Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): an investigator-initiated, randomized, multi-center, multi-national, clinical trial on additional cerebral tissue oxygen saturation monitoring combined with defined treatment guidelines versus standard monitoring and treatment as usual in premature infants during immediate transition: study protocol for a randomized controlled trial.
Cerebral injury
Cerebral oxygenation
Immediate transition
Mortality
Neonate
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
20 Mar 2019
20 Mar 2019
Historique:
received:
16
02
2018
accepted:
27
02
2019
entrez:
22
3
2019
pubmed:
22
3
2019
medline:
6
8
2019
Statut:
epublish
Résumé
Transition immediately after birth is a complex physiological process. The neonate has to establish sufficient ventilation to ensure significant changes from intra-uterine to extra-uterine circulation. If hypoxia or bradycardia or both occur, as commonly happens during immediate transition in preterm neonates, cerebral hypoxia-ischemia may cause perinatal brain injury. The primary objective of the COSGOD phase III trial is to investigate whether it is possible to increase survival without cerebral injury in preterm neonates of less than 32 weeks of gestation by targeting cerebral tissue oxygen saturation (crSO COSGOD III is an investigator-initiated, randomized, multi-center, multi-national, phase III clinical trial. Inclusion criteria are neonates of less than 32 weeks of gestation, decision to provide full life support, and parental informed consent. Exclusion criteria are severe congenital malformations of brain, heart, lung, or prenatal cerebral injury or a combination of these. The premature infants will be randomly assigned to study or control groups. Both groups will have a near-infrared spectroscopy (NIRS) device (left frontal), pulse oximeter (right palm/wrist), and electrocardiogram placed immediately after birth. In the study group, the crSO crSO ClinicalTrials.gov Identifier: NCT03166722 . Registered March 5, 2017.
Sections du résumé
BACKGROUND
BACKGROUND
Transition immediately after birth is a complex physiological process. The neonate has to establish sufficient ventilation to ensure significant changes from intra-uterine to extra-uterine circulation. If hypoxia or bradycardia or both occur, as commonly happens during immediate transition in preterm neonates, cerebral hypoxia-ischemia may cause perinatal brain injury. The primary objective of the COSGOD phase III trial is to investigate whether it is possible to increase survival without cerebral injury in preterm neonates of less than 32 weeks of gestation by targeting cerebral tissue oxygen saturation (crSO
METHODS/DESIGN
METHODS
COSGOD III is an investigator-initiated, randomized, multi-center, multi-national, phase III clinical trial. Inclusion criteria are neonates of less than 32 weeks of gestation, decision to provide full life support, and parental informed consent. Exclusion criteria are severe congenital malformations of brain, heart, lung, or prenatal cerebral injury or a combination of these. The premature infants will be randomly assigned to study or control groups. Both groups will have a near-infrared spectroscopy (NIRS) device (left frontal), pulse oximeter (right palm/wrist), and electrocardiogram placed immediately after birth. In the study group, the crSO
DISCUSSION
CONCLUSIONS
crSO
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov Identifier: NCT03166722 . Registered March 5, 2017.
Identifiants
pubmed: 30894226
doi: 10.1186/s13063-019-3258-y
pii: 10.1186/s13063-019-3258-y
pmc: PMC6427901
doi:
Substances chimiques
Oxygen
S88TT14065
Banques de données
ClinicalTrials.gov
['NCT03166722']
Types de publication
Clinical Trial Protocol
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Langues
eng
Pagination
178Subventions
Organisme : Austrian Science Fund FWF
ID : KLI 615
Pays : Austria
Organisme : Fonds zur Förderung der wissenschaftlichen Forschung - FWF (AT)
ID : KlI 586-B31
Références
J Biomed Opt. 2000 Jul;5(3):283-6
pubmed: 10958613
Am J Obstet Gynecol. 1992 Dec;167(6):1916-7
pubmed: 1471722
Early Hum Dev. 2005 Sep;81(9):753-61
pubmed: 16107304
J Pediatr. 2006 May;148(5):585-9
pubmed: 16737865
J Pediatr. 2006 May;148(5):590-4
pubmed: 16737866
Arch Dis Child Fetal Neonatal Ed. 2007 Jan;92(1):F4-7
pubmed: 17185428
Pediatrics. 2008 Sep;122(3):e662-9
pubmed: 18762501
Pediatr Res. 2009 Apr;65(4):375-80
pubmed: 19127213
Semin Fetal Neonatal Med. 2010 Aug;15(4):203-7
pubmed: 20435536
Pediatrics. 2010 Jun;125(6):e1340-7
pubmed: 20439604
J Pediatr. 2011 Sep;159(3):404-8
pubmed: 21481417
Pediatr Res. 2011 Aug;70(2):176-80
pubmed: 21522035
Int J Dev Neurosci. 2011 Oct;29(6):551-63
pubmed: 21527338
J Perinatol. 2012 May;32(5):356-62
pubmed: 21852771
J Pediatr. 2012 Jun;160(6):943-8
pubmed: 22244465
Resuscitation. 2013 Jul;84(7):974-8
pubmed: 23313424
Neonatology. 2013;103(4):246-51
pubmed: 23428614
J Pediatr. 2013 Aug;163(2):394-9
pubmed: 23434123
Neonatology. 2013;103(4):259-63
pubmed: 23446114
Neuroradiology. 2013 Sep;55 Suppl 2:3-11
pubmed: 23955300
J Pediatr. 2013 Dec;163(6):1558-63
pubmed: 23972642
Neonatology. 2014;105(3):205-10
pubmed: 24481411
Neonatology. 2014;105(3):230-42
pubmed: 24504011
BMJ. 2015 Jan 05;350:g7635
pubmed: 25569128
Arch Dis Child Fetal Neonatal Ed. 2015 Sep;100(5):F422-7
pubmed: 26066762
Resuscitation. 2015 Oct;95:249-63
pubmed: 26477415
Resuscitation. 2015 Oct;95:e169-201
pubmed: 26477424
J Pediatr. 2016 Mar;170:73-8.e1-4
pubmed: 26743498
Front Pediatr. 2017 Feb 23;5:29
pubmed: 28280719
Pediatr Radiol. 2017 Aug;47(9):1031-1045
pubmed: 28779189
Arch Dis Child. 2018 Apr;103(4):363-370
pubmed: 29146572