Acıbadem University Atakent Hospital
Istanbul, Turkey (Türkiye)
NCT Number: NCT05036915
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.
Looking for future studies?
Notify Me1 day–28 day
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Preterm infants;
Exclusion criteria
Preterm infants;
Common Action Steps:
Action Steps of the Control Group:
Procedure Steps of the Experimental Group:
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
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
Time frame: From baseline to discharge (average 15 weeks)
The time from date of hospitalization until the date of discharge.
Acibadem University
Other
The Effect of Routine and Random Pacifier Use Methods in Preterm Infants on Transition to Bottle Feeding Process
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.
NCT07273266
Feeding, Female Urogenital Diseases and Pregnancy Complications
Istanbul, Ataşehir, Turkey (Türkiye)
View Trial DetailsNCT07045402
Comfort, Facilitated Tucking
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07122765
Blood Flow Velocity, Carbohydrate Metabolism
Washington D.C., District of Columbia, United States
View Trial DetailsNCT02919358
Body Weight, Body Weight Changes
Newark, Delaware, United States
View Trial Details