NCT07273266

Feeding Maturity in Preterm Infants

The Effect of Routine Versus Random Pacifier Administration Methods on Feeding Maturity in Preterm Infants

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Accepted

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. 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.

Conditions

• Preterm
• Feeding
• Non Nutritive Sucking

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-04
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2025-12-09
• Last updated: 2025-12-09

Locations

1 site across 1 country: Turkey (Türkiye)