PrematureNCT06194513
Oral Motor Intervention to Preterms by Their Mothers
A study testing Intervention 1: Twice a day for 1 week PIOMI and Intervention 2: Once a day for 2 weeks PIOMI in people with Premature, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Babies who have been discharged from the neonatal intensive care unit and have difficulty in oral feeding will be identified. Oral Motor Intervention (PIOMI) will be taught to the mothers of these babies and asked to practice. Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Premature
- What is being tested?
- Intervention 1: Twice a day for 1 week PIOMI and Intervention 2: Once a day for 2 weeks PIOMI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 29 Feb 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 Up to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participation in the study is accepted by the family
- PIOMI can be applied and whose clinical condition is stable,
- Born earlier than 37 weeks,
- Those who have not been diagnosed with any disorder in swallowing functions,
- Without congenital anomalies and systemic diseases,
- Vital signs are stable,
- Babies without congenital anomalies or serious complications
Who cannot join
- Participation in the study is not accepted by their family,
- Those with congenital anomalies and systemic diseases.
- Those who have been diagnosed with swallowing disorder,
- Those with congenital disorders or birth trauma,
- Diagnosed with severe asphyxia,
- Those with intraventricular bleeding,
Show all 9Show fewer
- Those with Neonatal Abstinence Syndrome,
- Those with Fetal Alcohol Syndrome,
- Babies connected to a ventilator
Trial locations and contacts
1 site in 1 country.
Evrim Karadag Saygi, Prof contact
Turkey (Türkiye)1 site
Marmara University
Istanbul, Maltepe, 34854
Evrim Karadag Saygi, Prof
About this study
Official title: Examining the Effect of Oral Motor Intervention Applied to Preterm Babies by Their Mothers at Different Frequencies on Oral Feeding Performance and Mother Baby Bonding
Babies who have been discharged from the neonatal intensive care unit and have difficulty in oral feeding will be identified. Oral Motor Intervention (PIOMI) will be taught to the mothers of these babies and asked to practice. As a result of this application, the change in oral feeding skills in babies and its effect on mother-infant bonding will be evaluated.
Read the detailed description
The aim of this study is to observe the changes in babies' oral feeding skills and mothers' mother-baby attachment evaluation status as a result of oral motor intervention (PIOMI) applied to preterms with oral feeding difficulties.
An estimated 20 million babies are born preterm (before the 37th week of gestation) each year in the world, and this number is increasing, and complications of prematurity are among the leading causes of death among children under 5 years of age. Three-quarters of these deaths are preventable with current, cost-effective interventions.
Problems experienced after discharge include delayed feeding ability, food rejection, difficulty in transitioning to solid foods, and slowdown in growth. The reasons that lead to these difficulties are; These are post-discharge health problems such as immaturity, parenteral or tube feeding as opposed to oral motor experience, and neurological or cognitive disorders. All of these make it difficult for the child to develop nutritional skills and cause stress, depression, and self-confidence in the family.
Premature Infant Oral Motor Intervention (PIOMI) is a five-minute, eight-step oral motor intervention applied to preterm infants that aims to mimic the in utero oral experience that strengthens and improves feeding mechanisms. PIOMI provides assisted movement to activate muscle contraction for suckling and oral feeding, generating force to move against resistance, increasing functional response to pressure. It improves control of movements in accordance with a specific protocol that includes light contact with fingertips on the lips, cheeks, chin, gums, palate and tongue for the first three minutes, and pacifier/thumb sucking for the last two minutes. It was developed by Lessen BS to provide oral motor stimulation in preterm babies and its reliability study was conducted. The Turkish adaptation of the application was made by Selver Güler and Zerrin Çiğdem in 2021.
This oral motor intervention will be taught to the mother by a physiotherapist trained in this field, and it is planned that the mother will perform the application. In this way, premature babies with low immunity will not risk their health and will be given the opportunity to be treated more safely at home rather than in a hospital environment, which will save time and money. The effect of oral motor intervention frequency on oral motor skills will also be examined through applications at different frequencies.
Before the applications and after all the applications are completed, LATCH (Breastfeeding Assessment Tool) and POFRAS (Oral Feeding Readiness Assessment Scale in Preterm Babies) are filled in by the physiotherapist to evaluate the oral motor skills of the babies, and ABBÖ (Mother Baby Attachment Scale) is filled in by the mother to observe the mother-baby attachment status.
Preterm (<37 weeks of gestation) and babies with a corrected age of up to 3 months will be evaluated. Medical records and demographic data of the babies, whose verbal and written consent has been obtained from their parents, will be collected and PIOMI will be applied to the babies in the intervention groups by their mothers at different frequencies (twice a day for 1 week, once a day for 2 weeks). In addition to these two groups, there will be a control group and the evaluation results of the 3 groups will be examined. It is planned to apply different frequencies to the babies in Groups 1 and 2. and Group 3/Control group will be given oral activation only with a pacifier for 14 days.
The sample size of this study was calculated using the G*Power 3.1.9.2 program. In the analysis, there was a medium effect size (f = 0.25), Type I α = 0.05 and 80% power, which should be included in each group. The number of participants was calculated as 42 people in total, 14 people per group.
With this thesis, the investigators aim to shed light on future studies by contributing to the literature and to observe the positive effect of this situation on both the baby and the mother by initiating an oral motor intervention in which the mother can directly participate in the treatment.
- Conditions
- Premature
- Being tested
- Intervention 1: Twice a day for 1 week PIOMI, Intervention 2: Once a day for 2 weeks PIOMI
- Keywords
- The Motor to Infant Bonding Scale, Preterm Infant Oral Feeding Readiness Assessment, The Breastfeeding Assessment Tool
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: Twice a day for 1 week PIOMIOther
Preterm babies will receive two sessions of treatment every day for a week, for a total of 14 sessions. Each session will be five minutes. The application is done at a time when the baby is peaceful and not very hungry. When the application is performed, the baby is positioned on his back and in a way that feels comfortable.
Intervention 2: Once a day for 2 weeks PIOMIOther
Preterm babies will receive a total of 14 sessions of treatment, one every day for two weeks. Each session will be five minutes. The application is done at a time when the baby is peaceful and not very hungry. When the application is performed, the baby is positioned on his back and in a way that feels comfortable.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1: Twice a day for 1 week PIOMI | Experimental | Mothers of preterm babies in this group who have oral feeding difficulties will be taught Oral Motor Intervention (PIOMI) and asked to apply it. During the applications, visual monitoring of the application will be provided via video call, and objective monitoring of the application will be provided with the PIOMI Reliability Assessment Tool. Receives: Other: Intervention 1: Twice a day for 1 week PIOMI |
| Intervention 2: Once a day for 2 weeks PIOMI | Experimental | Mothers of preterm babies in this group who have oral feeding difficulties will be taught Oral Motor Intervention (PIOMI) and asked to apply it. During the applications, visual monitoring of the application will be provided via video call, and objective monitoring of the application will be provided with the PIOMI Reliability Assessment Tool. Receives: Other: Intervention 2: Once a day for 2 weeks PIOMI |
| Control | No intervention | In the control group, no extra intervention will be given to preterm babies who have difficulty in oral feeding, and oral activation will be provided only with a pacifier. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The LATCH Breastfeeding Assessment Tool (Latch Audible Swallowing, Type of Nipple, Comfort of Breast/Nipple, H-Hold/ Position)
LATCH is a tool created by analogy with the Apgar score system in terms of scoring method, and its evaluation is quick and easy.
The Turkish validity of the Assessment Tool was conducted by Demirhan in 1997, Koyun in 2001, and Yenal and Okumuş in 2003, and it was recommended to be used as a reliable tool. The highest score that can be obtained from the scale is 10 and the lowest score is 0. Increasing scores from the scale indicate breastfeeding success. Cronbach Alpha value of the LATCH Breastfeeding Assessment Tool; Yenal and Okumuş found it as 0.95, Demirhan as 0.94, and Koyun as 0.96.
The scale considers mother and baby together. It can be evaluated by a healthcare professional or the mother. In the evaluation; It includes the criteria for breast retention, the baby's swallowing movement, the type of nipple, the mother's comfort with the breast and nipple, and the position of holding the baby.
Measured: 0, 7. day, 14. day
Preterm Infant Oral Feeding Readiness Assessment (PIOFRA/ POFRAS)
This scale consists of 5 categories (corrected gestational age, behavioral organization, mouth posture, oral reflexes, non-nutritive sucking) and 18 items and evaluates readiness for oral feeding in preterm infants. The scale is scored between 0-2 and the maximum score is 36. The cut-off point for switching a preterm baby to oral feeding was determined as 30 .
Turkish Validity-Reliability: In the Turkish adaptation of this scale made by Çamur and Çetinkaya in 2020, the cut-off point was found to be 29.
Measured: 0, 7. day, 14. day
Secondary outcomes (1)
The Mother to Infant Bonding Scale (MIBS)
The scale is designed to be applied from the first day after birth and allows the mother to express her feelings towards her baby with a single word. This scale, which can be easily and quickly applied by the mother and father alone, shows the relationship between the bond established and the mother's early mood.
MIBS is a 4-point Likert scale consisting of 8 items. Responses consisting of four options are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 24. In the evaluation, the 1st, 4th, and 6th items express positive emotions and are scored as 0, 1, 2, 3, while the 2nd, 3rd, 5th, 7th items are scored as 0, 1, 2, 3. Items 1 and 8 are expressions of negative emotions and are scored in reverse, as 3, 2, 1, 0.
Measured: 0, 7. day, 14. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start10 Jan 2024 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The infants included in the study will be divided to 3 groups and will be treated at the same time as a control group and 2 treatment groups.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aylin Demirci, PT, Principal investigator, Marmara UniversityEvrim Karadag Saygi, Prof, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194513
- Sponsor's protocol ID
- 09.2023.1690
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hegazy SM. Late Preterm Infants. A Guide for Nurses, Midwives, Clinicians, and Allied Health Professionals. Saudi Med J. 2019 Dec;40(12):1303. doi: 10.15537/smj.2019.12.24665.
PubMed 31828286Cerro N, Zeunert S, Simmer KN, Daniels LA. Eating behaviour of children 1.5-3.5 years born preterm: parents' perceptions. J Paediatr Child Health. 2002 Feb;38(1):72-8. doi: 10.1046/j.1440-1754.2002.00728.x.
PubMed 11869405Gewolb IH, Vice FL. Maturational changes in the rhythms, patterning, and coordination of respiration and swallow during feeding in preterm and term infants. Dev Med Child Neurol. 2006 Jul;48(7):589-94. doi: 10.1017/S001216220600123X.
PubMed 16780629Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
PubMed 8176525Fujinaga CI, de Moraes SA, Zamberlan-Amorim NE, Castral TC, de Almeida e Silva A, Scochi CG. Clinical validation of the Preterm Oral Feeding Readiness Assessment Scale. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:140-5. doi: 10.1590/s0104-11692013000700018. English, Portuguese.
PubMed 23459901
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Oral Motor Intervention Applied to Preterm Babies by Their Mothers at Different Frequencies on Oral Feeding Performance and Mother Baby Bonding
- ClinicalTrials.gov ID
- NCT06194513
- Acronym / sponsor ID
- 09.2023.1690
- Conditions
- Premature
- Keywords
- The Motor to Infant Bonding Scale, Preterm Infant Oral Feeding Readiness Assessment, The Breastfeeding Assessment Tool
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 8 Jan 2024 (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.
Babies who have been discharged from the neonatal intensive care unit and have difficulty in oral feeding will be identified. Oral Motor Intervention (PIOMI) will be taught to the mothers of these babies and asked to practice. As a result of this application, the change in oral feeding skills in babies and its effect on mother-infant bonding will be evaluated.
Detailed description
The aim of this study is to observe the changes in babies' oral feeding skills and mothers' mother-baby attachment evaluation status as a result of oral motor intervention (PIOMI) applied to preterms with oral feeding difficulties.
An estimated 20 million babies are born preterm (before the 37th week of gestation) each year in the world, and this number is increasing, and complications of prematurity are among the leading causes of death among children under 5 years of age. Three-quarters of these deaths are preventable with current, cost-effective interventions.
Problems experienced after discharge include delayed feeding ability, food rejection, difficulty in transitioning to solid foods, and slowdown in growth. The reasons that lead to these difficulties are; These are post-discharge health problems such as immaturity, parenteral or tube feeding as opposed to oral motor experience, and neurological or cognitive disorders. All of these make it difficult for the child to develop nutritional skills and cause stress, depression, and self-confidence in the family.
Premature Infant Oral Motor Intervention (PIOMI) is a five-minute, eight-step oral motor intervention applied to preterm infants that aims to mimic the in utero oral experience that strengthens and improves feeding mechanisms. PIOMI provides assisted movement to activate muscle contraction for suckling and oral feeding, generating force to move against resistance, increasing functional response to pressure. It improves control of movements in accordance with a specific protocol that includes light contact with fingertips on the lips, cheeks, chin, gums, palate and tongue for the first three minutes, and pacifier/thumb sucking for the last two minutes. It was developed by Lessen BS to provide oral motor stimulation in preterm babies and its reliability study was conducted. The Turkish adaptation of the application was made by Selver Güler and Zerrin Çiğdem in 2021.
This oral motor intervention will be taught to the mother by a physiotherapist trained in this field, and it is planned that the mother will perform the application. In this way, premature babies with low immunity will not risk their health and will be given the opportunity to be treated more safely at home rather than in a hospital environment, which will save time and money. The effect of oral motor intervention frequency on oral motor skills will also be examined through applications at different frequencies.
Before the applications and after all the applications are completed, LATCH (Breastfeeding Assessment Tool) and POFRAS (Oral Feeding Readiness Assessment Scale in Preterm Babies) are filled in by the physiotherapist to evaluate the oral motor skills of the babies, and ABBÖ (Mother Baby Attachment Scale) is filled in by the mother to observe the mother-baby attachment status.
Preterm (<37 weeks of gestation) and babies with a corrected age of up to 3 months will be evaluated. Medical records and demographic data of the babies, whose verbal and written consent has been obtained from their parents, will be collected and PIOMI will be applied to the babies in the intervention groups by their mothers at different frequencies (twice a day for 1 week, once a day for 2 weeks). In addition to these two groups, there will be a control group and the evaluation results of the 3 groups will be examined. It is planned to apply different frequencies to the babies in Groups 1 and 2. and Group 3/Control group will be given oral activation only with a pacifier for 14 days.
The sample size of this study was calculated using the G*Power 3.1.9.2 program. In the analysis, there was a medium effect size (f = 0.25), Type I α = 0.05 and 80% power, which should be included in each group. The number of participants was calculated as 42 people in total, 14 people per group.
With this thesis, the investigators aim to shed light on future studies by contributing to the literature and to observe the positive effect of this situation on both the baby and the mother by initiating an oral motor intervention in which the mother can directly participate in the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The infants included in the study will be divided to 3 groups and will be treated at the same time as a control group and 2 treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention 1: Twice a day for 1 week PIOMI | Experimental | Other: Intervention 1: Twice a day for 1 week PIOMIMothers of preterm babies in this group who have oral feeding difficulties will be taught Oral Motor Intervention (PIOMI) and asked to apply it. During the applications, visual monitoring of the application will be provided via video call, and objective monitoring of the application will be provided with the PIOMI Reliability Assessment Tool. |
| Intervention 2: Once a day for 2 weeks PIOMI | Experimental | Other: Intervention 2: Once a day for 2 weeks PIOMIMothers of preterm babies in this group who have oral feeding difficulties will be taught Oral Motor Intervention (PIOMI) and asked to apply it. During the applications, visual monitoring of the application will be provided via video call, and objective monitoring of the application will be provided with the PIOMI Reliability Assessment Tool. |
| Control | No intervention | –In the control group, no extra intervention will be given to preterm babies who have difficulty in oral feeding, and oral activation will be provided only with a pacifier. |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participation in the study is accepted by the family
- PIOMI can be applied and whose clinical condition is stable,
- Born earlier than 37 weeks,
- Those who have not been diagnosed with any disorder in swallowing functions,
- Without congenital anomalies and systemic diseases,
Key exclusion criteria (9 listed)
- Participation in the study is not accepted by their family,
- Those with congenital anomalies and systemic diseases.
- Those who have been diagnosed with swallowing disorder,
- Those with congenital disorders or birth trauma,
- Diagnosed with severe asphyxia,
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 |
|---|---|---|
| Intervention 1: Twice a day for 1 week PIOMIPreterm babies will receive two sessions of treatment every day for a week, for a total of 14 sessions. Each session will be five minutes. The application is done at a time when the baby is peaceful and not very hungry. When the application is performed, the baby is positioned on his back and in a way that feels comfortable. | Other | Intervention 1: Twice a day for 1 week PIOMI |
| Intervention 2: Once a day for 2 weeks PIOMIPreterm babies will receive a total of 14 sessions of treatment, one every day for two weeks. Each session will be five minutes. The application is done at a time when the baby is peaceful and not very hungry. When the application is performed, the baby is positioned on his back and in a way that feels comfortable. | Other | Intervention 2: Once a day for 2 weeks PIOMI |
Primary outcome
The LATCH Breastfeeding Assessment Tool (Latch Audible Swallowing, Type of Nipple, Comfort of Breast/Nipple, H-Hold/ Position)
Time frame: 0, 7. day, 14. day
LATCH is a tool created by analogy with the Apgar score system in terms of scoring method, and its evaluation is quick and easy. The Turkish validity of the Assessment Tool was conducted by Demirhan in 1997, Koyun in 2001, and Yenal and Okumuş in 2003, and it was recommended to be used as a reliable tool. The highest score that can be obtained from the scale is 10 and the lowest score is 0. Increasing scores from the scale indicate breastfeeding success. Cronbach Alpha value of the LATCH Breastfeeding Assessment Tool; Yenal and Okumuş found it as 0.95, Demirhan as 0.94, and Koyun as 0.96. The scale considers mother and baby together. It can be evaluated by a healthcare professional or the mother. In the evaluation; It includes the criteria for breast retention, the baby's swallowing movement, the type of nipple, the mother's comfort with the breast and nipple, and the position of holding the baby.
Preterm Infant Oral Feeding Readiness Assessment (PIOFRA/ POFRAS)
Time frame: 0, 7. day, 14. day
This scale consists of 5 categories (corrected gestational age, behavioral organization, mouth posture, oral reflexes, non-nutritive sucking) and 18 items and evaluates readiness for oral feeding in preterm infants. The scale is scored between 0-2 and the maximum score is 36. The cut-off point for switching a preterm baby to oral feeding was determined as 30 . Turkish Validity-Reliability: In the Turkish adaptation of this scale made by Çamur and Çetinkaya in 2020, the cut-off point was found to be 29.
1 secondary outcome
The Mother to Infant Bonding Scale (MIBS)
Time frame: 0, 7. day, 14. day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Background: PubMed 31828286Hegazy SM. Late Preterm Infants. A Guide for Nurses, Midwives, Clinicians, and Allied Health Professionals. Saudi Med J. 2019 Dec;40(12):1303. doi: 10.15537/smj.2019.12.24665.
- Background: PubMed 11869405Cerro N, Zeunert S, Simmer KN, Daniels LA. Eating behaviour of children 1.5-3.5 years born preterm: parents' perceptions. J Paediatr Child Health. 2002 Feb;38(1):72-8. doi: 10.1046/j.1440-1754.2002.00728.x.
- Background: PubMed 16780629Gewolb IH, Vice FL. Maturational changes in the rhythms, patterning, and coordination of respiration and swallow during feeding in preterm and term infants. Dev Med Child Neurol. 2006 Jul;48(7):589-94. doi: 10.1017/S001216220600123X.
- Background: PubMed 8176525Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
- Background: PubMed 23459901Fujinaga CI, de Moraes SA, Zamberlan-Amorim NE, Castral TC, de Almeida e Silva A, Scochi CG. Clinical validation of the Preterm Oral Feeding Readiness Assessment Scale. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:140-5. doi: 10.1590/s0104-11692013000700018. English, Portuguese.
- 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.
Evrim Karadag Saygi, Prof contact
Aylin Demirci, PT principal investigator
Marmara University
Evrim Karadag Saygi, Prof study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1: Twice a day for 1 week PIOMI and Intervention 2: Once a day for 2 weeks PIOMI in people with Premature, run by Marmara 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 8 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aylin Demirci, PT (+905423228612, fzt.aylindemirci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The LATCH Breastfeeding Assessment Tool (Latch Audible Swallowing, Type of Nipple, Comfort of Breast/Nipple, H-Hold/ Position) (time frame: 0, 7. day, 14. day). The study lists 2 primary outcomes in all. 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 NCT06194513, which also lists 5 linked publications.
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 8 Jan 2024.