Neonatal Death, Respiratory Distress Syndrome
Conditions
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.
Interventions
DRUGSurfactant
Laryngoscopy is performed, and BLES® surfactant is administered through BLEScath™ (a thin catheter) into the trachea to a spontaneously breathing preterm infant with respiratory distress syndrome who is being managed on CPAP
Sponsors
BLES Biochemicals Inc.
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective cohort
Eligibility
Sex/Gender
ALL
Age
1 Hours to 2 Days
Healthy volunteers
No
Inclusion criteria
* Newborns with birth weight between 500-2000 grams (determined by birth weight or admission weight if birth weight is unavailable). * ≤48 Hours old at recruitment. * Spontaneously breathing but have clinical signs of respiratory distress (defined by Anderson Silverman Score (ASS) ≥4 (range 0-10)) and on CPAP. * Admitted to the neonatal/newborn units (or special care nurseries).
Exclusion criteria
* Any newborn intubated before admission to the neonatal/newborn units. * Any newborn infants with a significant congenital abnormality * Any preterm infant considered nonviable by the managing clinician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 72-hour mortality | 72 hours of life | All cause mortality with 72-hours of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | Through hospitalization, an average of 1 day to 10 weeks. | All cause mortality during hospitalization |
| Difference in RDS score before and after the procedure. | 6 hours post procedure | Change in Anderson Silverman RDS Score before and after intervention (range: 0 to 10) |
Countries
Nigeria
Outcome results
None listed