Non-nutritive SuckingNCT04095702
Weighted Pacifier Vs. Non-Weighted Pacifier
A study testing Weighted Pacifier and Non-Weighted Pacifier in people with Non-nutritive Sucking, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
This study will determine if it is beneficial to use a weighted pacifier in neonates. Read more about this study
- Who is it for?
- Ages 30 to 37 weeks
- Conditions the study is for
- Non-nutritive Sucking
- What is being tested?
- Weighted Pacifier and Non-Weighted Pacifier
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2019to 18 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will determine if it is beneficial to use a weighted pacifier in neonates.
Read the 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
- Being tested
- Weighted Pacifier, Non-Weighted Pacifier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted PacifierOther
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 PacifierOther
The non-weighted pacifier is a standard of care pacifier that a neonate would receive if they were not part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Weighted Pacifier | Experimental | Patient will receive a weighted pacifier for 48 hours of their stay in the NICU. Receives: Other: Weighted Pacifier |
| Non-Weighted Pacifier | Placebo comparator | Patient will receive a standard non-weighted pacifier for 48 hours of their stay in the NICU. Receives: Other: Non-Weighted Pacifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 48 hours
Secondary outcomes (2)
Stress/ Discomfort determined by a Likert Scale
To determine if a stabilized pacifier reduces infant stress/discomfort
Measured: 48 hours
Caregiver stress determined by a Likert Scale
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start19 Sep 2019
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-nutritive SuckingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095702
- Sponsor's protocol ID
- E-19-782
- Status last verified
- Jul 2022
- First submitted
- 22 Aug 2019
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04095702
- Acronym / sponsor ID
- E-19-782
- Conditions
- Non-nutritive Sucking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted Pacifier | Experimental | Other: Weighted PacifierPatient will receive a weighted pacifier for 48 hours of their stay in the NICU. |
| Non-Weighted Pacifier | Placebo comparator | Other: Non-Weighted PacifierPatient will receive a standard non-weighted pacifier for 48 hours of their stay in the NICU. |
Who may qualify
- Ages
- 30 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted PacifierThe 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. | Other | Weighted Pacifier |
| Non-Weighted PacifierThe non-weighted pacifier is a standard of care pacifier that a neonate would receive if they were not part of this study. | Other | Non-Weighted Pacifier |
Primary outcome
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.
2 secondary outcomes
Stress/ Discomfort determined by a Likert Scale
Time frame: 48 hours
Caregiver stress determined by a Likert Scale
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Related trials for Non-nutritive Sucking
Recruiting
Feeding Maturity in Preterm Infants
Preterm, Feeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Pacifier and Non-Weighted Pacifier in people with Non-nutritive Sucking, run by Englewood Hospital and Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety determined by a Neonatal Infant Pain Scale (NIPS) score (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022; AzTrials last refreshed its copy on 26 Oct 2026.