PretermNCT07273266
Feeding Maturity in Preterm Infants
A study testing Routine NNS and Random NNS in people with Preterm and Feeding, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of two pacifier-use strategies-routine 5-minute pacifier use prior to each feeding versus random 30-minute pacifier use at any time of day, independent of feeding-on feeding maturity in preterm infants. Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm, Feeding, Non Nutritive Sucking
- What is being tested?
- Routine NNS and Random NNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm
- who are clinically stable, and
- who are within the first day of initiating enteral feeding.
Who cannot join
- Newborns who have a contraindication to pacifier use
- have comorbid medical conditions
- who are intubated
- have congenital anomalies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acıbadem University
Istanbul, Ataşehir, 34750
Zehra Kan Öntürk, Assoc. Prof., 02165004163, zehrakan@gmail.com
Serdar Beken, Prof., 02165004023, serdar.beken@aciadem.com
About this study
Official title: The Effect of Routine Versus Random Pacifier Administration Methods on Feeding Maturity in Preterm Infants
The aim of this study is to evaluate the effect of two pacifier-use strategies-routine 5-minute pacifier use prior to each feeding versus random 30-minute pacifier use at any time of day, independent of feeding-on feeding maturity in preterm infants. The hypotheses of the study are as follows: H1: The routine use of a pacifier prior to feeding has a positive effect on feeding maturity in preterm infants.
H2: The routine use of a pacifier prior to feeding has a positive effect on discharge weight in preterm infants.
Read more
H3: The routine use of a pacifier prior to feeding has a positive effect on the length of hospital stay in preterm infants.
H4: The routine use of a pacifier prior to feeding has a positive effect on the gestational age at discharge in preterm infants.
Read the detailed description
Developing safe and effective feeding skills in preterm infants is a highly complex process. To achieve feeding maturity, preterm infants must establish oropharyngeal anatomical integrity, adequate neurological function, and full coordination of sucking, swallowing, and breathing. Due to this immaturity, they frequently experience oral feeding difficulties such as low oral-motor tone, poor suck-swallow-breath coordination, sleepiness, gastrointestinal dysmotility, immature sucking pressure, and an inability to maintain stable physiological parameters during feeding. Effective oral feeding is crucial for optimal growth, safe discharge, and the prevention of aspiration and long-term respiratory or neurological complications.
For this reason, preterm infants require support until they develop the necessary skills for oral feeding and successfully transition from orogastric tube feeding to total oral intake. During this transition period, early oral stimulation methods help promote oral development and self-regulation. Among these supportive and complementary strategies, non-nutritive sucking (NNS) facilitates the progression toward oral feeding. Evidence indicates that infants who receive NNS transition to full oral feeding more quickly, demonstrate better feeding performance, achieve more organized sucking behavior, experience improved digestion, and remain more active during feeds.
Although studies emphasize the benefits of NNS, research examining how the frequency, duration, or timing of NNS influences feeding maturity remains limited.
- Conditions
- Preterm, Feeding, Non Nutritive Sucking
- Being tested
- Routine NNS, Random NNS
- Keywords
- preterm, feeding, non nutritive sucking, feeding maturation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine NNSDevice
The content, volume, and method of feeding are determined by the physician. A pacifier is provided for 5 minutes before each feeding. Procedures are carried out in accordance with the "Newborn Nursing Protocols," based on the infant's feeding method.
Feeding maturity is assessed once a week using a feeding monitor.
Random NNSDevice
The content, volume, and method of feeding are determined by the physician. The infant is given a pacifier for 30 minutes at random times during the day, independent of feeding.
Procedures are carried out in accordance with the "Newborn Nursing Protocols," based on the infant's feeding method.
Feeding maturity is assessed once a week using a feeding monitor.
| Study group | Role | What they receive |
|---|---|---|
| Routine NNS | Experimental | Newborns who receive routine 5-minute pacifier use before each feeding will constitute the intervention group. Receives: Device: Routine NNS |
| Control group (Random NNS) | Other | Newborns who are given a pacifier for 30 minutes at random times throughout the day, independent of feeding and based on the infant's cues, will constitute the control group. Receives: Device: Random NNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding maturity
Feeding maturity will be evaluated using a feeding monitor, assessing key swallowing and respiratory coordination parameters, including the number and duration of rhythmic swallows, rest periods, swallow-respiration patterns, and total milk volume consumed.
Measured: From the start of oral feeding until hospital discharge; assessed weekly for up to 6 weeks. The change in these time intervals will be assessed.
Secondary outcomes (3)
Change in Body Weight
Participant's body weight will be assessed at initiation of total oral feeding and at hospital discharge.
Measured: From initiation of total oral feeding to hospital discharge (average 5 weeks)
Length of Hospital Stay
The time from date of hospitalization until the date of discharge.
Measured: From baseline to discharge (average 15 weeks)
Age at discharge
Postmenstrual age (weeks) of the infant at the time of hospital discharge.
Measured: At first discharge home, on average 37 weeks postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start4 Mar 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (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 PretermStudies 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
- Investigators
- Serdar Beken, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273266
- Sponsor's protocol ID
- ATADEK-2024/19
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.
PubMed 27699765Kaya V, Aytekin A. Effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants: a randomised controlled trial. J Clin Nurs. 2017 Jul;26(13-14):2055-2063. doi: 10.1111/jocn.13617. Epub 2017 Mar 21.
PubMed 27754572Ecevit A, Erdogan B, Anuk Ince D, Aksu M, Unal S, Turan O, Saracoglu A, Tarcan A. Determination of oral feeding skills in late preterm, early term, and full-term infants using the neonatal oral feeding monitor (NeoSAFE). Ital J Pediatr. 2025 Feb 7;51(1):38. doi: 10.1186/s13052-025-01867-2.
PubMed 39920842Munoz-Gomez E, Ingles M, Molla-Casanova S, Sempere-Rubio N, Serra-Ano P, Aguilar-Rodriguez M. Effects of an Oral Stimulation Program on Feeding Outcomes in Preterm Infants: A Systematic Review and Meta-Analysis. Phys Occup Ther Pediatr. 2024;44(1):110-127. doi: 10.1080/01942638.2023.2212767. Epub 2023 May 18.
PubMed 37203152Zhao S, Jiang H, Miao Y, Liu W, Li Y, Zhang Y, Wang A, Cui X. Effects of implementing non-nutritive sucking on oral feeding progression and outcomes in preterm infants: A systematic review and meta-analysis. PLoS One. 2024 Apr 16;19(4):e0302267. doi: 10.1371/journal.pone.0302267. eCollection 2024.
PubMed 38626172
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Routine Versus Random Pacifier Administration Methods on Feeding Maturity in Preterm Infants
- ClinicalTrials.gov ID
- NCT07273266
- Acronym / sponsor ID
- ATADEK-2024/19
- Conditions
- Preterm, Feeding, Non Nutritive Sucking
- Keywords
- preterm, feeding, non nutritive sucking, feeding maturation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 9 Dec 2025 (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 aim of this study is to evaluate the effect of two pacifier-use strategies-routine 5-minute pacifier use prior to each feeding versus random 30-minute pacifier use at any time of day, independent of feeding-on feeding maturity in preterm infants. The hypotheses of the study are as follows: H1: The routine use of a pacifier prior to feeding has a positive effect on feeding maturity in preterm infants.
H2: The routine use of a pacifier prior to feeding has a positive effect on discharge weight in preterm infants.
H3: The routine use of a pacifier prior to feeding has a positive effect on the length of hospital stay in preterm infants.
H4: The routine use of a pacifier prior to feeding has a positive effect on the gestational age at discharge in preterm infants.
Detailed description
Developing safe and effective feeding skills in preterm infants is a highly complex process. To achieve feeding maturity, preterm infants must establish oropharyngeal anatomical integrity, adequate neurological function, and full coordination of sucking, swallowing, and breathing. Due to this immaturity, they frequently experience oral feeding difficulties such as low oral-motor tone, poor suck-swallow-breath coordination, sleepiness, gastrointestinal dysmotility, immature sucking pressure, and an inability to maintain stable physiological parameters during feeding. Effective oral feeding is crucial for optimal growth, safe discharge, and the prevention of aspiration and long-term respiratory or neurological complications.
For this reason, preterm infants require support until they develop the necessary skills for oral feeding and successfully transition from orogastric tube feeding to total oral intake. During this transition period, early oral stimulation methods help promote oral development and self-regulation. Among these supportive and complementary strategies, non-nutritive sucking (NNS) facilitates the progression toward oral feeding. Evidence indicates that infants who receive NNS transition to full oral feeding more quickly, demonstrate better feeding performance, achieve more organized sucking behavior, experience improved digestion, and remain more active during feeds.
Although studies emphasize the benefits of NNS, research examining how the frequency, duration, or timing of NNS influences feeding maturity remains limited.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine NNS | Experimental | Device: Routine NNSNewborns who receive routine 5-minute pacifier use before each feeding will constitute the intervention group. |
| Control group (Random NNS) | Other | Device: Random NNSNewborns who are given a pacifier for 30 minutes at random times throughout the day, independent of feeding and based on the infant's cues, will constitute the control group. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm
- who are clinically stable, and
- who are within the first day of initiating enteral feeding.
Key exclusion criteria (4 listed)
- Newborns who have a contraindication to pacifier use
- have comorbid medical conditions
- who are intubated
- have congenital anomalies
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 |
|---|---|---|
| Routine NNSThe content, volume, and method of feeding are determined by the physician. A pacifier is provided for 5 minutes before each feeding. Procedures are carried out in accordance with the "Newborn Nursing Protocols," based on the infant's feeding method. Feeding maturity is assessed once a week using a feeding monitor. | Device | Routine NNS |
| Random NNSThe content, volume, and method of feeding are determined by the physician. The infant is given a pacifier for 30 minutes at random times during the day, independent of feeding. Procedures are carried out in accordance with the "Newborn Nursing Protocols," based on the infant's feeding method. Feeding maturity is assessed once a week using a feeding monitor. | Device | Control group (Random NNS) |
Primary outcome
Feeding maturity
Time frame: From the start of oral feeding until hospital discharge; assessed weekly for up to 6 weeks. The change in these time intervals will be assessed.
Feeding maturity will be evaluated using a feeding monitor, assessing key swallowing and respiratory coordination parameters, including the number and duration of rhythmic swallows, rest periods, swallow-respiration patterns, and total milk volume consumed.
3 secondary outcomes
Change in Body Weight
Time frame: From initiation of total oral feeding to hospital discharge (average 5 weeks)
Length of Hospital Stay
Time frame: From baseline to discharge (average 15 weeks)
Age at discharge
Time frame: At first discharge home, on average 37 weeks postmenstrual age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 27699765Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.
- Background: PubMed 27754572Kaya V, Aytekin A. Effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants: a randomised controlled trial. J Clin Nurs. 2017 Jul;26(13-14):2055-2063. doi: 10.1111/jocn.13617. Epub 2017 Mar 21.
- Background: PubMed 39920842Ecevit A, Erdogan B, Anuk Ince D, Aksu M, Unal S, Turan O, Saracoglu A, Tarcan A. Determination of oral feeding skills in late preterm, early term, and full-term infants using the neonatal oral feeding monitor (NeoSAFE). Ital J Pediatr. 2025 Feb 7;51(1):38. doi: 10.1186/s13052-025-01867-2.
- Background: PubMed 37203152Munoz-Gomez E, Ingles M, Molla-Casanova S, Sempere-Rubio N, Serra-Ano P, Aguilar-Rodriguez M. Effects of an Oral Stimulation Program on Feeding Outcomes in Preterm Infants: A Systematic Review and Meta-Analysis. Phys Occup Ther Pediatr. 2024;44(1):110-127. doi: 10.1080/01942638.2023.2212767. Epub 2023 May 18.
- Background: PubMed 38626172Zhao S, Jiang H, Miao Y, Liu W, Li Y, Zhang Y, Wang A, Cui X. Effects of implementing non-nutritive sucking on oral feeding progression and outcomes in preterm infants: A systematic review and meta-analysis. PLoS One. 2024 Apr 16;19(4):e0302267. doi: 10.1371/journal.pone.0302267. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Preterm
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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.
Serdar Beken principal investigator
Acibadem 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 Routine NNS and Random NNS in people with Preterm and Feeding, run by Acibadem 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 3 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zehra Kan Öntürk, Assoc.Prof. (0265004163, zehrakan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding maturity (time frame: From the start of oral feeding until hospital discharge; assessed weekly for up to 6 weeks. The change in these time intervals will be assessed.). 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 NCT07273266, 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 9 Dec 2025.