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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Medipol University

    Istanbul, Beykoz, 34810

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06371443
Study groupRoleWhat they receive
experimental groupExperimental41 premature infants in the experimental group
Receives: Behavioral: Sucking and swallowing exercises
control groupNo intervention41 premature infants in the control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted17 Apr 2024
  2. Study start3 Dec 2021
  3. Primary completion1 Jun 2022
  4. Study completion1 Aug 2022

Resources

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)
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

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.

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