None listed
Conditions
Interventions
Procedure/Surgery : In this study, a customized intraoral appliance, Orthodontic Airway Plate (OAP), will be applied in neonates with mandibular deficiency and airway obstruction. The appliance will b
Sponsors
Yonsei University Health System, Dental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be eligible for inclusion: 1) Neonates within 1 month after birth with mandibular deficiency - Mandibular deficiency will be defined based on the investigator’s comprehensive assessment of clinical findings (including mandibular retrusion and glossoptosis) and radiologic evaluation, including patients with Pierre Robin Sequence. 2) Presence of upper airway obstruction symptoms or feeding difficulty, including: - respiratory distress - cyanosis - apnea - feeding difficulty 3) Neonates considered physically suitable for intraoral appliance treatment - gestational age =34 weeks and birth weight =2 kg 4) Written informed consent obtained from the caregivers
Exclusion criteria
Exclusion criteria: 1) Presence of severe comorbid conditions, including: - severe congenital heart disease - severe neurologic disorders (e.g., intracranial malformations, hypoxic-ischemic encephalopathy, periventricular leukomalacia, etc.) (Patients with mild neurologic abnormalities may be included if the investigator judges them to be clinically stable with a favorable prognosis.) - other conditions that may interfere with interpretation of the study results, as determined by the investigator (e.g., central apnea) 2) Patients considered unsuitable for nonsurgical intraoral appliance treatment due to unstable general condition - requirement for mechanical ventilation due to pulmonary disease - hemodynamic instability - unstable systemic condition due to infection 3) Suspected or confirmed airway obstruction below the nasopharyngeal level (e.g., severe tracheomalacia or subglottic stenosis identified on bronchoscopy) 4) Previous invasive airway intervention, including: - tracheostomy - mandibular distraction osteogenesis (MDO) - tongue-lip adhesion (TLA) 5) Cases in which caregiver cooperation is considered insufficient or follow-up is considered not feasible by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate of nonsurgical airway management | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in oxygen saturation (SpO2);Change in the need for and level of respiratory support;Change in frequency of apnea episodes;Change in feeding ability and nasogastric tube dependence;Change in weight gain rate and growth trajectory;Need for and timing of additional surgical airway intervention | — |
Countries
Korea, Republic of
Contacts
Public ContactHwangyu Lee
Yonsei University Health System, Dental Hospital
Outcome results
None listed