A clinical trial to study the effects of two methods of surfactant administration, through Laryngeal mask airway and endotracheal tube in preterm babies with Respiratory distress syndrome
Phase 2
- Conditions
- Health Condition 1: null- Respiratory distress syndrome
- Registration Number
- CTRI/2016/12/007540
- Lead Sponsor
- Dr Ramkumaar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 176
Inclusion Criteria
1.Birth weight of more than 1200 grams
2.Gestational age of more than 30 weeks
3.Chronological age of less than 48 hours
4.Diagnosis of RDS with clinical and radiological criteria
5.Requiring nasal CPAP with Peep of less than 7 and FiO2 between 0.4 to 0.7
6.Hemodynamically stable
A written consent will be obtained from the parents / care givers of the infant for willingness for enrolment in the study
Exclusion Criteria
1.Babies who underwent Endotracheal intubation earlier
2.Analgesia & or sedation during first 6 hours of life
3.APGAR score of less than 3 at 5 minutes of life
4.Babies with Major congenital anomalies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eed for mechanical ventilation within 48 hours of interventionTimepoint: 48 hours
- Secondary Outcome Measures
Name Time Method 1.Any need for mechanical ventilation <br/ ><br>2.Evaluation of pain (Neonatal Infant Pain score) <br/ ><br>3.Duration of oxygen requirement <br/ ><br>4.Rate of pneumothorax <br/ ><br>5.Compilations related to the intervention <br/ ><br>6.Incidence of Sepsis <br/ ><br>7.MortalityTimepoint: Till the time of discharge