Health Condition 1: P220- Respiratory distress syndrome of newborn
Conditions
Interventions
None listed
Sponsors
nice Neotech Medical Systems Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -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 Subjects may be in-born (at the study site) or out-born (born at another hospital and transferred within the first 24 hours)
Exclusion criteria
Exclusion criteria: -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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weaned off Bubble CPAP / intubation followed by recovery and discharge/ intubation followed by deterioration and death / other.Timepoint: At the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Observation of any unexpected adverse events happenedTimepoint: At the end of treatment. | — |
Countries
India
Contacts
Public ContactBalasubramani
nice Neotech Medical Systems Pvt. Ltd.
Outcome results
None listed