Health Condition 1: P220- Respiratory distress syndrome of newborn
Conditions
Interventions
Intervention1: Alveofact (Bovectant) (SF-RI1): Neonates randomized to Alveofact group will receive initial dose of surfactant replacement therapy as 100 mg/kg (2.4 ml/kg) of Alveofact surfactant (dosa
Sponsors
Department of Neonatology
Eligibility
Inclusion criteria
Inclusion criteria: 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%
Exclusion criteria
Exclusion criteria: 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The need for mechanical ventilation within 72 hours of lifeTimepoint: Within 72 hours of life | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 ;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 | — |
Countries
India
Contacts
Public ContactMangala Bharathi S
Institute of Obstetrics and gynecology, Madras Medical college, Chennai
Outcome results
None listed