Health Condition 1: P220- Respiratory distress syndrome of newborn
Conditions
Interventions
Intervention1: Delivery of CPAP therapy: Delivery of CPAP therapy solely as prescribed by treating physician per standard protocols using FlowLite Neonatal CPAP device. No other intervention or inves
Sponsors
Equalize Health India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Gestational age 28 weeks or more, specifically those requiring CPAP administration and presenting to the study site no later than 24 hours after birth. The indications for CPAP prescription by clinician may include RDS related to prematurity, TTN, MAS or any other appropriate indication except those listed in exclusion criteria.
Exclusion criteria
Exclusion criteria: (i) Weight less than 1 kg or GA less than 28 weeks. Known genetic and congenital anomalies necessitating intubation (eg Pierre Robin sequence cleft lip/palate syndrome esophageal atresia) congenital heart defects (excl. PDAs small ASDs small VSDs) prenatally diagnosed pulmonary hypoplasia and Perinatal asphyxiation severe hemodynamic instability (ii) Any contraindications to CPAP therapy (or indications for IMV) within the first 24 hours of life apnea poor spontaneous respiratory effort shock massive pulmonary hemorrhage severe acidemia (pH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the ability of NICU staff to correctly connect configure monitor and manage CPAP therapy using the FlowLite Neonatal CPAP deviceTimepoint: During the time of CPAP Therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To constantly monitor for identify and document any unintended adverse effects potentially attributable to device function or interaction between device and user device and patient and device and environmentTimepoint: End of hospitalization | — |
Countries
India
Contacts
Public ContactDr Somashekhar Nimbalkar
Pramukhswami Medical College, Bhaikaka University, Karamsad, Anand, Gujarat
Outcome results
None listed