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
1 other identifier
interventional
45
1 country
1
Brief Summary
This study will determine if it is beneficial to use a weighted pacifier in neonates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
September 19, 2019
CompletedStudy Start
First participant enrolled
September 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2021
CompletedJuly 26, 2022
July 1, 2022
2.2 years
August 22, 2019
July 25, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Stress/ Discomfort determined by a Likert Scale
48 hours
Caregiver stress determined by a Likert Scale
48 hours
Study Arms (2)
Weighted Pacifier
EXPERIMENTALPatient will receive a weighted pacifier for 48 hours of their stay in the NICU.
Non-Weighted Pacifier
PLACEBO COMPARATORPatient will receive a standard non-weighted pacifier for 48 hours of their stay in the NICU.
Interventions
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.
The non-weighted pacifier is a standard of care pacifier that a neonate would receive if they were not part of this study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Englewood Health
Englewood, New Jersey, 07631, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2019
First Posted
September 19, 2019
Study Start
September 19, 2019
Primary Completion
November 18, 2021
Study Completion
November 18, 2021
Last Updated
July 26, 2022
Record last verified: 2022-07