Arterial carbon dioxide level after brief ventilation using self inflating bag versus T- piece resuscitator following surfactant therapy
Phase 3
Completed
- Conditions
- Health Condition 1: null- Preterm infants with respiratory distress syndrome and FiO2 requirement of 30% needing first dose of surfactant admitted to Surya Childrenâ??s Hospital NIC
- Registration Number
- CTRI/2015/08/006067
- Lead Sponsor
- Surya Children Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
preterm infants with respiratory distress requiring 1st dose of surfactant
Exclusion Criteria
Antenatally diagnosed congenital heart disease such as complex cyanotic heart disease
Infants who have received first dose of surfactant prior to transfer to the hospital
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in arterial CO2 pre and post surfactant administration in SIB (Self inflating bag) versus TPR (T-Piece Resuscitator) group <br/ ><br>Timepoint: 30 minutes
- Secondary Outcome Measures
Name Time Method Duration of hospital stay (days)Timepoint: at the time of discharge from NICU;Duration of oxygen therapy (days)Timepoint: 28 days;Duration of respiratory support (days)Timepoint: 28 days;Incidence of air leak/Pneumothorax (%)Timepoint: 28 days;Incidence of Bronchopulmonary Dysplasia BPD (%)Timepoint: at 36 weeks of post conceptional age;Incidence of Intraventricular Hemorrhage -IVH and Periventricular leucomalacia PVL (%)Timepoint: 28 days;Incidence of Necrotising Enterocolitis -NEC (%)Timepoint: 28 days;Incidence of Retinopathy of prematurity ROP (%)Timepoint: at the time of discharge from NICU;Mean PaCO2 six hours post surfactant administration (mm Hg)Timepoint: 6 hours;Mean PaO2 six hours post surfactant administration (mm Hg)Timepoint: 6 hours;Requirement of assisted ventilation (%)Timepoint: 1st week of life;Type of respiratory support required (%)Timepoint: 1st week of life