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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

TIMEPOINT

Study Period

Enrollment

Allocation

Post-allocation

Birth to 0

0

Surfactant administration (-10min-+10min)

72 hours after birth

At 36 weeks PMA or at discharge

Enrolment:

Eligibility screen

X

    

Informed consent

X

    

Allocation

 

X

   

Intervention

 LISA

  

X

X

X

 LPPSA

  

X

X

X

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

  

X

X

X

  1. LPPSA surfactant administration followed by low peak pressure, LISA less invasive surfactant administration