Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial

Hansen, Mathias; Pellicer, Adelina; Gluud, Christian; Dempsey, Eugene; Mintzer, Jonathan; Hyttel-Sorensen, Simon; Heuchan, Anne; Hagmann, Cornelia; Ergenekon, NURİYE; Dimitriou, Gabriel; Pichler, Gerhard; Naulaers, Gunnar; Cheng, Guoqiang; Guimaraes, Hercilia; Tkaczyk, Jakub; Kreutzer, Karen; Fumagalli, Monica; Claris, Olivier; Lemmers, Petra; Fredly, Siv; Szczapa, Tomasz; Austin, Topun; Jakobsen, Janus; Greisen, Gorm

doi:10.1186/s13063-019-3955-6

Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial

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Hansen M. L., Pellicer A., Gluud C., Dempsey E., Mintzer J., Hyttel-Sorensen S., ...More

TRIALS, vol.20, no.1, 2019 (SCI-Expanded)

Publication Type: Article / Article
Volume: 20 Issue: 1
Publication Date: 2019
Doi Number: 10.1186/s13063-019-3955-6
Journal Name: TRIALS
Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
Keywords: Randomised clinical trial, Preterm, Near infrared spectroscopy, Protocol, OBSERVER BIAS, OUTCOMES, INJURY, INTERVENTIONS, STANDARD
Gazi University Affiliated: Yes

Abstract

Background: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.