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Clinical trial

Prophylactic Minimally Invasive Surfactant Evaluation

ID
Name
EH23-107
Description
The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?
Trial arms
Trial start
2024-01-01
Estimated PCD
2025-12-31
Trial end
2027-07-31
Status
Recruiting
Phase
Early phase I
Treatment
Poractant Alfa
Poractant alfa (Curosurf) 200mg/kg administered under direct laryngoscopy using a surfactant instillation catheter
Arms:
Prophylactic Surfactant via Minimally Invasive Technique, Rescue Surfactant via Minimally Invasive Technique
Other names:
Minimally Invasive Surfactant Therapy
Size
200
Primary endpoint
Endotracheal Intubation
7 days
Eligibility criteria
Inclusion Criteria: * Gestational age \<30 weeks * Antenatal consent from Parent Exclusion Criteria: * Congenital anomalies * Alternate cause of respiratory distress
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison of prophylaxis compared to rescue surfactant, administered using a minimally invasive technique, in premature infants less that 30 weeks gestation', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-02-21

1 organization

1 product

3 indications

Organization
NorthShore University HealthSystem
Product
Poractant Alfa
Indication
Respiratory Distress Syndrome
Indication
Newborn
Indication
Preterm Birth