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Feeding Maturity in Preterm Infants

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07273266
Enrollment
62
Registered
2025-12-09
Start date
2025-03-04
Completion date
2026-07-30
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding, Non Nutritive Sucking, Preterm

Keywords

preterm, feeding, non nutritive sucking, feeding maturation

Brief 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.

Interventions

DEVICERoutine 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.

DEVICERandom 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.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feeding maturityFrom 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.

Secondary

MeasureTime frameDescription
Change in Body WeightFrom initiation of total oral feeding to hospital discharge (average 5 weeks)Participant's body weight will be assessed at initiation of total oral feeding and at hospital discharge.
Length of Hospital StayFrom baseline to discharge (average 15 weeks)The time from date of hospitalization until the date of discharge.
Age at dischargeAt first discharge home, on average 37 weeks postmenstrual agePostmenstrual age (weeks) of the infant at the time of hospital discharge.

Countries

Turkey (Türkiye)

Contacts

Primary ContactZehra Kan Öntürk, Assoc.Prof.
zehrakan@gmail.com0265004163
Backup ContactZehra Kan Öntürk, Assoc.Prof.
zehrakan@gmail.com02165004163

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026