Clinical trial NCT04095702: Weighted Pacifier Vs. Non-Weighted Pacifier
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-nutritive Sucking
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion

* 30 week-37.6 gestational age
* Patient is admitted to the NICU
* The patient has the ability to suck as noted in the patient's infant assessment flow sheet prior to enrollment

Exclusion

* Patient with an oral pharyngeal defect
* Patient with an oral feeding tube
* Patient with any medical reason that deems them unfit for the study as '''''''determined by the neonatologist
* Patient with sustained apnea during sucking

Primary outcomes:
measure: Safety determined by a Neonatal Infant Pain Scale (NIPS) score
timeFrame: 48 hours
measure: efficiency determined by an Efficiency of Loss scale
timeFrame: 48 hours
Secondary outcomes:
measure: Stress/ Discomfort determined by a Likert Scale
timeFrame: 48 hours
measure: Caregiver stress determined by a Likert Scale
timeFrame: 48 hours
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
Study officials:
References: