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Table 1 Schedule of enrolment, interventions, and assessment

From: Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial

Activity/assessment

Staff member

Approximate time to complete

Before delivery

t0

t1

t2

t3

t4

t5

t6

t7

t8

t9

t10

t11

t12

t13

t14

Informed consent

Neonatal nurse/physician

15 minutes

x

               

Inclusion/exclusion form

Neonatal nurse

5 minutes

 

x

              

Randomization sealed envelopes

Neonatal nurse

1 minute

  

x

             

Heart rate

Neonatal nurse

30 sec

   

x

x

x

x

x

        

Respiration rate

Neonatal nurse

30 sec

   

x

x

x

x

x

        

Oxygen saturation

Neonatal nurse

30 sec

   

x

x

x

x

x

        

Body temperature

Neonatal nurse

30 sec

   

x

x

x

x

  

x

x

     

Blood glucose

Neonatal nurse

5 minutes

     

x1

x1

 

x

  

x

    

Blood pressure

Neonatal nurse

5 minutes

      

x

  

x

x

     

Maternal anxiety (STAI)

Study coordinator

15 minutes

            

x

x

 

x

Ages & Stages Questionnaire

Study coordinator

15 minutes

             

x

 

x

General movement (GMA)

Study coordinator

5 minutes

             

x

  

Bayley Scale of Infant and Toddler Development III

Occupational therapist

60 minutes

              

x

x

  1. X1 = the blood glucose is measured at either 90 or 120 minutes
  2. t0 = During stabilization
  3. t1 = After initial stabilization
  4. t2 = 15 minutes after birth
  5. t3 = 30 minutes after birth
  6. t4 = 60 minutes after birth
  7. t5 = 120 minutes after birth
  8. t6 = First 24 hour (hourly)
  9. t7 = Approximately 12 hours after birth
  10. t8 = 10 hours after birth
  11. t9 = 18 hours after birth
  12. t10 = Approximately 24 hours after birth
  13. t11 = At discharge
  14. t12 = 3 months corrected age
  15. t13 = 1 year corrected age
  16. t14 = 2 years corrected age
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Trials

ISSN: 1745-6215