PrematureNCT05530733
Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding: Randomized Controlled Trial
A study testing Pacifier and Breast milk in people with Premature and Pacifiers, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study was to assess how preterm babies' vital signs, feeding time, and gastric residual volume were affected by using a pacifier only or a pacifier with breast milk during orogastric tube feeding. Read more about this study
- Who is it for?
- Ages 29 to 34 weeks
- Conditions the study is for
- Premature, Pacifiers, Tube Feeding
- What is being tested?
- Pacifier and Breast milk
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 15 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 29 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Feeding with the orogastric tube
- Breastmilk along with formula (babies who receive more than 50% of their total feed in 24 hours from formula)
- Gestation week between 29+0 weeks and 34+0 weeks
- Weight of 1000 g or more
Who cannot join
- Receiving mechanical ventilator support
- Development of sepsis
- Presence of neurological disease
- Presence of chromosomal or congenital anomalies
- Presence of intraventricular bleeding
- Unstable physiological parameters
- No breast milk
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study was to assess how preterm babies' vital signs, feeding time, and gastric residual volume were affected by using a pacifier only or a pacifier with breast milk during orogastric tube feeding.
- Conditions
- Premature, Pacifiers, Tube Feeding, Neonatal Nursing
- Being tested
- Pacifier, Breast milk
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacifierProcedure or surgery
Pacifiers produced for premature babies will be used in the study. Pacifiers will be made of silicone material suitable for premature baby health and will not contain any harmful substances. A separate pacifier will be used for each baby, and pacifiers will be sterilized before use.
Breast milkProcedure or surgery
For babies assigned to the pacifier with breast milk group, their own breast milk will be applied by dripping 1 ml into the pacifier.
| Study group | Role | What they receive |
|---|---|---|
| Pacifier only | Other | Participants in the pacifier-only group will get a pacifier five minutes prior to tube feeding. During feedings, a pacifier will be employed. Five minutes following the end of tube feeding, the pacifier application will be discontinued. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the volume of gastric residue will be controlled. Receives: Procedure: Pacifier |
| Pacifier with breast milk | Other | Five minutes prior to tube feeding, participants in the pacifier with breast milk group will get their own breast milk dripping pacifier. During feedings, a pacifier will be employed. Five minutes following the end of tube feeding, the pacifier application will be discontinued. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the amount of gastric residue will be controlled. Receives: Procedure: Pacifier; Procedure: Breast milk |
| standard care (no pacifier) | No intervention | The premature babies in the standard care (no pacifier) will get standard care while being fed through an orogastric tube. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the amount of gastric residue will be controlled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate change
Heart rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Measured: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
Respiratory rate change
Respiratory rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Measured: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
Saturation level change
Saturation level will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Measured: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
Feeding duration
Each baby's tube feeding duration will be measured.
Measured: measured with a stopwatch for 7 months.
Gastric residual volume
Gastric residue will be measured 2 hours after the end of infant feeding.
Measured: Gastric residue will be measured 2 hours after the end of infant feeding.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jun 2022
- Primary completion1 Feb 2024
- Study completion15 Feb 2024
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 PrematureStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Taşdelen, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530733
- Sponsor's protocol ID
- BEU-YTASDELEN-001
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Topan A, Kurtuncu M, Ekmen S, Tasdelen Y, Yigit D, Ilgaz K. Pacifier use in preterm infants during orogastric tube feeding: a randomized trial. Rev Assoc Med Bras (1992). 2026 Jul 10;72(5):e20252089. doi: 10.1590/1806-9282.20252089. eCollection 2026.
PubMed 42454843
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05530733
- Acronym / sponsor ID
- BEU-YTASDELEN-001
- Conditions
- Premature, Pacifiers, Tube Feeding, Neonatal Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 7 Sep 2022 (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.
The purpose of the study was to assess how preterm babies' vital signs, feeding time, and gastric residual volume were affected by using a pacifier only or a pacifier with breast milk during orogastric tube feeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pacifier only | Other | Procedure: PacifierParticipants in the pacifier-only group will get a pacifier five minutes prior to tube feeding. During feedings, a pacifier will be employed. Five minutes following the end of tube feeding, the pacifier application will be discontinued. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the volume of gastric residue will be controlled. |
| Pacifier with breast milk | Other | Procedure: Pacifier, Procedure: Breast milkFive minutes prior to tube feeding, participants in the pacifier with breast milk group will get their own breast milk dripping pacifier. During feedings, a pacifier will be employed. Five minutes following the end of tube feeding, the pacifier application will be discontinued. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the amount of gastric residue will be controlled. |
| standard care (no pacifier) | No intervention | –The premature babies in the standard care (no pacifier) will get standard care while being fed through an orogastric tube. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the amount of gastric residue will be controlled. |
Who may qualify
- Ages
- 29 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Feeding with the orogastric tube
- Breastmilk along with formula (babies who receive more than 50% of their total feed in 24 hours from formula)
- Gestation week between 29+0 weeks and 34+0 weeks
- Weight of 1000 g or more
Key exclusion criteria (7 listed)
- Receiving mechanical ventilator support
- Development of sepsis
- Presence of neurological disease
- Presence of chromosomal or congenital anomalies
- Presence of intraventricular bleeding
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 |
|---|---|---|
| PacifierPacifiers produced for premature babies will be used in the study. Pacifiers will be made of silicone material suitable for premature baby health and will not contain any harmful substances. A separate pacifier will be used for each baby, and pacifiers will be sterilized before use. | Procedure or surgery | Pacifier only, Pacifier with breast milk |
| Breast milkFor babies assigned to the pacifier with breast milk group, their own breast milk will be applied by dripping 1 ml into the pacifier. | Procedure or surgery | Pacifier with breast milk |
Primary outcome
Heart rate change
Time frame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
Heart rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Respiratory rate change
Time frame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
Respiratory rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Saturation level change
Time frame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding
Saturation level will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.
Feeding duration
Time frame: measured with a stopwatch for 7 months.
Each baby's tube feeding duration will be measured.
Gastric residual volume
Time frame: Gastric residue will be measured 2 hours after the end of infant feeding.
Gastric residue will be measured 2 hours after the end of infant feeding.
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 16 Oct 2024.
- Derived from this study: PubMed 42454843Topan A, Kurtuncu M, Ekmen S, Tasdelen Y, Yigit D, Ilgaz K. Pacifier use in preterm infants during orogastric tube feeding: a randomized trial. Rev Assoc Med Bras (1992). 2026 Jul 10;72(5):e20252089. doi: 10.1590/1806-9282.20252089. eCollection 2026.
- 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.
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 Pacifier and Breast milk in people with Premature and Pacifiers, run by Zonguldak Bulent Ecevit 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 16 Oct 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?
Heart rate change (time frame: 5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding). The study lists 5 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 NCT05530733, 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 16 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.