Weighted Pacifier Vs. Non-Weighted Pacifier

Not Applicable

Completed

• Conditions: Non-nutritive Sucking
• Interventions: Other: Weighted Pacifier; Other: Non-Weighted Pacifier

• Registration Number: NCT04095702
• Lead Sponsor: Englewood Hospital and Medical Center

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.

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-09-17
• Study Start: 2019-09-19
• Study First Posted: 2019-09-19
• Primary Completion: 2021-11-18
• Study Completion: 2021-11-18
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weighted Pacifier	Weighted Pacifier	Patient will receive a weighted pacifier for 48 hours of their stay in the NICU.
Non-Weighted Pacifier	Non-Weighted Pacifier	Patient will receive a standard non-weighted pacifier for 48 hours of their stay in the NICU.

Primary Outcome Measures

Name	Time	Method
Safety determined by a Neonatal Infant Pain Scale (NIPS) score	48 hours	To determine if the weighted pacifier is safe in supporting non-nutritive suck. Neonates will be measured in facial expression, cry, breathing pattern, and state of arousal. Each category get a rating of 0 or 1, with 0 being negative and 1 being positive.
efficiency determined by an Efficiency of Loss scale	48 hours	To determine if the weighted pacifier is efficient in supporting non-nutritive suck. The neonates will be observed for a period of 10 minutes each time the pacifier is introduced. The observer will count the amount of time the neonate's pacifier pop from his/her mouth.

Secondary Outcome Measures

Name	Time	Method
Stress/ Discomfort determined by a Likert Scale	48 hours	To determine if a stabilized pacifier reduces infant stress/discomfort
Caregiver stress determined by a Likert Scale	48 hours	To determine if a caregiver's stress level decreases when an infant is provided with a stabilizing/weighted pacifier versus a traditional pacifier. The scale will consist of questions asking about the caregiver's stress. The caregiver will answer the questions with a 1-5 rating, with 1 being strongly disagree and 5 being strongly agree.

Trial Locations

Locations (1)

Englewood Health; 🇺🇸 Englewood, New Jersey, United States