A study to compare two different types of surfactant for treating respiratory difficulty due to lack of surfactant in preterm babies.
- Conditions
- Health Condition 1: P220- Respiratory distress syndrome of newborn
- Registration Number
- CTRI/2023/04/051351
- Lead Sponsor
- Department of Neonatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Preterm neonates of 28 to 34 completed weeksâ?? gestation age, with clinical features of RDS developing within 6 hours of birth and fulfilling the criteria to receive surfactant therapy within 24 hour of birth. The criteria for initial dose of Surfactant Replacement Therapy (SRT) will be: FiO2 requirement 30% or higher while on continuous positive airway pressure (CPAP) with PEEP of 6 mm Hg to maintain oxygen saturation between 90 and 94%
1) Infants who require mechanical ventilation or intubation in the delivery room or before the initial surfactant dose.
2) Use of surfactant prior to study entry.
3) Significant perinatal asphyxia defined as 5 min Apgar score of < 4 or need for chest compressions during resuscitation or metabolic acidosis (pH < 7.0) in umbilical arterial blood gas or arterial blood gas obtained within 1 hour of life.
4) Major life threatening congenital anomalies or anomalies interfering with lung development or function.
5) Patients, whose parents or legal representative not giving consent for the s
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The need for mechanical ventilation within 72 hours of lifeTimepoint: Within 72 hours of life
- Secondary Outcome Measures
Name Time Method Blood culture proven sepsisTimepoint: Till discharge or death;BPDTimepoint: Till discharge or death;Duration of hospital stayTimepoint: Till discharge or death;Duration of respiratory supports (invasive and non-invasive)Timepoint: Till discharge or death;IVH- grade 3 or 4Timepoint: Till discharge or death;Mortality <br/ ><br> <br/ ><br>Timepoint: Before discharge;Need for second dose of SurfactantTimepoint: Within 72 hours of life;NNEC- modified Bells stage 2 or aboveTimepoint: Till discharge or death;PDA requiring medical or surgical treatmentTimepoint: Till discharge or death;Procedural effects associated with LISATimepoint: Surfactant reflux, desaturation (SpO2 below 80%), bradycardia (Heart rate 100 bpm) and apnea during surfactant administration <br/ ><br>;Pulmonary hemorrhageTimepoint: Within 48 hours of surfactant therapy;Rate of Pulmonary Air leak syndromesTimepoint: Within 72 hours of surfactant therapy;ROP requiring treatmentTimepoint: Till discharge or death