Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants.

Mathias Lühr HansenAdelina PellicerChristian GluudEugene DempseyJonathan MintzerSimon Hyttel-SorensenAnne Marie HeuchanCornelia HagmannGabriel DimitriouGerhard PichlerGunnar NaulaersGuoqiang ChengAna VilanJakub TkaczykKaren B KreutzerMonica FumagalliOlivier ClarisSiv FredlyTomasz SzczapaTheis LangeJanus Christian JakobsenGorm Greisen

Published in: Trials (2019)

ClinicalTrials.org, NCT03770741. Registered on 10 December 2018.

Keyphrases

clinical trial
preterm infants
study protocol
open label
phase ii
phase iii
double blind
subarachnoid hemorrhage
low birth weight
brain injury
combination therapy
smoking cessation