Idioma:

Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial

Hyttel-Sorensen, Simon ; Pellicer, Adelina ; Alderliesten, Thomas ; Austin, Topun ; van Bel, Frank ; Benders, Manon ; Claris, Olivier ; Dempsey, Eugene ; Franz, Axel R ; Fumagalli, Monica ; Gluud, Christian ; Grevstad, Berit ; Hagmann, Cornelia ; Lemmers, Petra ; van Oeveren, Wim ; Pichler, Gerhard ; Plomgaard, Anne Mette ; Riera, Joan ; Sanchez, Laura ; Winkel, Per ; Wolf, Martin ; Greisen, Gorm

BMJ (Online), 2015-01, Vol.350 (jan05 2), p.g7635-g7635 [Periódico revisado por pares]

England: British Medical Journal Publishing Group

Texto completo disponível

Citações Citado por

Enviar para

Título:
Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial
Autor: Hyttel-Sorensen, Simon ; Pellicer, Adelina ; Alderliesten, Thomas ; Austin, Topun ; van Bel, Frank ; Benders, Manon ; Claris, Olivier ; Dempsey, Eugene ; Franz, Axel R ; Fumagalli, Monica ; Gluud, Christian ; Grevstad, Berit ; Hagmann, Cornelia ; Lemmers, Petra ; van Oeveren, Wim ; Pichler, Gerhard ; Plomgaard, Anne Mette ; Riera, Joan ; Sanchez, Laura ; Winkel, Per ; Wolf, Martin ; Greisen, Gorm
Assuntos: Blood pressure ; Brain - blood supply ; Brain research ; Cerebrovascular Circulation ; Children & youth ; Clinical Protocols ; Clinical trials ; Europe ; Gestational age ; Guideline Adherence ; Hemoglobin ; Humans ; Hyperoxia ; Hypoxia ; Hypoxia - diagnosis ; Hypoxia - pathology ; Infant, Extremely Premature ; Infant, Newborn ; Intensive Care Units, Neonatal ; Intensive Care, Neonatal ; Intervention ; Medical equipment ; Monitoring, Physiologic - methods ; Multiple births ; Newborn babies ; Oximetry - methods ; Practice Guidelines as Topic ; Premature babies ; Sensors ; Spectroscopy, Near-Infrared - methods ; Spectrum analysis ; Time Factors ; Treatment Outcome
É parte de: BMJ (Online), 2015-01, Vol.350 (jan05 2), p.g7635-g7635
Notas: ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
ObjectType-News-3
content type line 23
Descrição: Objective To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry.Design Phase II randomised, single blinded, parallel clinical trial.Setting Eight tertiary neonatal intensive care units in eight European countries.Participants 166 extremely preterm infants born before 28 weeks of gestation: 86 were randomised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring. The only exclusion criterion was a decision not to provide life support.Interventions Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life (experimental) compared with blinded NIRS oxygenation monitoring with standard care (control).Main outcome measures The primary outcome measure was the time spent outside the target range of 55-85% for cerebral oxygenation multiplied by the mean absolute deviation, expressed in %hours (burden of hypoxia and hyperoxia). One hour with an oxygenation of 50% gives 5%hours of hypoxia. Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography.Randomisation Allocation sequence 1:1 with block sizes 4 and 6 in random order concealed for the investigators. The allocation was stratified for gestational age (<26 weeks or ≥26 weeks).Blinding Cerebral oxygenation measurements were blinded in the control group. All outcome assessors were blinded to group allocation.Results The 86 infants randomised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours (interquartile range 9.2-79.5%hours) compared with 81.3 (38.5-181.3) %hours in the control group, a reduction of 58% (95% confidence interval 35% to 73%, P<0.001). In the experimental group the median burden of hypoxia was 16.6 (interquartile range 5.4-68.1) %hours, compared with 53.6 (17.4-171.3) %hours in the control group (P=0.0012). The median burden of hyperoxia was similar between the groups: 1.2 (interquartile range 0.3-9.6) %hours in the experimental group compared with 1.1 (0.1-23.4) %hours in the control group (P=0.98). We found no statistically significant differences between the two groups at term corrected age. No severe adverse reactions were associated with the device.Conclusions Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring.Trial registration ClinicalTrial.gov NCT01590316.
Editor: England: British Medical Journal Publishing Group
Idioma: Inglês

Links

View this record in MEDLINE/PubMed

Voltar para lista de resultados

Anterior Resultado 4 Avançar Ir para próxima página

Realização: Logos de Redes Sociais:

Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial

England: British Medical Journal Publishing Group

Buscando em bases de dados remotas. Favor aguardar.