Resuscitation of Asphyxiated Newborn Infants With Room Air or Oxygen: An International Controlled Trial: The Resair 2 Study

Abstract

Forms for 703 enrolled infants from 11 centers were received by the steering committee. All 94 patients from one of the centers were excluded because of violation of the inclusion criteria in 86 of these. Therefore, the final number of infants enrolled in the study was 609 (from 10 centers), with 288 in the room air group and 321 in the oxygen group. Median (5 to 95 percentile) gestational ages were 38 (32.0 to 42.0) and 38 (31.1 to 41.5) weeks (NS), and birth weights were 2600 (1320 to 4078) g and 2560 (1303 to 3900) g (NS) in the room air and oxygen groups, respectively. There were 46% girls in the room air and 41% in the oxygen group (NS). Mortality in the first 7 days of life was 12.2% and 15.0% in the room air and oxygen groups, respectively; adjusted odds ratio (OR) = 0.82 with 95% confidence intervals (CI) = 0.50-1.35. Neonatal mortality was 13.9% and 19.0%; adjusted OR = 0. 72 with 95% CI = 0.45-1.15. Death within 7 days of life and/or moderate or severe hypoxic-ischemic encephalopathy (primary outcome measure) was seen in 21.2% in the room air group and in 23.7% in the oxygen group; OR = 0.94 with 95% CI = 0.63-1.40. (ABSTRACT TRUNCATED)

No evidence for superiority of air or oxygen for neonatal resuscitation: a meta-analysis

“…The eight studies retained for analysis included 1,500 patients, 772 in the oxygen group and 728 in the air group. [4][5][6][7][8][9][10][11][12] The exact distribution per country cannot be given because 18 patients originally reported by Saugstad et al 8 were counted twice and need to be subtracted; nevertheless, as originally reported, the distribution would be: India = 1,148; Egypt = 121; Philippines = 26; Estonia = 26; Spain = 85; Denmark = 69; Norway = 2; United States = 41. The risk of bias assessment is given in Fig.…”

“…Four studies were quasi-randomized (allocation according to the date of birth [even vs odd]). 4,[6][7][8] One study mentioned that neonates for whom spontaneous circulation was never achieved were considered stillbirths and were excluded from the analysis. 8 For that study, deaths included in the analysis occurred only in non-European countries.…”

“…4,[6][7][8] One study mentioned that neonates for whom spontaneous circulation was never achieved were considered stillbirths and were excluded from the analysis. 8 For that study, deaths included in the analysis occurred only in non-European countries. 8 Of the four potentially randomized studies (three were said to be randomized, but the exact method was unspecified), three were not designed for clinical outcomes.…”

“…8 For that study, deaths included in the analysis occurred only in non-European countries. 8 Of the four potentially randomized studies (three were said to be randomized, but the exact method was unspecified), three were not designed for clinical outcomes. 5,9,10 In the study by Bajaj et al, 4 the neurological examination at discharge for the survivors in the room air group is missing for 15 patients, while all such data are given for the survivors in the oxygen group.…”

“…The number needed to harm (NNTH) is 20 (95% CI = 93 to 10), classical fail safe number is 2. Excluding the study where the number of true failed resuscitations (spontaneous circulation never achieved) was not counted, 8 the RR would be 1.35 (95% CI = 0.97 to 1.88; P = 0.08; I-squared 0%) (Fig. 3).…”