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

Atıf İçin Kopyala

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

TRIALS, cilt.20, sa.1, 2019 (SCI-Expanded)

Yayın Türü: Makale / Tam Makale
Cilt numarası: 20 Sayı: 1
Basım Tarihi: 2019
Doi Numarası: 10.1186/s13063-019-3955-6
Dergi Adı: TRIALS
Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
Anahtar Kelimeler: Randomised clinical trial, Preterm, Near infrared spectroscopy, Protocol, OBSERVER BIAS, OUTCOMES, INJURY, INTERVENTIONS, STANDARD
Gazi Üniversitesi Adresli: Evet

Özet

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.