Weighted Pacifier Vs. Non-Weighted Pacifier
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04095702|
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-nutritive Sucking||Other: Weighted Pacifier Other: Non-Weighted Pacifier||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||September 19, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
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.
- 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.
- Stress/ Discomfort determined by a Likert Scale [ Time Frame: 48 hours ]To determine if a stabilized pacifier reduces infant stress/discomfort
- Caregiver stress determined by a Likert Scale [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095702
|United States, New Jersey|
|Englewood, New Jersey, United States, 07631|
|Contact: Jamie Ketas 201-894-3418 Jamie.Ketas@EHMCHealth.org|