SwallowNCT06208228
Effect of Kinesio-taping Technique on Oral Feeding in Late Preterm Infants
A study testing Kinesiotaping in people with Swallow and Preterm Infant, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Difficulty in feeding among late preterm infants is one of the most significant factors contributing to prolonged hospitalization and re-admissions. By providing support to the sucking and swallowing muscles early in their development, the maturation process can be expedited, allowing for the safe early discharge of… Read more about this study
- Who is it for?
- Ages 1 month to 4 months
- Conditions the study is for
- Swallow, Preterm Infant, Newborn
- What is being tested?
- Kinesiotaping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 31 Dec 2018
- 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 1 month to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born in Baskent University Ankara Hospital,
- age between 34-36.6 weeks
Who cannot join
- Infants with multiple kongenital anomaly,
- hypoxic ischemic encephalopathy,
- intraventricular and intracranial hemorrhage,
- necrotizing enterocolitis,
- tracheoesophageal fistula,
- diaphragmatic hernia,
- hydrocephalus,
- respiratory distress.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kinesio-taping Technique on Oral Feeding and Swallowing Functions: An Acoustic Analysis of Swallowing Sound in Late Preterm Infants
Difficulty in feeding among late preterm infants is one of the most significant factors contributing to prolonged hospitalization and re-admissions. By providing support to the sucking and swallowing muscles early in their development, the maturation process can be expedited, allowing for the safe early discharge of preterm infants.
This study aims to investigate the effects of the Kinesio taping technique on feeding muscles and assess feeding and swallowing function in late preterm infants using acoustic analysis of swallowing sounds.
Read the detailed description
Problems such as poor nutrition, weak sucking, lack of suck-swallow-respiration coordination, low weight gain are among the factors increasing the risk of morbidity in late preterm infants. Early support of sucking and swallowing muscles for the development of suck-swallow coordination can shorten the maturation process and provide early discharge of late preterm infants. The aim of this study is to document kinesiotape technique to support sucking and swallowing muscles for treating nutritional problems and for reducing nutrition risks and accelerating maturation. According to power of analysis of this study, 74 infants planned to assign to kinesiotaping group or control group randomly. In kinesiotaping group, infants feeding performance will be evaluated by measuring the amount of milk invested, maximum heart rate, oxygen saturation, speed of milk intake and counting the number of swallow during feeding. Kinesiotape will be applied to masseter and hyoid muscles 24 hours later after the birth of the infant. Infants will be evaluated before kinesiotape application, 3 hour later and 24 hour later after the application.
- Conditions
- Swallow, Preterm Infant, Newborn, Kinesiotaping, Sucking
- Being tested
- Kinesiotaping
- Keywords
- swallow, preterm infant, newborn, kinesiotaping, sucking
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingDevice
Kinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing.
| Study group | Role | What they receive |
|---|---|---|
| kinesiotape | Experimental | Kinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing. Receives: Device: Kinesiotaping |
| Control | No intervention | In this group the late preterm infants won't be applied kinesiotaping to suck and swallow muscles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of swallows of the baby during feeding
digital stethoscope
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SwallowStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Comuk Balci, Ondokuz Mayıs University
- Investigators
- Nilay Comuk Balci, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208228
- Sponsor's protocol ID
- KA18/36
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If requested, then the investigators could share the IPD
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio-taping Technique on Oral Feeding and Swallowing Functions: An Acoustic Analysis of Swallowing Sound in Late Preterm Infants
- ClinicalTrials.gov ID
- NCT06208228
- Acronym / sponsor ID
- KA18/36
- Conditions
- Swallow, Preterm Infant, Newborn, Kinesiotaping, Sucking
- Keywords
- swallow, preterm infant, newborn, kinesiotaping, sucking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 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.
Difficulty in feeding among late preterm infants is one of the most significant factors contributing to prolonged hospitalization and re-admissions. By providing support to the sucking and swallowing muscles early in their development, the maturation process can be expedited, allowing for the safe early discharge of preterm infants.
This study aims to investigate the effects of the Kinesio taping technique on feeding muscles and assess feeding and swallowing function in late preterm infants using acoustic analysis of swallowing sounds.
Detailed description
Problems such as poor nutrition, weak sucking, lack of suck-swallow-respiration coordination, low weight gain are among the factors increasing the risk of morbidity in late preterm infants. Early support of sucking and swallowing muscles for the development of suck-swallow coordination can shorten the maturation process and provide early discharge of late preterm infants. The aim of this study is to document kinesiotape technique to support sucking and swallowing muscles for treating nutritional problems and for reducing nutrition risks and accelerating maturation. According to power of analysis of this study, 74 infants planned to assign to kinesiotaping group or control group randomly. In kinesiotaping group, infants feeding performance will be evaluated by measuring the amount of milk invested, maximum heart rate, oxygen saturation, speed of milk intake and counting the number of swallow during feeding. Kinesiotape will be applied to masseter and hyoid muscles 24 hours later after the birth of the infant. Infants will be evaluated before kinesiotape application, 3 hour later and 24 hour later after the application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kinesiotape | Experimental | Device: KinesiotapingKinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing. |
| Control | No intervention | –In this group the late preterm infants won't be applied kinesiotaping to suck and swallow muscles. |
Who may qualify
- Ages
- 1 month to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born in Baskent University Ankara Hospital,
- age between 34-36.6 weeks
Key exclusion criteria (8 listed)
- Infants with multiple kongenital anomaly,
- hypoxic ischemic encephalopathy,
- intraventricular and intracranial hemorrhage,
- necrotizing enterocolitis,
- tracheoesophageal fistula,
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 |
|---|---|---|
| KinesiotapingKinesiotape application to masseter and hyoid muscles of late preterm infants for improving sucking and swallowing. | Device | kinesiotape |
Primary outcome
the number of swallows of the baby during feeding
Time frame: Through study completion, an average of 1 year
digital stethoscope
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 17 Jan 2024.
- Individual participant dataSharing planned: No. If requested, then the investigators could share the IPD
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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.
Nilay Comuk Balci principal investigator
Ondokuz Mayıs 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 Kinesiotaping in people with Swallow and Preterm Infant, run by Ondokuz Mayıs 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 2 inclusion and 8 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 17 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?
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?
the number of swallows of the baby during feeding (time frame: Through study completion, an average of 1 year). 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 17 Jan 2024.