Feeding Maturity in Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Routine NNS, Random NNS.
- Who it may be relevant to
- Registry conditions: Preterm, Feeding, Non Nutritive Sucking. Basic parameters: 0 Days — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Routine Versus Random Pacifier Administration Methods on Feeding Maturity in Preterm Infants
Overview
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.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- Preterm
- who are clinically stable, and
- who are within the first day of initiating enteral feeding.
Exclusion criteria
- Newborns who have a contraindication to pacifier use
- have comorbid medical conditions
- who are intubated
- have congenital anomalies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Acıbadem University — Istanbul
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. PMID 27699765
- 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. PMID 27754572
- 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. PMID 39920842
- 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. PMID 37203152
- 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. PMID 38626172
Identifiers
NCT: NCT07273266 · ATADEK-2024/19