Skip to main content
OpenTrials
Completed

NCT Number: NCT05036915

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acıbadem University Atakent Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pacifier randomly

Procedure

Common Action Steps:

  • Legal representatives of newborns are informed about the study purpose, participants read and sign the informed consent form so their consent is obtained.
  • Inclusion and exclusion criteria are evaluated.
  • Study group is determined in line with the randomization order of the newborn to be included in the study.
  • First part of the patient information and follow-up form is completed.
  • Feeding content, amount and method are determined by the physician.

Action Steps of the Control Group:

  • Pacifier is randomly given to the infant for 30 min independent from feeding during the day.
  • Common procedure steps are applied.
  • Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method.
  • Second part of the patient information and follow-up form is completed daily.

Pacifier other

Procedure

Procedure Steps of the Experimental Group:

  • 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.
  • Common procedure steps are applied.
  • Pacifier is given for 5 min before each feeding.
  • Procedure steps are applied in accordance with the "Neonatal Nursing Protocols" according to the newborn's feeding method.
  • Second part of the patient information and follow-up form is completed daily.

Primary outcomes

  1. Change in feed intake

    Time frame: From baseline to transition to total oral feeding (average 15 weeks)

    Change in feed intake will be assessed from baseline to transition to total oral feeding

  2. Change in body weight

    Time frame: From baseline to transition to total oral feeding (average15 weeks)

    Participant's body weight will be assessed from baseline to transition to total oral feeding up to through study completion

  3. Length of hospital stay

    Time frame: From baseline to discharge (average 15 weeks)

    The time from date of hospitalization until the date of discharge.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

The Effect of Routine and Random Pacifier Use Methods in Preterm Infants on Transition to Bottle Feeding Process

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2021
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.