Evidence Table 9Other short term outcomes addressing KQ2 including PDA, sepsis, NEC, ROP, Pulmonary outcomes, and methemoglobinemia

Author, YearOutcomesTime of outcome measureArm DescriptionN (number of participants measured)Participants with outcome—n (%)Relative Effect (95% CI)Adjusted Relative Effect (95% CI)Adjustments
Ballard, 20061Cardiac Outcomes, PDA Requiring Medical or Surgical Treatmentafter study entryControl28855 (19.1)P-value: 0.85
RR: 0.96 (0.68-1.35)
iNO29454 (18.4)
Field, 20052during hospitalizationControl5313 (25)
iNO559 (16)
Schreiber, 20033Before dischargeControl10226 (25.5)P-value: 0.27
RR: 0.75 (0.45-1.25)
iNO10520 (19)
Kinsella, 20064Cardiac Outcomes, PDA Requiring Medical TreatmentBefore dischargeControl395212 (53.7)P-value: 0.92study sight, randomization strata
iNO398215 (54)
Srisuparp, 20025Before dischargeControl181 (5.6)P-value: 1
iNO160 (0)
Su, 20086Before dischargeControl338 (24.2)
iNO329 (28.1)
Subhedar, 19977Before dischargeControl dexamethasone and standard of care221 (5)
Groups 1&3; iNO + iNO and dexamethasone203 (15)
Dexamethasone alone AND dex + iNO211 (5)
iNO AND standard of care212 (10)
Kinsella, 20064Cardiac Outcomes, PDA requiring surgical treatmentBefore dischargeControl39586 (21.8)P-value: 0.96study sight, randomization strata
iNO39886 (21.6)
Mercier, 2010824-28 weeksControl39745 (11.3)
iNO39559 (14.9)
Srisuparp, 20025Before dischargeControl180 (0)P-value: 0.47
iNO161 (6.3)
Subhedar, 19977Before dischargeControl dexamethasone and standard of care222 (10)
Groups 1&3; iNO + iNO and dexamethasone201 (5)
Dexamethasone alone AND dex + iNO212 (10)
iNO AND standard of care212 (10)
Dani, 20069Cardiac Outcomes, Incidence of PDABefore dischargeControl2018 (90)P-value: 0.421
iNO2016 (80)
Nonresponders65 (60)P-value: 0.657
Responders1411 (80)
Kinsella, 199910Cardiac Outcomes, Symptomatic PDABefore dischargeControlUnclearUnclear (19)P-value: NS
iNOUnclear (21)
Subhedar, 19977Before dischargeControl dexamethasone and standard of care223 (15)
Groups 1&3; iNO + iNO and dexamethasone204 (20)
Dexamethasone alone AND dex + iNO213 (14)
iNO AND standard of care214 (19)
Hascoet, 200511Cardiac Outcomes, Undefined PDA28 daysControl with Hypoxemic Respiratory Failure8431 (37)P-value: NS
iNO with Hypoxemic Respiratory Failure6120.74 (34)
Dani, 20069Sepsis Defined by Positive Culturebefore dischargeControl2010 (50)
iNO208 (40)0.751
Responders62 (33)
Nonresponders146 (43)0.545
Field, 20052during hospitalizationControl5321 (40)
iNO5523 (42)
Srisuparp, 20025UnspecifiedControl187 (38.9)1
iNO167 (43.8)1
Field, 20052Sepsis Defined by Clinicianduring hospitalizationControl53
iNO5512 (22)
Su, 2008 {#200)Undefined SepsisUnspecifiedControl332 (6.1)
iNO323 (9.4)
Kinsella, 20064UnspecifiedControl369118 (32)
iNO381139 (0.365)0.19randomization strata, study sight
Ballard, 20061after study entryControl288118 (41)0.91
0.98(0.80-1.20)
iNO294121 (41.2)0.91
0.98(0.80-1.20)
Schreiber, 20033After 24 hours of ageControl10250 (49)
iNO10554 (51.5)0.73
1.05 (0.80-1.38)
Ballard, 20061Cardiac Outcomes, NEC requiring surgical treatmentafter study entryControl28819 (6.6)P-value: 0.63
RR: 1.17(0.64-2.13)
iNO29423 (7.8)
Ballard, 20061Cardiac Outcomes, NEC requiring medical treatmentafter study entryControl2888 (2.8)P-value: 0.84
RR:1.20(0.46-3.13)
iNO29410 (3.4)
Dani, 20069Cardiac Outcomes, NEC diagnosed by clinical criteriaBefore dischargeControl200 (0)P-value: 0.5
iNO201 (5)
Before dischargeNonresponders60 (0)P-value: 0.7
Responders141 (7)
Hascoet, 200511Cardiac Outcomes, NEC undefined28 days of lifeControl with Hypoxemic Respiratory Failure84(6)NS
iNO with Hypoxemic Respiratory Failure61(8)
Kinsella, 20064Before dischargeControl36946 (12.5)0.54study site, randomization strata
iNO37953 (14)
Mercier, 20108Before dischargeControl3977 (1.8)
iNO39511 (2.8)
Schreiber, 20033before dischargeControl1026 (5.9)P-value: 0.11
RR: 2.10 (0.83-5.32)
iNO10513 (12.4)
Su, 20086Before dischargeControl332 (6.1)
iNO322 (6.3)
Subhedar, 19977before dischargeControl dexamethasone and standard of care222 (10)
Groups 1&3; iNO + iNO and dexamethasone201 (5)
Dexamethasone alone AND dex + iNO212 (10)
iNO AND standard of care211 (5)
Ballard, 20061ROP requiring treatment by cryo or laserAfter study entryControl28868 (23.6)p-value: 0.95
RR = 0.97 (0.72-1.31)
iNO29472 (24.5)
Field, 20052Before hospital dischargeControl494 (8)
iNO508 (16)
Kinsella, 199910Before hospital dischargeControl153 (20)P-value: 0.1
iNO251 (4)
Kinsella, 20064Before DischargeControl39560 (15.2)P-value: 0.59
iNO39866 (16.6)
Schreiber, 20033Before hospital dischargeControl10210 (9.8)P-value: 0.27
iNO1056 (5.7)
Subhedar, 19977Before Hospital DischargeControl dexamethasone and standard of care220 (0)
Groups 1&3; iNO + iNO and dexamethasone202 (10)
Dexamethasone alone AND dex + iNO212 (10)
iNO AND standard of care210 (0)
Van Meurs, 200712Before DischargeControl52 (40)P-value: 0.44
iNO50 (0)
Van Meurs, 200513before hospital dischargeControl11236 (32)P-value: 0.42Study center, Oxygenation index, birth weight
iNO9829 (30)
Field, 20052Pulmonary HemorrhageHospital dischargeControl535 (9)
iNO554 (7)
Kinsella, 20064Before dischargeControl39526 (6.6)0.75study sight, randomization strata
iNO39824 (6)
Mercier, 20108DischargeControl39714 (3.5)
iNO39512 (3)
Schreiber, 20033Before dischargeControl1024 (3.8)P-value: 0.37
RR:0.56 (0.17-1.84)
iNO1057 (6.9)
Su, 20086Before dischargeControl332 (6.1)
iNO323 (9.4)
Field, 20052Air LeakHospital dischargeControl5320 (38)
iNO5520 (36)
Kinsella, 199910
Kinsella, 20064Before dischargeControl39524 (6.1)P-value: 0.94study sight, randomization strata
iNO, Total sample)39825 (6.3)
Mercier, 2010824-28 weeksControl39713(3)
iNO39512 (2)
Schreiber, 20033Before dischargeControl10216 (15.7)P-value: 0.27
RR: 0.67 (0.33-1.37)
iNO10511 (10.5)
Before dischargeControl102Pulmonary interstitial emphysema 35 (34.3)P-value: 0.23
RR: 0.78 (0.51-1.18)
iNO105Pulmonary interstitial emphysema 28 (26.7)
Srisuparp, 2002572 hoursControl181 (5.6)p-value: 0.59
iNO162 (12.5)
Su, 20086Before dischargeControl332 (6.1)
iNO322 (6.3)
Subhedar, 19977Before dischargeControl dexamethasone and standard of care221 (5)
Groups 1&3; iNO + iNO and dexamethasone203 (15)
Dexamethasone alone AND dex + iNO213 (14)
iNO AND standard of care211 (5)
Van Meurs, 200513Before dischargeControl11737 (32)P-value: 0.55
RR: 1.12 (0.78-1.61)
center, Oxygenation index, birth weight
iNO10135 (35)
Van Meurs, 200712dischargeControl112 (18)P-value:0.48
iNO90 (0)
Schreiber, 20033Cardiac Outcomes, Methemoglobi nemia >4%Before dischargeControl1020 (0)
iNO1053 (2.9)
Van Meurs, 200712Before dischargeControl140 (0)
iNO140 (0)
Van Meurs, 200513Before dischargeControl2102 (1)center, Oxygenation index
iNO2102 (1)
Schreiber, 20033Cardiac Outcomes, Methemoglobi nemia >8%Before dischargeControl1020 (0)
iNO1050 (0)
Van Meurs, 200513Before dischargeControl2100 (0)P-value: 0.99center, Oxygenation index

CI: Confidence Interval; HRF: Hypoxemic respiratory failure; iNO: Inhaled nitric oxide; NEC: Necrotizing enterocolitis; NS: Not significant,: Relative risk; PDA: Patent Ductus Arteriosis; ROP: Retinopathy of Prematurity; RR: Relative risk;

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.

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