A 6-month Study on the Feasibility, Safety, and Tolerability of a Silicone Myofunctional Infant Pacifier

Keystone OrthotropiX30 enrolled

Overview

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.

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Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Feasibility, Safety and Tolerability of Device

Interventions

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.

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 1 MonthHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Feasibility of device use

Categorical (Yes/No) feasibility is defined as BREATHE myofunctional pacifier use beyond 2 months of age

Time frame: 2 months

Acceptability of device use

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.

Time frame: 6 months

Secondary Outcomes

Safety of the device use

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.