Clinical Usability Study of breathing support device (CPAP) for newborns
- Conditions
- Health Condition 1: P220- Respiratory distress syndrome of newborn
- Registration Number
- CTRI/2022/07/044057
- Lead Sponsor
- Equalize Health India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
(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 < 7.2) Detection of the presence of exclusion criteria post enrolment will lead to exclusion from study and analysis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method