Table 4:
Neurodevelopment Outcomes Among Follow-up Completers
| Study Group | |||||
|---|---|---|---|---|---|
| Outcome | Inositol Follow-up Completers (N=242) | Placebo Follow-up Completers (N=264) | Adjusted Risk Diff (95% CI) | Adjusted RR (95% CI) | P-value |
| Growth at Follow-up | |||||
| Weight - kg, mean (std)1 | 11.8 (2.2) | 11.7 (1.7) | 0.01 (−.32 to 0.34) | 0.94 | |
| Head Circumference - cm, mean (std)1 | 47.5 (2.3) | 47.6 (2.4) | −.12 (−.49 to 0.24) | 0.50 | |
| Height - cm, mean (std)1 | 85.3 (4.1) | 85.6 (4.3) | −.41 (−1.1 to 0.31) | 0.26 | |
| Components of NDI | |||||
| Cerebral Palsy, Any2 | 39/240 (16%) | 39/259 (15%) | 1 (−5 to 7) | 1.08 (0.72 to 1.62) | 0.71 |
| Cerebral Palsy, moderate or severe2 | 22/239 (9%) | 16/258 (6%) | 2 (−2 to 7) | 1.49 (0.80 to 2.76) | 0.21 |
| GMFCS >=22 | 25/238 (11%) | 24/258 (9%) | 1 (−4 to 6) | 1.12 (0.66 to 1.90) | 0.67 |
| BSID III Cognitive <702 | 31/231 (13%) | 38/258 (15%) | −1 (−7 to 5) | 0.91 (0.59 to 1.41) | 0.66 |
| BSID III Cognitive <851 | 78/231 (34%) | 83/258 (32%) | 2 (−6 to 10) | 1.05 (0.82 to 1.34) | 0.72 |
| BSID III Motor <702 | 37/227 (16%) | 34/253 (13%) | 3 (−3 to 9) | 1.20 (0.78 to 1.85) | 0.40 |
| BSID III Motor <851 | 94/227 (41%) | 107/253 (42%) | −1 (−10 to 7) | 0.99 (0.81 to 1.22) | 0.94 |
| Bilateral Blindness3 | 3/240 (1%) | 4/259 (2%) | 0 (−2 to 2) | 0.81 (0.18 to 3.58) | 0.78 |
| Unilateral Blindness3,4 | 4/240 (2%) | 5/259 (2%) | 0 (−3 to 2) | 0.86 (0.23 to 3.18) | 0.83 |
| Bilateral Hearing Loss2 | 11/238 (5%) | 6/252 (2%) | 3 (−3 to 9) | 1.93 (0.73 to 5.10) | 0.19 |
| Ophthalmologic Outcomes | |||||
| Any ROP through follow-up2,5 | 171/242 (71%) | 185/264 (70%) | 0 (−7 to 8) | 1.02 (0.92 to 1.13) | 0.75 |
| Any Ophthalmologic treatment1,6 | 42/195 (22%) | 37/221 (17%) | 4 (−3 to 12) | 1.30 (0.87 to 1.92) | 0.20 |
| Any Ophthalmologic surgery1,7 | 15/195 (8%) | 13/221 (6%) | 0 (−5 to 5) | 1.32 (0.64 to 2.70) | 0.45 |
| Strabismus1,8 | 35/239 (15%) | 39/263 (15%) | −1 (−7 to 5) | 0.98 (0.66 to 1.47) | 0.93 |
| Nystagmus2,9 | 11/239 (5%) | 8/263 (3%) | 1 (−2 to 5) | 1.51 (0.62 to 3.70) | 0.36 |
NDI, neurodevelopmental impairment; GMFCS, gross motor function classification system; BSID III, Bayley Scales of Infant Development-III; ROP, retinopathy of prematurity
Analyses adjusted for center and gestational age strata
Analyses adjusted for gestational age strata
Analyses not adjusted due to low cell count
Includes bilateral blindness
Includes 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
Includes any reported eye surgery or medical treatment (in either eye) on the INS 3–14 Follow-up form
Includes any reported eye surgery (in either eye) on the INS 3–14 Follow-up form
Includes any report of Strabismus in the Follow-up NF-04 or NF-05 forms
Includes any report of Nystagmus in the Follow-up NF-04 or NF-05 forms