Evidence Table 14NDI and death or NDI outcomes for KQ3

Author, yearOutcomeTime of Outcome MeasureStudy ArmN (Participants Measured)Number of Participants with Outcome—n (%)Relative Effect (95% CI)Adjusted Relative Effect (95% CI)Adjustments
Bennett, 20011Severe neurodisability - one or more of: moderate or severe developmental delay; CP; sensorineural impairment (hearing loss requiring hearing aids and blindness)30 months corrected ageControl145 (36)P-value: 0.12
iNO70 (0)
Hintz SR, 20072NDI: any of the following: mod-severe CP, blind, deaf, MDI<70 or PDI<7018-22 monthsControl10248(47)P-value:0.74
RR: 1.07 (0.80 - 1.44)
Model #1: BWt,center, OI entry <criterion strata, sex, Model #2: same as model #1 + BPD, IVH gr 3 or 4 or PVL, length of iNO exposure, postnatal steroids
iNO8945 (51)
Isolated delay = MDI<70 or PDI<70 n absence of mod-severe CP, deafness or blindnessControl10235 (34)P-value:0.37
RR:0.79 (0.51-1.23)
P-value: Model #1: 0.78:
Model #2 0.37
RR: Model #1: 1.04 (0.79-1.36);
Model #2: 1.19 (0.81-1.73)
Model #1: BWt, center, OI entry criterion strata, sex
iNO8824 (27)
Unimpaired = MDI & PDI>85, no mod-severe CP, and not blind or deafControl10226 (25)P-value:0.86
RR:0.92 (0.56-1.51)
P-value: Model #1: 0.10;
Model #2 0.43
RR: Model #1: 0.72 (0.48-1.07);
Model #2: 0.79 (0.44-1.42)
Model #1: BWt, center, OI entry criterion strata, sex
Huddy, 20083Overall outcome: severe disability4-5 yrs, median 4.52 (IQR 0.9)Control163 (18.7)
4-5 yrs, median 4.63, IQR 0.84)iNO223 (13.6)
Overall outcome: Moderate disability4-5 yrs, median 4.52 (IQR 0.9)Control164 (25)
4-5 yrs, median 4.63, IQR 0.84)iNO225 (22.7)
Overall outcome: Normal4-5 yrs, median 4.52 (IQR 0.9)Control163 (18.7)
4-5 yrs, median 4.63, IQR 0.84)iNO225 (22.7)
Overall outcome: mild disability4-5 yrs, median 4.52 (IQR 0.9)Control164 (25)
4-5 yrs, median 4.63, IQR 0.84)iNO226 (27.3)
Mestan, 20054Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected age 24.9 +/-7.9 months corrected ageControl6831 (46)P-value:0.01
RR: 0.53 (0.33-0.87)
P-value: Model #1: 0.50:
Model #2 0.79
RR: Model #1: 0.85 (0.54-1.35);
Model #2: 0.91 (0.46-1.81))
iNO7017 (24)
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68birth weight
24.9 +/-7.9 months corrected ageiNO70
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68P-value:0.002
RR:0.57(0.35-0.93
sex
24.9 +/-7.9 months corrected ageiNO70
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68P-value:0.006
RR:0.52 (0.32-0.82)
Mother graduation from high school
24.9 +/-7.9 months corrected ageiNO70
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68P-value:0.007
RR:0.48 (0.28-0.82)
household without employed person
24.9 +/-7.9 months corrected ageiNO70
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68P-value:0.006
RR:0.49 (0.29-0.82)
type of ventilation
24.9 +/-7.9 months corrected ageiNO70
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68P-value:0.01
RR:0.53 (0.33-0.87)
chronic lung disease and severe IVH or PVL
24.9 +/-7.9 months corrected ageiNO70
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68P-value:0.03
RR:0.6 (0.38-0.96)
prolonged postnatal exposure to corticosteroids
24.9 +/-7.9 months corrected ageiNO70
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68P-value:0.01
RR:0.53 (0.33-0.87)
birth weight and sex
24.9 +/-7.9 months corrected ageiNO70
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68P-value:0.01
RR:0.55 (0.35-0.99)
severe intraventricular hemorrhage or periventricular leukomalacia
24.9 +/-7.9 months corrected ageiNO70
Abnormal neurodevelopmental outcome (any disability or any BSID II score <70)25.2+/-8.4 months corrected ageControl68P-value:0.01
RR:0.55 (0.34-0.89)
chronic lung disease
24.9 +/-7.9 months corrected ageiNO70
Van Meurs, 20075NDI = any one of the following: moderate to severe CP, blind, deaf, MDI <70, or PDI <7018 to 22 monthsControl82 (25)P-value:0.58
RR: 0.44 (0.05-4.02)
OI stratum
iNO91 (11)
Walsh, 20106NDI in subset with complete evaluations2 yearsControl212(51)RR:0.93 (0.76-1.14)
24.9 +/-7.9 months corrected ageiNO207(48)
Neuro development al Impairment (NDI = MDI<70, PDI<70, unable to crawl or walk (GMFCS>=2), bilateral blindness, or bilateral deafness requiring amplification).2 yearsControl234114 (49)RR: 0.92 (0.75-1.12)
iNO243109 (44.8)
Watson, 20097NDI (CP, severe hearing loss, MDI or PDI< 70,or blindness)1 year corrected ageControl21873 (33.5)P-value: 0.66
iNO23784 (35.4)
Van Meurs, 20075Death or NDI, Death and/or NDI18 to 22 monthsControl126 (50)P-value: 1
RR: 0.86 (0.37-1.96)
P-value: 0.8
RR: 0.90 (0.40-2.02)
OI Strata
iNO146 (43)
Van Meurs, 20075Death or NDI, Death and/or moderate to severe CP18 to 22 monthsControl124 (33)P-value: 1
RR: 1.07 (0.37-3.11)
P-value: 0.88
RR: 1.08 (0.39-3.03)
OI Strata
iNO145 (36)
Bennett, 20011Death or NDI, Death or severe neurodisability30 months corrected ageControl2213 (59)P-value: 0.79
RR: 1.1 (0.57-2.3)
iNO1912 (63)
Watson, 20097Death or NDI, Death or NDI (CP, severe hearing loss, MDI or PDI< 70,or blindness)1 year corrected ageControl384171 (44.5)P-value: 0.55
iNO387164 (42.4)
Watson, 20097Death or NDI, Death, on oxygen, or NDI (CP, severe hearing loss, MDI or PDI< 70,or blindness)1 year corrected ageControl384175 (45.6)P-value: 0.65
iNO387170 (43.9)
Hintz SR, 20072Death or NDI, Death or NDI:any of the following: mod-severe CP, blind, deaf, MDI<70 or PDI<7018-22 monthsControl200146 (73)P-value: 0.32
RR:1.07 (0.95-1.19)
P-value: 0.3
RR: Model #1:1.06 (0.95-1.17)
Model #1: BWt, center, OI entry criterion strata, sex
iNO198154 (78)
Hintz SR, 20072Death or NDI, Death or moderate to severe CP18-22 monthsControl200109 (54)P-value: 0.07
RR: 1.17 (0.99-1.38)
P-value: 0.07
RR: Model #1: 1.15 (0.99-1.34)
Model #1: BWt, center, OI entry criterion strata, sex
iNO199127 (64)

CI: Confidence Interval; CP: Cerebral Palsy; GMFCS: Gross motor function classification system; iNO: Inhaled nitric oxide; IQR: Inter-quartile range; MDI: Mental developmental index; NDI: Neurodevelopmental impairment; NS: Not significant,OI: Oxygenation index; OI: Oxygenation Index; PDI: Physical developmental index;

From: Appendix E, Evidence Tables

Cover of Inhaled Nitric Oxide in Preterm Infants
Inhaled Nitric Oxide in Preterm Infants.
Evidence Reports/Technology Assessments, No. 195.
Allen MC, Donohue P, Gilmore M, et al.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.