enterocolitis (NEC),
- Asphyxia and seizures,
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 |
|---|---|---|
| Premature Infant Oral Motor Intervention (PIOMI)The Beckman Oral Motor Intervention (BOMI) was redesigned by Dr. Brenda Lessen, modifying its duration and steps, to create the Premature Infant Oral Motor Intervention (PIOMI). PIOMI is the only preterm oral motor intervention that can be consistently and reliably applied and easily taught through a specific training program.In the intervention group, physiotherapists administered PIOMI, which consisted of cheek support, lip rounding, lip closure, gum massage, pressure on the lateral and anterior tip of the tongue, and palate tapping to stimulate sucking. The intervention lasted 3 minutes, followed by 2 minutes of non-nutritive sucking, administered twice daily for 7 consecutive days (each session lasting 5 minutes). Oxygen saturation and heart rate were monitored during the application. | Other | PIOMI |
| nursing careThe control group received routine nursing care without any additional oral motor stimulation. | Other | Control |
Primary outcome
Premature Infant Breastfeeding Behavior Scale (PIBBS).
Time frame: Baseline (pre-intervention) and Day 7 (post-intervention)
The PIBBS evaluates six sub-items: latching onto the breast, areola grasp, securing the breast with the mandible, sucking, longest sucking burst, and swallowing. Total scores were documented.The Premature Infant Breastfeeding Behavior Scale (PIBBS) evaluates six sub-items: latching onto the breast, areola grasp, securing the breast with the mandible, sucking, longest sucking burst, and swallowing. The total score ranges from 0 to 20, with higher scores indicating better breastfeeding performance.
discharge weight
Time frame: From baseline (pre-intervention) to day 7 after completion of the intervention
Change in body weight from baseline to discharge
Length of Hospital Stay
Time frame: From NICU admission (baseline) until hospital discharge, assessed up to 8 weeks
Length of hospital stay is defined as the total number of days from admission to the neonatal intensive care unit (NICU) until hospital discharge.
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 26 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical restrictions and the vulnerable nature of the study population (preterm infants). Data contain sensitive clinical information, and sharing individual-level data could compromise participant confidentiality despite anonymization. Therefore, individual patient data will not be made publicly available.
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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 Premature Infant Oral Motor Intervention (PIOMI) and nursing care in people with Prematurity, run by Necmettin Erbakan 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 7 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 26 Jan 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?
Premature Infant Breastfeeding Behavior Scale (PIBBS). (time frame: Baseline (pre-intervention) and Day 7 (post-intervention)). The study lists 3 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 Jan 2026.