A study to evaluate the benefits of an alternative method of breathing support to premature babies with breathing difficulty.
Not Applicable
Not yet recruiting
- Conditions
- Health Condition 1: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2023/06/053497
- Lead Sponsor
- Vishal Vishnu Tewari
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All preterm neonates at and below 32 weeks period of gestation with moderate to severe RDS serially admitted to the NICU of Command hospital (WC), Chandimandir will be included in the study.
Exclusion Criteria
Neonates with major congenital anomalies, congenital heart diseases, gestation at and below 24 weeks or greater than 32 weeks, preterm neonates at and below 32 weeks with mild RDS not requiring intratracheal surfactant and neonates intubated at delivery for resuscitation.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine short-term respiratory outcomes in preterm neonates at 32 weeks & below with respiratory distress syndrome (RDS) given intratracheal surfactant by less invasive surfactant administration (LISA) technique measured as duration of respiratory support in hours.Timepoint: To determine short-term respiratory outcomes in preterm neonates at 32 weeks & below with respiratory distress syndrome (RDS) given intratracheal surfactant by less invasive surfactant administration (LISA) technique measured as duration of respiratory support in hours.
- Secondary Outcome Measures
Name Time Method 1.To determine the required number of doses of surfactant per patient <br/ ><br>2.To determine the failure of LISA technique <br/ ><br>3.To determine the procedure success rate <br/ ><br>4.Incidence of mortality, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), patent ductus arteriosus (PDA), necrotizing enterocolitis (NEC) & retinopathy of prematurity (ROP)Timepoint: By day of discharge from the hospital