Table 3:

Composite Outcome Of Death Or Survival With Moderate/Severe Neurodevelopmental Impairment Among Randomized Infants¹

	Study Group
Outcome	Inositol (N=302)	Placebo (N=303)	Adjusted Risk Diff (95% CI)	Adjusted RR (95% CI)	P-value
Corrected age at follow-up; Median (IQR)	24 (23,26)	24 (22,26)	N/A	N/A
NDI or Death Prior to Follow-up	172/287 (60%)	161/289 (56%)	2 (−5 to 10)	1.06 (0.93 to 1.21)	0.40
Any ROP or Death Prior to Follow-up	231/302 (76%)	224/303 (74%)	1 (−6 to 7)	1.03 (0.94 to 1.12)	0.53
Death Prior to Follow-up	60/302 (20%)	39/303 (13%)	4 (−2 to 11)	1.53 (1.08 to 2.18)	0.02
Moderate or Severe NDI	112/227 (49%)	122/250 (49%)	−1 (−9 to 8)	1.01 (0.85 to 1.21)	0.88
Moderate NDI2	66/227 (29%)	79/250 (32%)
Severe NDI3	46/224 (21%)	43/246 (17%)
Any ROP4	181/260 (70%)	191/271 (70%)	−2 (−10 to 5)	0.99 (0.90 to 1.10)	0.92

NDI, neurodevelopmental impairment; ROP, retinopathy of prematurity

All analyses adjusted for center and gestational age strata

¹Excludes lost to follow-up participants

²Occurrence of any of the following: GMFCS level II or III, Bayley III cognitive composite score between and including 70 and 84, Bayley III motor composite score between and including 70 and 84, unilateral blind or bilateral blind, permanent hearing loss that does not permit child to understand directions of the examiner and communicate despite amplification with cochlear implant or hearing aid

³Occurrence of any of the following: GMFCS level IV or V, Bayley III cognitive composite score < 70, Bayley III motor composite score < 70, unilateral blind or bilateral blind, permanent hearing loss that does not permit child to understand directions of the examiner and communicate despite amplification with cochlear implant or hearing aid

⁴Includes any report of ROP in the GDB NG-03 form, Follow-up NF-04 form, INS 3–14 Follow-up form (ophthalmologist diagnosed or treated ROP), or a documented finding of ROP on any ophthalmologic exam during the initial INS follow-up