Study to evaluate safety and performance of nice Neotechâ??s Bubble CPAP System in treating newborn respiratory distress syndrome (RDS)
- Conditions
- Health Condition 1: P220- Respiratory distress syndrome of newborn
- Registration Number
- CTRI/2022/04/042207
- Lead Sponsor
- nice Neotech Medical Systems Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Subjects with Parental informed consent.
-Subjects indicated for Respiratory support using Bubble CPAP
-Subject with Respiratory Distress Syndrome related to prematurity
-Subject with Gestational age <37 weeks and specifically those requiring CPAP administration and presenting to the study site no later than 24 hours after birth
Subjects may be in-born (at the study site) or out-born (born at another hospital and transferred within the first 24 hours)
-Lack of Parental / Informed consent
-Subjects with known congenital anomalies necessitating intubation
-Genetic anomalies, Congenital Heart Defects (not including PDAs, small ASDs, small VSDs)
-Prenatally diagnosed pulmonary hypoplasia
-Subjects with perinatal asphyxiation, sepsis or severe hemodynamic instability
Subjects presenting with any contraindications to Bubble CPAP therapy (or indications for mechanical ventilation) within the first 24 hours of life will be excluded from participation including: apnea (defined as >= 8 episodes within 24 hours or any episode with accompanied bradycardia) or poor spontaneous respiratory effort, shock, massive pulmonary hemorrhage, severe metabolic acidosis (pH -10), severe respiratory acidosis (pH 55mmHg).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method