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Clinical Trial Summary

This study will determine if it is beneficial to use a weighted pacifier in neonates.


Clinical Trial Description

RCI-Pacifiers have been utilized for decades in the NICU to provide benifical Non-Nutritive Suck. They have been instrumental in transitioning premature infants from gavage to breast feeding Yiallouerou, S, et al, studied the effects of dummy/pacifier on autonomic activity during sleep and found pacifier use to be protective during sleep. Risks and Benefits of Pacifiers have cleary been identified Sexton, S and Natsale, R have identified that nonnutritive suck is a natural reflex for a fetus and newborn. Traditionally, the pacifier has been used as a method for fulfilling an infants innate desire to suckle. Study subjects will be introduced to either a standard/traditional pacifier (without stabilizing/weighted attachment) or a stabilizing/weighted pacifier. Standard/traditional pacifiers will be issued to patients that have been assigned an odd number study identifier and , stabilzing/weighted pacifiers will be issued to patients that have been assigned an even number study identifier. All eligible infants born at 30 weeks to 37.6 weeks who meet study criteria will be included. All staff/caregivers will be trained in proper placement of a stabilizing pacifier prior to use. Stabilizing pacifiers will not be placed on the infants chest. Traditional pacifiers will be used as standard of care at EH. The Neonatal Infant Pain Score (NIPS) scale and a caregiver survey will be used to determine efficacy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04095702
Study type Interventional
Source Englewood Hospital and Medical Center
Contact
Status Completed
Phase N/A
Start date September 19, 2019
Completion date November 18, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT06065839 - Effect of Non-nutritive Sucking on Feeding Intolerance N/A
Recruiting NCT03801785 - Efficacy of Non-Nutritive Sucking (NNS) on Balance and Gait Measured in 12-42 Month-Old Healthy Children Over 36 Months N/A