Table 1.
Time point | Study Period | ||||||||
---|---|---|---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | |||||||
-t 1 | t 1 | t 2 | t 3 | t 4 | t 5 | t 6 | t 7 | ||
Enrolment: | |||||||||
Eligibility screen | X | ||||||||
Informed consent | X | ||||||||
Randomization and allocation | X | ||||||||
Interventions: | |||||||||
SSC group | X | ||||||||
TC group | X | ||||||||
Assessments: | |||||||||
State-Trait Anxiety Inventory, STAI | X | X | |||||||
Salivary cortisol | X | ||||||||
Brazelton Neonatal Assessment Scale, BNAS | X | ||||||||
Neuroimaging | X | ||||||||
Infant Neurological International Battery, INFANIB | X | ||||||||
Paternal Postnatal Attachment Scale, PPAS | X | X |
t1 = During hospitalization
t2 = 1 day to 3 days after birth
t3 = 10-15 days after birth
t4 = 37 weeks of corrected age or before discharge
t5 = 38-42 weeks of corrected age
t6 = 4 months after discharge
t7 = 6 months after discharge