Weighted Pacifier Vs. Non-Weighted Pacifier

Englewood Hospital and Medical Center

Status

Completed

Conditions

Non-nutritive Sucking

Treatments

Other: Weighted Pacifier

Other: Non-Weighted Pacifier

Study type

Interventional

Funder types

Other

Identifiers

NCT04095702

E-19-782

Details and patient eligibility

About

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

Full 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.

Enrollment

45 patients

Sex

All

Ages

30 to 37 weeks old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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