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Clinical trial

Less Invasive Surfactant Administration in Nigeria

ID
Name
NHREC/01/01/2007-12/10/2022
Description
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.
Trial arms
Trial start
2023-06-25
Estimated PCD
2024-06-30
Trial end
2024-09-30
Status
Recruiting
Phase
Early phase I
Treatment
Surfactant
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
Arms:
LISA Arm
Other names:
BLES® Surfactant, BLEScath™, Less Invasive Surfactant Administration
Size
600
Primary endpoint
72-hour mortality
72 hours of life
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective cohort', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}
Updated at
2023-08-18

1 organization

1 product

2 indications

Organization
Indiana University
Product
Surfactant
Indication
Respiratory Distress Syndrome
Indication
Neonatal Death