Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05714865
Status:
RECRUITING
Last Update Posted:
2023-08-18
First Post:
2022-12-28
Brief Title:
Implementing LISA Surfactant in Nigeria
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Less Invasive Surfactant Administration in Nigeria
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Implement surfactant BLES replacement therapy using the Less Invasive Surfactant Administration technique in six tertiary institutions in Nigeria and evaluate its impact on 72-hour neonatal mortality in premature infants born less than 2000 grams at birth
Detailed Description:
Background In low- and middle-income countries LMICs respiratory distress syndrome RDS accounts for 45 of all in-hospital neonatal mortality Surfactant use is limited in LMICs in part due to the high cost the lack of skill to perform laryngoscopy and tracheal intubation and perhaps a perception that surfactant administration and mechanical ventilation must occur together In LMICs continuous positive airway pressure CPAP is often the highest mode of respiratory support available and CPAP failure invariably means death If Less Invasive Surfactant Administration LISA can reduce CPAP failure as shown in high-income settings it potentially can reduce prematurity-related neonatal mortality in LMICs There are however no studies on how to safely implement LISA in LMICs The LISA procedure is novel in LMICs the procedure is not without risk severe and minor laryngoscopy is a difficult skill to acquire master and maintain and the resource limitations in LMICs need consideration while implementing LISA
Hypothesis Compared to a historical control introducing non-invasive surfactant administration through the less invasive surfactant administration LISA techniques will result in a relative risk reduction of all-cause 72-hour in-hospital mortality by at least 20
PICO Outline
Population Preterm infants 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of 4 who are spontaneously breathing and on CPAP
Intervention Surfactant administered through the less invasive surfactant administration LISA technique
Comparator A historical control of preterm babies 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of 4 who are spontaneously breathing and on CPAP
Outcome measures
Primary Outcome 72-hour all-cause in-hospital mortality
Secondary outcomes
All-cause in-hospital mortality
Change in respiratory distress score pre- to -post interventions
Hypothesis Compared to a historical control introducing non-invasive surfactant administration through the less invasive surfactant administration LISA techniques will result in a relative risk reduction of all-cause 72-hour in-hospital mortality by at least 20
PICO Outline
Population Preterm infants 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of 4 who are spontaneously breathing and on CPAP
Intervention Surfactant administered through the less invasive surfactant administration LISA technique
Comparator A historical control of preterm babies 2 kg with respiratory distress defined by a Downes Respiratory Distress Score of 4 who are spontaneously breathing and on CPAP
Outcome measures
Primary Outcome 72-hour all-cause in-hospital mortality
Secondary outcomes
All-cause in-hospital mortality
Change in respiratory distress score pre- to -post interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None