Feeding Maturity in Preterm Infants

Acibadem University

Status: Enrolling

Conditions: Non Nutritive Sucking; Preterm; Feeding

Treatments: Device: Routine NNS; Device: Random NNS

Study type: Interventional

Funder types: Other

Identifiers

NCT07273266

ATADEK-2024/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Routine NNS

Experimental group

Description:

Newborns who receive routine 5-minute pacifier use before each feeding will constitute the intervention group.

Treatment:

Device: Routine NNS

Control group (Random NNS)

Other group

Description:

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.

Treatment:

Device: Random NNS