Skip to main content

Table 1 Timeline of the study and clinical data collection

From: Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial

TIMEPOINTStudy Period
EnrollmentAllocationPost-allocation
Birth to 00Surfactant administration (-10min-+10min)72 hours after birthAt 36 weeks PMA or at discharge
Enrolment:
Eligibility screenX    
Informed consentX    
Allocation X   
Intervention
 LISA  XXX
 LPPSA  XXX
Assessments
Primary outcomes
 1.Need for ventilation during the first 72 hours
   X 
 2. Mortality
 3. BPD
    X
Secondary outcomes
Need for and the duration of MV (days), duration (days) of non-invasive respiratory support, severe co-morbidities, pneumothorax, massive pulmonary hemorrhage within 48 h of surfactant administration, hemodynamically significant patent ductus arteriosus that needs medical or surgical intervention,
Duration of hospitalization,
Failure rate of LISA or LPPSA
  XXX
  1. LPPSA surfactant administration followed by low peak pressure, LISA less invasive surfactant administration