Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554522
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pragmatic Evaluation of Therapies to Enhance Respiratory Management in Preterm Infants in Africa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable It will also learn about the safety of the less invasive surfactant administration LISA technique The main questions it aims to answer are
Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique
Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant
Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will
Receive surfactant replacement therapy by the less invasive surfactant administration technique
Be monitored for complications Be followed throughout their hospitalization to determine their survival rate
Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique
Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant
Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will
Receive surfactant replacement therapy by the less invasive surfactant administration technique
Be monitored for complications Be followed throughout their hospitalization to determine their survival rate
Detailed Description:
The low- and middle-income countries of Sub-Saharan Africa SSA carry the highest burden of preterm births and deaths A primary driver of preterm mortality in SSA is respiratory distress syndrome Surfactant replacement therapy by the less invasive surfactant administration LISA is a technique where the surfactant is administered to a preterm neonate with respiratory distress syndrome managed on continuous positive airway pressure CPAP reducing the need for using an invasive mechanical ventilator In high-income countries LISA has been shown to be effective in reducing the need for invasive mechanical ventilators and mortality However the impact of LISA is unknown in low-resourced settings without ventilators
The central hypothesis is that implementing LISA in newborn units that care for preterm neonates using standardized CPAP and caffeine citrate will improve survival in preterm neonates
PICO Outline
Population Preterm neonates 750 and 2000 grams or gestational age between 24- and 35 weeks at birth with respiratory distress defined by a Silverman Anderson Score of 5 who are spontaneously breathing and on CPAP
Intervention Surfactant administered through the less invasive surfactant administration LISA technique
Comparator Standard of care - standardized CPAP and Caffeine
Outcome measures Primary Outcome All-cause in-hospital survival
The central hypothesis is that implementing LISA in newborn units that care for preterm neonates using standardized CPAP and caffeine citrate will improve survival in preterm neonates
PICO Outline
Population Preterm neonates 750 and 2000 grams or gestational age between 24- and 35 weeks at birth with respiratory distress defined by a Silverman Anderson Score of 5 who are spontaneously breathing and on CPAP
Intervention Surfactant administered through the less invasive surfactant administration LISA technique
Comparator Standard of care - standardized CPAP and Caffeine
Outcome measures Primary Outcome All-cause in-hospital survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None