Weighted Pacifier Vs. Non-Weighted Pacifier

NCT ID: NCT04095702

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2021-11-18

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.

Conditions

Non-nutritive Sucking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Weighted Pacifier

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

Group Type: EXPERIMENTAL

Weighted Pacifier

Intervention Type: OTHER

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.

Non-Weighted Pacifier

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

Group Type: PLACEBO_COMPARATOR

Non-Weighted Pacifier

Intervention Type: OTHER

The non-weighted pacifier is a standard of care pacifier that a neonate would receive if they were not part of this study.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Englewood Hospital and Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Englewood Health

Englewood, New Jersey, United States

Countries

United States

Other Identifiers

E-19-782

Identifier Type: -

Identifier Source: org_study_id