Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05036915
Study type Interventional
Source Acibadem University
Contact Zehra Kan Öntürk, Assist Prof
Phone 02165004163
Email [email protected]
Status Recruiting
Phase N/A
Start date May 2, 2021
Completion date May 1, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03169881 - Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants Phase 3
Recruiting NCT04523441 - Early Support and Physiotherapy for Children and Their Motor Skills
Completed NCT03272594 - The Influence of Breastfeeding on Cortical Activity During Procedures Phase 3
Recruiting NCT04545866 - The Budesonide in Babies (BiB) Trial Phase 3
Active, not recruiting NCT04354467 - Assessment of Urinary Neutrophil Gelatinase-Associated Lipocalin to Predict AKI in the NICU
Active, not recruiting NCT02545712 - Safe Excipient Exposure in Neonates and Small ChildreN N/A
Recruiting NCT04295564 - Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function Phase 2/Phase 3
Withdrawn NCT02764528 - Intervention Study to Improve Maternal Handwashing N/A
Completed NCT02379936 - Evaluation of Lactate Dehydrogenase as Decision Support for Admissions to Neonatal Ward N/A