In:
Archives of Disease in Childhood - Fetal and Neonatal Edition, BMJ, Vol. 105, No. 4 ( 2020-07), p. 369-374
Abstract:
Closed-loop automatic control (CLAC) of the fractional inspired oxygen (FiO 2 ) improved oxygen administration to preterm infants on respiratory support. We investigated whether a revised CLAC algorithm (CLAC fast , ≤2 FiO 2 adjustments/min), compared with routine manual control (RMC only ), increased the proportion of time with arterial haemoglobin oxygen saturation measured by pulse oximetry within prespecified target ranges (Target%) while not being inferior to the original algorithm (CLAC slow : ≤0.3 FiO 2 adjustments/min). Design Unblinded randomised controlled crossover study comparing three modes of FiO 2 control in random order for 8 hours each: RMC supported by CLAC fast was compared with RMC only and RMC supported by CLAC slow . A computer-generated list of random numbers using a block size of six was used for the allocation sequence. Setting Two German tertiary university neonatal intensive care units. Patients Of 23 randomised patients, 19 were analysed (mean±SD gestational age 27±2 weeks; age at randomisation 24±10 days) on non-invasive (n=18) or invasive (n=1) respiratory support at FiO 2 〉 0.21. Main outcome measure Target%. Results Mean±SD [95% CI] Target% was 68%±11% [65% to 71%] for CLAC fast versus 65%±11% [61% to 68%] for CLAC slow versus 58%±11% [55% to 62%] for RMC only . Prespecified hypothesis tests of: (A) superiority of CLAC fast versus RMC only and (B) non-inferiority of CLAC fast versus CLAC slow with margin of 5% yielded one-sided p values of 〈 0.001 for both comparisons. Conclusions This revised and faster CLAC algorithm was still superior to routine care in infants on respiratory support and not inferior to a previously tested slower algorithm. Trial registration number NCT03163108 .
Type of Medium:
Online Resource
ISSN:
1359-2998
,
1468-2052
DOI:
10.1136/archdischild-2019-317029
Language:
English
Publisher:
BMJ
Publication Date:
2020
detail.hit.zdb_id:
2188490-0
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