TPP: For aerosolized surfactant therapy in neonates with respiratory distress syndrome in low and middle income countries
Target product profile for aerosolized surfactant therapy in neonates with respiratory distress syndrome in low- and middle-income countries
Target product profile (TPP) for the minimal and optimal characteristics of an aerosolised surfactant that can be used for neonates (aged 0-28 days) with respiratry distress syndrome (RDS) in low and middle income countries (LMICs).
Minimal: Treatment of RDS not responding to use of noninvasive respiratory support devices (NRS) (e.g. CPAP)
Optimal: Treatment of RDS regardless of use of noninvasive respiratory support devices (NRS) (e.g. CPAP)
Minimal: Neonates > 1000g birth weight or > 28 weeks gestational age with RDS
Optimal: Any neonate with RDS
Target facilities in LMIC
Minimal: Facilities providing level 2 special care and able to refer to level 3 facilities
Optimal: Facilities providing level 2 special care regardless of referral network
Initiation time
Minimal: If treatment of infant with RDS is started up to 12 hours after birth it will still have maximum effect
Optimal: If treatment of infant with RDS is started up to 48-72 hours after birth it will still have maximum effect
Frequency
Minimal: Needs no more than 3 doses for maximum effect equivalent to current preparations
Optimal: Needs only one dose for maximum effect
Dose calculation
Minimal: Dosing is ml/kg body weight
Optimal: Dose is independent of body weight or calculated in ‘bands’ of body weight (e.g. <0.5kg, 0.6-1.0kg, 1.1-1.5kg etc.)
Time of onset of effect
Minimal: Must have measurable clinical improvement (such as improved oxygenation, reduced
Optimal: Must have measurable clinical improvement within 15 min of treatment completion