Health Condition 1: Q359- Cleft palate, unspecified
Conditions
Interventions
Intervention1: Feeding aid for Infants with cleft palate: A specially designed feeding bottle incorporating a soft palate occluder that temporarily separates the oral and nasal cavities during feeding
Sponsors
Saveetha medical college and hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1 Infants aged 0 to 6 months till 1year with diagnosed cleft lip and or cleft palate awaiting surgical repair 2 Difficulty in feeding confirmed by caregiver or clinical observation such as poor intake frequent nasal regurgitation 3 Medically stable and able to attempt oral feeding. 4 Informed parental consent obtained
Exclusion criteria
Exclusion criteria: 1 Syndromic clefts with associated severe comorbidities such as cardiac anomalies neurological conditions affecting swallowing 2 Infants requiring bottle feeding for other reasons such as non medical reasons 3 Infants with recurrent pneumonia more than 2 hospitalisation 4 Known severe allergy to medical-grade silicone/plastics used in device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feeding bottle with occluder will demonstrate reduced feeding time fewer nasal regurgitation episodes and improved weight gain compared with conventional methodsTimepoint: At birth for baseline and then at 2 weeks 4 weeks 8 weeks 12 weeks of age | — |
Secondary
| Measure | Time frame |
|---|---|
| The intervention will lower risk of aspiration & feeding associated respiratory infections The device may prove cost effective user friendly & scalable for use in low resource settingsTimepoint: At birth for baseline & then at 2 weeks 4 weeks 8 weeks 12 weeks of age | — |
Countries
India
Contacts
Public ContactPRADEEP S
Saveetha medical college and hospital
Outcome results
None listed