Detailed statistical analysis plan for the Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) randomised clinical trial on sildenafil versus placebo for pregnant women with severe early onset fetal growth restriction

Table 6 Two-year neurodevelopmental outcomes

	Intention to treat			Intention to treat, adjusted for GA and EFW at inclusion			Per protocol
	Sildenafil (n =)	Placebo (n =)	P value	Sildenafil (n =)	Placebo (n =)	P value	Sildenafil (n =)	Placebo (n =)	P value
Cognitive composite score (mean)
Motor score (mean)
Fine motor score (mean)
Gross motor score (mean)
Bayley III cognitive composite score and motor score
< 70
70–84
85–99
≥ 100
Bayley III motor composite score and motor score
< 70
70–84
85–99
≥ 100
Cerebral palsy, all*
GMFCS grade 1
GMFCS grade 2
GMFCS grade 3
GMFCS grade 4
GMFCS grade 5
Normal vision
Impaired vision despite glasses or lenses
Mildly abnormal vision despite glasses or lenses
No useful vision
Strabismus or amblyopia with normal (corrected) vision
Normal hearing
Subnormal hearing for those cases that do need aids and have mild hearing loss at time of testing at age 2 years (i.e. mostly conductive in origin)
Hearing loss (partly) corrected with aids
Hearing loss not corrected with aids
Normal communication
No normal communication
Growth
height mean z-score, corrected age
Weight mean z-score corrected age BMI z-score corrected age
Head circumference mean z-score corrected age
Neurodevelopmental impairment I and II**

GA gestational age, EFW estimated fetal weight, GMFCS Gross Motor Function Classification System
*We will score all cerebral palsy (CP) cases and then subdivide them in GMFCS levels; a child that does not have CP will not have a GMFCS score
**Defined as either a cognitive Bayley III score < 85 or estimated cognitive delay > 3 months, cerebral palsy, with a GMFCS > 1, hearing loss needing hearing aids, or severe visual loss (legally certifiable as blind or partially sighted)

ISSN: 1745-6215