Premature InfantNCT06371443
Suction and Swalloing Exercises for Premature Babies
A study testing Sucking and swallowing exercises in people with Premature Infant, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported. This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants. Read more about this study
- Who is it for?
- Ages 34 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infant
- What is being tested?
- Sucking and swallowing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2021to 1 Aug 2022
- 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 34 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature babies with an updated gestational week of 34 weeks
- Premature babies born at 34-37 weeks of gestation
- Premature babies with stable vital signs
- Premature babies with underdeveloped sucking activity
Who cannot join
- intubated babies
- Babies with multiple anomalies
- Babies with asphyxia
- Infants with unstable vital signs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Sucking and Swallowing Exercises on the Transition Process to Oral Feeding in Premature İnfants
Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported.
This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants.
The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul. The study sample consisted of 82 premature infants. Of these infants, 41 were assigned to the experimental group and 41 to the control group. Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool. Throughout the study, preterm infants in the experimental group (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days. SPSS21 was used to analyze the data.
Read the detailed description
This study was conducted as a randomized controlled experimental study to evaluate the effect of sucking and swallowing training on the transition to oral feeding in premature infants. The study sought to answer the question, "Do suckling and swallowing exercises have an effect on the transition to oral feeding?". The study was carried out between December 2021 and June 2022 at the neonatal intensive care unit of a public hospital in Istanbul. The study sample consisted of infants who were admitted to the neonatal intensive care unit of a public hospital in Istanbul, who met the inclusion criteria, and whose parents consented to the study. A power analysis was performed to determine the number of subjects to be included in the study. The power of the test was calculated using the G*Power 3.1 program. Infants enrolled in the study were randomized in order of arrival to avoid bias. The randomization table was generated by "https://www.calculatorsoup.com" as follows.
Data were collected using the Premature Infant Data Collection Form and the Early Feeding Skills Assessment Tool.
The premature infant data collection form developed by the investigators consists of 2 parts. The first part contains descriptive information about the parents (gender, age, education level, number of children, social security). The second part contains descriptive details of the infant (sex, mode of delivery, Apgar score, week of birth, postmenstrual week at enrollment, birth weight, weight at enrollment, head circumference-height at birth, phototherapy status within the last 24 hours, oxygen support status).
Application in the experimental group: Informed consent was obtained from the parents of the infants in the experimental group who had low suckling success and met the inclusion criteria. After completing the premature infant data collection form, the investigator assessed the infant's sucking activity. Infants with no suck reflex were included in the study group. The oral motor stimulation exercises developed by Fucile and applied to the infants in the experimental group who needed suckling and swallowing exercises were evaluated according to the Early Feeding Skills measurement tool. The investigator performed the exercises on the infants once a day for 12 minutes before feeding for 14 days. After 14 days, the infants were assessed again using the EFS scale.
Application in the control group: First, informed consent was obtained from the parents of the infants in the control group who met the inclusion criteria. After completing the premature infant data collection form, the infant's sucking activity was assessed. Infants who did not show a suck reflex were included in the study group, and the infants were evaluated using the Early Feeding Skills (EFS) measurement tool at baseline and at 14 days.
The data collected in the study were analyzed using SPSS (Statistical Package for Social Sciences) 22.0 for Windows software. Numbers, percentages, means, and standard deviations were used as descriptive statistical methods to analyze the data. Kurtosis and skewness values were examined using chi-square and t-tests to determine whether the study variables were normally distributed.
The study was conducted after obtaining the necessary permissions from XXXXXXXX Non-Interventional Clinical Research Ethics Committee (decision number: 1054, date: 26.10.2021) and the hospital where the study was to be conducted, as well as the informed consent of the parents who consented their children to participate in the study. Infants enrolled in the study were not exposed to practices or procedures that would violate patient rights, that parents would consider inappropriate, or that would adversely affect the patient.
- Conditions
- Premature Infant
- Being tested
- Sucking and swallowing exercises
- Keywords
- Oral feeding, sucking-swallowing exercises, premature Infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucking and swallowing exercisesBehavioural
Sucking-swallowing exercises were applied to premature infants in the experimental group (n=41) for 14 days, once a day, 12 minutes before feeding.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 41 premature infants in the experimental group Receives: Behavioral: Sucking and swallowing exercises |
| control group | No intervention | 41 premature infants in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The early feeding skills assessment tool (EFS)
This scale is a reliable tool that assesses skills that contribute to safe and successful oral feeding of preterm infants in 5 sub-dimensions. Sub-dimensions include respiratory regulation, oral motor function, swallowing coordination, feeding participation, and physiological stability.
Measured: December 2021 and June 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start3 Dec 2021
- Primary completion1 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies 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
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysel kokcudogan, Istanbul Medipol University Hospital
- Investigators
- Elif Arslan, Principal investigator, Medipol UniversityAysel Kokcu Dogan, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371443
- Sponsor's protocol ID
- ayselkokcudogan
- Status last verified
- Jul 2024
- First submitted
- 19 Aug 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gokdemir E, Dogan AK. The Effect of Suckling and Swallowing Exercises During the Transition to Oral Feeding in Premature Infants: Randomized Controlled Study. Niger J Clin Pract. 2025 Jun 1;28(6):708-715. doi: 10.4103/njcp.njcp_41_25. Epub 2025 Jun 25.
PubMed 40556083
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sucking and Swallowing Exercises on the Transition Process to Oral Feeding in Premature İnfants
- ClinicalTrials.gov ID
- NCT06371443
- Acronym / sponsor ID
- ayselkokcudogan
- Conditions
- Premature Infant
- Keywords
- Oral feeding, sucking-swallowing exercises, premature Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 17 Apr 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.
Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported.
This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants.
The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul. The study sample consisted of 82 premature infants. Of these infants, 41 were assigned to the experimental group and 41 to the control group. Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool. Throughout the study, preterm infants in the experimental group (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days. SPSS21 was used to analyze the data.
Detailed description
This study was conducted as a randomized controlled experimental study to evaluate the effect of sucking and swallowing training on the transition to oral feeding in premature infants. The study sought to answer the question, "Do suckling and swallowing exercises have an effect on the transition to oral feeding?". The study was carried out between December 2021 and June 2022 at the neonatal intensive care unit of a public hospital in Istanbul. The study sample consisted of infants who were admitted to the neonatal intensive care unit of a public hospital in Istanbul, who met the inclusion criteria, and whose parents consented to the study. A power analysis was performed to determine the number of subjects to be included in the study. The power of the test was calculated using the G*Power 3.1 program. Infants enrolled in the study were randomized in order of arrival to avoid bias. The randomization table was generated by "https://www.calculatorsoup.com" as follows.
Data were collected using the Premature Infant Data Collection Form and the Early Feeding Skills Assessment Tool.
The premature infant data collection form developed by the investigators consists of 2 parts. The first part contains descriptive information about the parents (gender, age, education level, number of children, social security). The second part contains descriptive details of the infant (sex, mode of delivery, Apgar score, week of birth, postmenstrual week at enrollment, birth weight, weight at enrollment, head circumference-height at birth, phototherapy status within the last 24 hours, oxygen support status).
Application in the experimental group: Informed consent was obtained from the parents of the infants in the experimental group who had low suckling success and met the inclusion criteria. After completing the premature infant data collection form, the investigator assessed the infant's sucking activity. Infants with no suck reflex were included in the study group. The oral motor stimulation exercises developed by Fucile and applied to the infants in the experimental group who needed suckling and swallowing exercises were evaluated according to the Early Feeding Skills measurement tool. The investigator performed the exercises on the infants once a day for 12 minutes before feeding for 14 days. After 14 days, the infants were assessed again using the EFS scale.
Application in the control group: First, informed consent was obtained from the parents of the infants in the control group who met the inclusion criteria. After completing the premature infant data collection form, the infant's sucking activity was assessed. Infants who did not show a suck reflex were included in the study group, and the infants were evaluated using the Early Feeding Skills (EFS) measurement tool at baseline and at 14 days.
The data collected in the study were analyzed using SPSS (Statistical Package for Social Sciences) 22.0 for Windows software. Numbers, percentages, means, and standard deviations were used as descriptive statistical methods to analyze the data. Kurtosis and skewness values were examined using chi-square and t-tests to determine whether the study variables were normally distributed.
The study was conducted after obtaining the necessary permissions from XXXXXXXX Non-Interventional Clinical Research Ethics Committee (decision number: 1054, date: 26.10.2021) and the hospital where the study was to be conducted, as well as the informed consent of the parents who consented their children to participate in the study. Infants enrolled in the study were not exposed to practices or procedures that would violate patient rights, that parents would consider inappropriate, or that would adversely affect the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Sucking and swallowing exercises41 premature infants in the experimental group |
| control group | No intervention | –41 premature infants in the control group |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Premature babies with an updated gestational week of 34 weeks
- Premature babies born at 34-37 weeks of gestation
- Premature babies with stable vital signs
- Premature babies with underdeveloped sucking activity
Key exclusion criteria (4 listed)
- intubated babies
- Babies with multiple anomalies
- Babies with asphyxia
- Infants with unstable vital signs
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 |
|---|---|---|
| Sucking and swallowing exercisesSucking-swallowing exercises were applied to premature infants in the experimental group (n=41) for 14 days, once a day, 12 minutes before feeding. | Behavioural | experimental group |
Primary outcome
The early feeding skills assessment tool (EFS)
Time frame: December 2021 and June 2022
This scale is a reliable tool that assesses skills that contribute to safe and successful oral feeding of preterm infants in 5 sub-dimensions. Sub-dimensions include respiratory regulation, oral motor function, swallowing coordination, feeding participation, and physiological stability.
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 3 Jul 2024.
- Derived from this study: PubMed 40556083Gokdemir E, Dogan AK. The Effect of Suckling and Swallowing Exercises During the Transition to Oral Feeding in Premature Infants: Randomized Controlled Study. Niger J Clin Pract. 2025 Jun 1;28(6):708-715. doi: 10.4103/njcp.njcp_41_25. Epub 2025 Jun 25.
- 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.
Elif Arslan principal investigator
Medipol University
Aysel Kokcu Dogan study director
Medipol 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 Sucking and swallowing exercises in people with Premature Infant, run by Istanbul Medipol University Hospital 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 4 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 3 Jul 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 early feeding skills assessment tool (EFS) (time frame: December 2021 and June 2022). 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 NCT06371443, which also lists 1 linked publication.
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 3 Jul 2024.