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Trial record 1 of 1 for:    04095702
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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
Sponsor:
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

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

Condition or disease Intervention/treatment Phase
Non-nutritive Sucking Other: Weighted Pacifier Other: Non-Weighted Pacifier Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Stress/ Discomfort determined by a Likert Scale [ Time Frame: 48 hours ]
    To determine if a stabilized pacifier reduces infant stress/discomfort

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, New Jersey
Englewood Health Recruiting
Englewood, New Jersey, United States, 07631
Contact: Jamie Ketas    201-894-3418    Jamie.Ketas@EHMCHealth.org   
Sponsors and Collaborators
Englewood Hospital and Medical Center

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Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT04095702    
Other Study ID Numbers: E-19-782
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms