Table 2 Flow diagram according to SPIRIT recommendations (Standard Protocol Items: Recommendations for Interventional Trials)

Infant characteristic

 Eligibility screening

x

 Allocation and randomization

x

 Length, weight, head circumference

x

x

x

x

x

x

x

 Gestational age

x

 Apgar score

x

 Birth measurements

x

CP risk factors

 Familial disposition CP

x

 Imaging with CT / MRI^a

x

 Co-morbidities

x

x

x

x

x

x

x

 Medication

x

x

x

x

x

x

x

 Genomic testing

x

Outcome measures

 HINE [8]

x

x

x

x

x

x

 GMA (if below 5 months) at age 12–15 and 16 weeks [7]

x

 PDMS-2 [25]

x

x

x

x

x

 AIMS [26]

x

x

x

x

x

 HAI (if below 12 months) [9]^b

x

x

x

x

x

 GMFM-66 [27]

x

x

x

 BSID-IV-cog [28]

x

x

x

 COPM by interview in intervention group [29]

x

x

 PSS questionnaire [30]

x

x

x

x

x

 DASS-21 questionnaire [31]

x

x

x

x

x

 MPOC-SP&20 questionnaire [27]^c

x

x

 ASQ questionnaire [32]

x

 Clinical assessment of CP diagnosis

x

x

x

x

x

 GMFCS if CP

x

x

x

x

 Mini-MACS if CP

x

Intervention

 GO-PLAY intervention

x

x