The SafeBoosC phase II randomised clinical trial: a treatment guideline for targeted near-infrared-derived cerebral tissue oxygenation versus standard treatment in extremely preterm infants.
Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rStO2) reflects venous oxygen saturation. If cerebral metabolism is stable, rStO2 can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rStO2 and a treatment guideline to correct deviations in rStO2 outside a predefined target range.


OBJECTIVE
To describe the rationale for and content of this treatment guideline.


METHODS
Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions.


CONCLUSIONS
A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated. The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II randomised clinical trial. The evidence grades were relatively low and the guideline cannot be recommended outside a research setting.
Department of Neonatology, La Paz University Hospital, Madrid, Spain.
Adelina
A
Pellicer
Gorm
G
Greisen
Manon
M
Benders
Olivier
O
Claris
Eugene
E
Dempsey
Monica
M
Fumagalli
Christian
C
Gluud
Cornelia
C
Hagmann
Lena
L
Hellström-Westas
Simon
S
Hyttel-Sorensen
Petra
P
Lemmers
Gunnar
G
Naulaers
Gerhard
G
Pichler
Claudia
C
Roll
Frank
F
van Bel
Wim
W
van Oeveren
Maria
M
Skoog
Martin
M
Wolf
Topun
T
Austin
D000465:Algorithms; D001921:Brain / Q000502:physiology*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods / Q000592:standards; D006801:Humans; D062071:Infant, Extremely Premature / Q000502:physiology*; D007231:Infant, Newborn; D010092:Oximetry / Q000379:methods*; D010100:Oxygen / Q000008:administration & dosage / Q000502:physiology*; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D019265:Spectroscopy, Near-Infrared / Q000592:standards*
D010100:Oxygen