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

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

Study Overview

• Status: Completed
• Conditions: Non-nutritive Sucking
• Intervention / Treatment: Other: Weighted Pacifier; Other: Non-Weighted Pacifier

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Weighted Pacifier; Patient will receive a weighted pacifier for 48 hours of their stay in the NICU.	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.
PLACEBO_COMPARATOR: Non-Weighted Pacifier; Patient will receive a standard non-weighted pacifier for 48 hours of their stay in the NICU.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety determined by a Neonatal Infant Pain Scale (NIPS) score	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.	48 hours
efficiency determined by an Efficiency of Loss scale	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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress/ Discomfort determined by a Likert Scale	To determine if a stabilized pacifier reduces infant stress/discomfort	48 hours
Caregiver stress determined by a Likert Scale	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.	48 hours

Collaborators and Investigators

• Sponsor: Englewood Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 19, 2019
• Primary Completion (ACTUAL): November 18, 2021
• Study Completion (ACTUAL): November 18, 2021

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: E-19-782

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes