The Effect of Routine and Random Pacifier Use Methods in Preterm Infants

Acibadem University

Status: Completed

Conditions: Neonatal; Feeding

Treatments: Procedure: Pacifier other; Procedure: Pacifier randomly

Study type: Interventional

Funder types: Other

Identifiers

NCT05036915

ATADEK-2021/08

Details and patient eligibility

About

The aim of this study is to determine the effect of the routine 5-min pacifier use before feeding and the random 30-min pacifier use independent from feeding during the day on the transition to bottle feeding process in preterm infants.

Full description

Preterm infants, may most frequently experience feeding difficulties as a result of lower oral-motor tone, poor coordination during sucking-swallowing-respiration, sleepy behavior, gastrointestinal dysmotility and immature sucking pressure and being unable to sustain their physiological values at a normal level during feeding. In the literature, it is reported that approximately 82% of preterm infants have an oral feeding difficulty. As a consequence, it is a very complex process to acquire a safe and effective feeding skill and preterm infants need support in the weeks after birth until participants develop skills that are necessary for oral feeding and complete a successful transition to total oral feeding independent from orogastric catheter.

Although studies have stressed positive effects of the Non-nutritive sucking (NNS) intervention on feeding performance, it is reported that there is a need for more comprehensive randomized controlled studies revealing the use frequency, duration or effect of time.

In the Neonatal Intensive Care Unit (NICU) where the study will be conducted, an appropriate method is chosen for preterm infants based on their general condition and the feeding transition stages are determined incrementally with repetitive follow-ups during feeding. The routine 5-min pacifier use method before feeding and the random 30-min pacifier use method during the day will be applied to newborns who have enteral feeding. Newborns who already use pacifier independent from feeding during the day in the clinic and to whom these methods are applied, will comprise the control group. In order to ensure a homogeneous application in the control group, the pacifier use duration will be limited to 30 minutes. Pacifier use durations have been determined in line with the literature examining the contribution of pacifier use to the feeding of preterm infants. Newborns, to whom the routine 5-min pacifier use method is applied before each feeding, will comprise the experimental group. All newborns included in the study will be followed until participants are discharged.

Enrollment: 43 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

Preterm infants;

• Whose legal representatives agree to take part in the study and sign the informed consent form,
• Who have a stable clinical picture,
• Who are on the first day of enteral feeding will be included in the study.

Exclusion criteria

Preterm infants;

• Who have a comorbidity,
• Who are intubated,
• Who have an inherent anomaly,
• Who have parenteral feeding will not be included in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Control group (Pacifier randomly 30 min)

Experimental group

Description:

Pacifier is randomly given to the infant for 30 min independent from feeding during the day

Treatment:

Procedure: Pacifier randomly

Experimental Group (Pacifier randomly 30 min+ routine 5 min before each feeding)

Experimental group

Description:

Pacifier is randomly given to the infant for 30 min independent from feeding during the day. In addition, pacifier is given to the infant for 5 min before each feeding.

Treatment:

Procedure: Pacifier other