NCT04095702

Weighted Pacifier Vs. Non-Weighted Pacifier

A Pilot Study to Look at the Use of Stabilizing (Weighted) Pacifier vs. the Use of a Traditional Non-Stabilizing (Non-Weighted) Pacifier to Improve Infant Comfort, Caregiver Satisfaction, and Safety During Non-Nutritive Sucking

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Englewood Hospital and Medical Center · Academic / Other
• Sex: All
• Age: 30 Weeks – 37 Weeks
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Non-nutritive Sucking

Interventions

Type	Name	Description
OTHER	Weighted Pacifier	The weighted pacifier is a standard of care pacifier with a weighted, breathable star attachment to help keep the pacifier from popping out of the neonates mouth during non-nutritive suck.
OTHER	Non-Weighted Pacifier	The non-weighted pacifier is a standard of care pacifier that a neonate would receive if they were not part of this study.

Timeline

• Start date: 2019-09-19
• Primary completion: 2021-11-18
• Completion: 2021-11-18
• First posted: 2019-09-19
• Last updated: 2022-07-26

Locations

1 site across 1 country: United States