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

A 6-month Study on the Safety and Tolerability of a Silicone "Orthotropic" Infant Pacifier

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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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.