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Weighted Pacifier Vs. Non-Weighted Pacifier

Primary Purpose

Non-nutritive Sucking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weighted Pacifier
Non-Weighted Pacifier
Sponsored by
Englewood Hospital and Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-nutritive Sucking

Eligibility Criteria

30 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Englewood Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Weighted Pacifier

Non-Weighted Pacifier

Arm Description

Patient will receive a weighted pacifier for 48 hours of their stay in the NICU.

Patient will receive a standard non-weighted pacifier for 48 hours of their stay in the NICU.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Stress/ Discomfort determined by a Likert Scale
To determine if a stabilized pacifier reduces infant stress/discomfort
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.

Full Information

First Posted
August 22, 2019
Last Updated
July 25, 2022
Sponsor
Englewood Hospital and Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04095702
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
November 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Englewood Hospital and Medical Center

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-nutritive Sucking

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weighted Pacifier
Arm Type
Experimental
Arm Description
Patient will receive a weighted pacifier for 48 hours of their stay in the NICU.
Arm Title
Non-Weighted Pacifier
Arm Type
Placebo Comparator
Arm Description
Patient will receive a standard non-weighted pacifier for 48 hours of their stay in the NICU.
Intervention Type
Other
Intervention Name(s)
Weighted Pacifier
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-Weighted Pacifier
Intervention Description
The non-weighted pacifier is a standard of care pacifier that a neonate would receive if they were not part of this study.
Primary Outcome Measure Information:
Title
Safety determined by a Neonatal Infant Pain Scale (NIPS) score
Description
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.
Time Frame
48 hours
Title
efficiency determined by an Efficiency of Loss scale
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Stress/ Discomfort determined by a Likert Scale
Description
To determine if a stabilized pacifier reduces infant stress/discomfort
Time Frame
48 hours
Title
Caregiver stress determined by a Likert Scale
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States

12. IPD Sharing Statement

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Weighted Pacifier Vs. Non-Weighted Pacifier

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