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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-nutritive Sucking
- Sponsor
- Englewood Hospital and Medical Center
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Safety determined by a Neonatal Infant Pain Scale (NIPS) score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety determined by a Neonatal Infant Pain Scale (NIPS) score
Time Frame: 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
Time Frame: 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 Outcomes
- Stress/ Discomfort determined by a Likert Scale(48 hours)
- Caregiver stress determined by a Likert Scale(48 hours)