Health Condition 1: Q355- Cleft hard palate with cleft softpalate
Conditions
Interventions
Intervention1: T bingen Palatal Plate: The T bingen Palatal Plate (TPP) is a specialized orthodontic device designed to help infants with Robin Sequence (RS) by repositioning the tongue forward, impro
Sponsors
Hemwat Nandan
GSR Institute of Craniofacial Surgery Hyderabad
Eligibility
Inclusion criteria
Inclusion criteria: 1) Diagnosis of Robin Sequence (RS): Infants with mandibular retrognathia, glossoptosis, and upper airway obstruction 2) Breathing difficulties: infants experiencing significant challenges inbreathing due to tongue positioning 3) Medically fit for treatment 4) One parent/guardian a native language speaker 5) Signed informed consent
Exclusion criteria
Exclusion criteria: 1) Consent not obtained 2) Isolated cleft of hard and soft palate without any breathing difficulty 3) Unilateral complete cleft of lip, alveolus hard and soft palate 4) Bilateral complete cleft of lip, alveolus hard and soft palate 5) Congenital hearing loss or structural middle ear anomalies 6) A congenital heart defect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement in upper airway obstructionTimepoint: Start of plate intervention at T1 (0 to 20 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight GainTimepoint: 1) At birth T0 (at time of birth) 2) Start of plate intervention at T1 (0 to 20 days) 3) At end of plate intervention at T2 (6 month of age) 4) At 1 year at T3 (1 years of age) | — |
Countries
India
Contacts
Public ContactHemwati Nandan
GSR Institute of Craniofacial and Facial Plastic Surgery Hyderabad
Outcome results
None listed