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Table 2 Explanatory variables divided by experimental group and control group participants

From: Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants

Variables

Experimental group (n)

Control group (n)

At randomisation

 Birth weight (g)

  

 Gestational age (weeks)

  

 Apgar 1 min (1–10)

  

 Apgar 5 min (1–10)

  

 Gender

  

  Male (%)

  

  Female (%)

  

At 72 h of age

 Age when NIRS monitoring started (h)a

 

N/A

 Stopping NIRS monitoring before end of monitoring period (%)a

 

N/A

 Parents discontinuing trial participation (%)

  

 Changes in treatment due to cerebral hypoxia (%)a

 

N/A

 Registered cardiovascular support treatment (%)a

 

N/A

 Type of NIRS device useda

  INVOS (%)

  NIRO (%)

  Fore-Sight (%)

  Sensmart (%)

  O3 (%)

  Egos (%)

  Oxyprem (%)

  Other (%)

 

N/A

 Cerebral NIRS monitoring despite being in control group (%)b

N/A

 

 Surfactant therapy (%)

  

 Severe adverse reactions (%)

  

At 36 weeks postmenstrual age

 Major congenital anomaly (%)

  

 Mechanical ventilation (%)

  

 Time with mechanical ventilation (days)

  

 Patent ductus arteriosus (%)

  

 Weight (g)

  

 Early cranial ultrasound scan (%)

  

 Late cranial ultrasound scan (%)

  
  1. Data expressed as median (range) for continuous variables, and numbers (percentage) for dichotomous variables
  2. N/A not applicable, NIRS near-infrared spectroscopy
  3. aVariables only relevant for experimental group participants
  4. bVariables only relevant for control group participants