Feasibility, Safety and Tolerability of Device
Conditions
Keywords
myofunctional therapy, pacifier, infants, palatal morphology, safety, acceptability, phase 1
Brief summary
The goal of this interventional feasibility study is to learn about the feasibility, acceptability, and safety of a novel myofunctional pacifier in infants from birth to 6 months of age. The pacifier is designed to mimic the maternal nipple, which may improve the structures of the mouth and nose to prevent problems caused by standard pacifiers. Long-term use of standard pacifiers has been associated with abnormal orthodontics, ear infections, and even sleep apnea in young children. The main question the study aims to answer is: Will infants accept the new pacifier, and are there any problems with its use? Participants will be followed for 6 months and have digital scans of their oral cavity every three months to monitor the palate's development.
Detailed description
See information elsewhere in this record
Interventions
DEVICEBREATHE myofunctional pacifier
The BREATHE myofunctional pacifier is a prototype silicone pacifier designed for infant use. This feasibility study evaluates infant use, acceptability, tolerability, and safety of the prototype. Potential effects on palatal morphology and other oral health outcomes will be evaluated in a subsequent clinical trial and are not primary outcomes of the present feasibility study.
Sponsors
Keystone OrthotropiX
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
The device is a simple silicone myofunctional pacifier. Pacifiers are not regulated by the FDA. For this reason, more than 20 infants were recruited. After this trial, we intend to conduct full clinical trials to study the device's potential health benefits.
Eligibility
Sex/Gender
ALL
Age
0 Months to 1 Months
Healthy volunteers
Yes
Inclusion criteria
* healthy infants with documented, high Apgar scores (7-10) * ages 0 months or less than 1 month * vaginal or Cesarean section births * breast-fed or bottle-fed
Exclusion criteria
* premature babies (lower than 35 weeks' gestation) * low Apgar scores (less than 7) * cleft issues * craniofacial syndromes * neurological diseases * upper airway anomalies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of device use | 2 months | Categorical (Yes/No) feasibility is defined as BREATHE myofunctional pacifier use beyond 2 months of age |
| Acceptability of device use | 6 months | Usage of the pacifier as measured in hours/day. An average use of more than 2.1 hours per day during the first 6 months of life will be considered high acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the device use | 6 months | Study staff will examine the participants for, and caregivers will report any of the following potential adverse outcomes: oral ulceration, gingival trauma, pain, temporomandibular joint symptoms, aspiration or choking incidents, sleep disruption, airway compromise, device breakage, or allergic reactions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNafys Samandari, DDS
Keystone OrthotropiX
Outcome results
None listed