TABLE 1.
Study (Year) | Enrolled Patients, N | Protocol Specifications |
|||||
---|---|---|---|---|---|---|---|
Gestational Age, wk | Postnatal Age at Randomization | iNO Dose, ppm | Weaning Protocol, ppma | Planned Duration of Exposure | Gas Continued After Extubation? | ||
Subhedar et al28 (1997) | 42 | <32 | >96 h | 20→5b | — | 72 h | iNO not continued after extubation |
Kinsella et al25 (1999) | 80 | <34 | <7 d | 5b | — | 7–14 d | iNO not continued after extubation |
Srisuparp et al27 (2002) | 34 | <32 | <72 h | 20→0b | — | 72 h to 7 d | iNO not continued after extubation |
Schreiber et al26 (2003) | 207 | <34 | <72 h | 10→5a | 10 (1 d), 5 (6 d) | 7 d | In infants who were extubated within 7 d, gas was stopped 1 h before extubation |
Field et al (INNOVO)23 (2005) | 126 | <34 | <28 d | 5→40b | — | 48 h to 3 d | iNO stopped before extubation |
Van Meurs et al29,30 (2005 and 2007) | 449 | <34 | >4 h | 5→10b | — | <14 d | iNO not continued after extubation |
Hascoet et al22 (2005) | 145 | <32 | 6–48 h | 5→10b | — | Up to the time when a/Ao2 increases to >0.22 (median: 28 h) | iNO not continued after extubation |
Dani et al21 (2006) | 40 | <30 | <7 d | 10→6a | 10 (4 h), 6 (until extubation) | 81 h | iNO not continued after extubation |
Kinsella et al24 (2006) | 793 | <34 | <48 h | 5a | No change | 21 d | iNO stopped before extubation |
Ballard et al19 (2006) | 582 | <32 | 7–21 d | 20→2a | 20 (48–96 h), 10, 5, 2 at weekly intervals | 24 d minimum | iNO continued after extubation and after discontinuation of nasal CPAP ± oxygen |
Mercier et al (EUNO)31 (2010) | 800 | <29 | <72 h | 5a | No change | 7–21 d | iNO continued for 7 d or until extubation, whichever came later |
Total | 3298 | — | — | — | — | — | — |
a-Ao2 indicates alveolar-arterial oxygen gradient; CPAP, continuous positive airway pressure.
No dose change or change based on prespecified weaning protocol with fixed time points.
Dose changes based on measured biological response in patient.