Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2025-03-04
2026-07-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Routine NNS
Newborns who receive routine 5-minute pacifier use before each feeding will constitute the intervention group.
Routine NNS
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.
Control group (Random NNS)
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.
Random NNS
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.
Interventions
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Routine NNS
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 NNS
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.
Eligibility Criteria
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Inclusion Criteria
* who are clinically stable, and
* who are within the first day of initiating enteral feeding.
Exclusion Criteria
* have comorbid medical conditions
* who are intubated
* have congenital anomalies
0 Days
28 Days
ALL
Yes
Sponsors
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Acibadem University
OTHER
Responsible Party
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Zehra Kan Onturk
Assoc. Prof.
Principal Investigators
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Serdar Beken
Role: PRINCIPAL_INVESTIGATOR
Acibadem University
Locations
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Acıbadem University
Istanbul, Ataşehir, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Kaya 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.
Ecevit 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.
Munoz-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.
Zhao 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.
Other Identifiers
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ATADEK-2024/19
Identifier Type: -
Identifier Source: org_study_id
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