The SafeBoosC II randomized trial: Treatment guided by near-infrared spectroscopy reduces cerebral hypoxia without changing early biomarkers of brain injury

Pediatric Research

Volumn 79, Issue 4, 2016, Pages 528-535

  Plomgaard, Anne M ^a   Van Oeveren, Wim ^b   Petersen, Tue H ^c   Alderliesten, Thomas ^d   Austin, Topun ^e   Van Bel, Frank ^d   Benders, Manon ^d   Claris, Olivier ^f   Dempsey, Eugene ^g   Franz, Axel ^h   Fumagalli, Monica ⁱ   Gluud, Christian ^c   Hagmann, Cornelia ^j   Hyttel Sorensen, Simon ^a   Lemmers, Petra ^d   Pellicer, Adelina ^k   Pichler, Gerhard ^l   Winkel, Per ^c   Greisen, Gorm ^a  

^a University of Copenhagen   (Denmark)

^b HaemoScan BV   (Netherlands)

^c Mental Health Center Glostrup   (Denmark)

^d UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^e Rosie Maternity Hospital   (United Kingdom)

^f Femme Mere Enfant Hospital   (France)

^g UNIVERSITY COLLEGE CORK   (Ireland)

^h UNIVERSITY OF TÜBINGEN   (Germany)

ⁱ FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^j UNIVERSITY OF ZURICH   (Switzerland)

^k HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^l MEDICAL UNIVERSITY OF GRAZ   (Austria)

more..

Author keywords

[No Author keywords available]

Indexed keywords

FATTY ACID BINDING PROTEIN; NEUROKETAL PROTEIN; PROTEIN; PROTEIN S100B; UNCLASSIFIED DRUG; BIOLOGICAL MARKER;

ARTICLE; BRAIN HYPOXIA; BRAIN INJURY; CONTROLLED STUDY; ELECTROENCEPHALOGRAM; ELECTROENCEPHALOGRAPHY; FETUS BLOOD SAMPLING; HUMAN; MAJOR CLINICAL STUDY; NEAR INFRARED SPECTROSCOPY; NEWBORN; NONHUMAN; OUTCOME ASSESSMENT; OXYGENATION; PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; CLINICAL TRIAL; HYPOXIA, BRAIN; METABOLISM; MULTICENTER STUDY; PATHOPHYSIOLOGY; PHASE 2 CLINICAL TRIAL; PROCEDURES;

BIOMARKERS; BRAIN INJURIES; ELECTROENCEPHALOGRAPHY; HUMANS; HYPOXIA, BRAIN; INFANT, NEWBORN; SPECTROSCOPY, NEAR-INFRARED;

EID: 84964380588     PISSN: 00313998     EISSN: 15300447     Source Type: Journal    
DOI: 10.1038/pr.2015.266     Document Type: Article

References (43)

1. Moore T, Hennessy EM, Myles J, et al. Neurological and developmental outcome in extremely preterm children born in England in 1995 and 2006: the EPICure studies. BMJ. 2012; 345: e7961.
2. Volpe JJ. Brain injury in premature infants: a complex amalgam of destructive and developmental disturbances. Lancet Neurol. 2009; 8: 110-24.
3. de Vries LS, Benders MJ, Groenendaal F. Imaging the premature brain: ultrasound or MRI?. Neuroradiology. 2013; 55: Suppl 2: 13-22.
4. Horsch S, Muentjes C, Franz A, Roll C. Ultrasound diagnosis of brain atrophy is related to neurodevelopmental outcome in preterm infants. Acta Paediatr. 2005; 94: 1815-21.
5. Brouwer MJ, de Vries LS, Groenendaal F, et al. New reference values for the neonatal cerebral ventricles. Radiology. 2012; 262: 224-33.
6. Wikstrom S, Pupp IH, Rosen I, et al. Early single-channel aEEG/EEG predicts outcome in very preterm infants. Acta Paediatr. 2012; 101: 719-26.
7. West CR, Harding JE, Williams CE, Nolan M, Battin MR. Cot-side electroencephalography for outcome prediction in preterm infants: observational study. Arch Dis Child Fetal Neonatal Ed. 2011; 96: F108-13.
8. Gazzolo D, Bruschettini M, Lituania M, Serra G, Bonacci W, Michetti F. Increased urinary S100B protein as an early indicator of intraventricular hemorrhage in preterm infants: correlation with the grade of hemorrhage. Clin Chem. 2001; 47: 1836-8.
9. Thorngren-Jerneck K, Alling C, Herbst A, Amer-Wahlin I, Marsal K. S100 protein in serum as a prognostic marker for cerebral injury in term newborn infants with hypoxic ischemic encephalopathy. Pediatr Res. 2004; 55: 406-12.
10. Teunissen CE, Veerhuis R, De Vente J, et al. Brain-specific fatty acid-binding protein is elevated in serum of patients with dementia-related diseases. Eur J Neurol. 2011; 18: 865-71.
11. Inder T, Mocatta T, Darlow B, Spencer C, Volpe JJ, Winterbourn C. Elevated free radical products in the cerebrospinal fluid of VLBW infants with cerebral white matter injury. Pediatr Res. 2002; 52: 213-8.
12. Pellicer A, Greisen G, Benders M, et al. The SafeBoosC phase II randomised clinical trial: a treatment guideline for targeted near-infrared-derived cerebral tissue oxygenation versus standard treatment in extremely preterm infants. Neonatology. 2013; 104: 171-8.
13. Hyttel-Sorensen S, Pellicer A, Alderliesten T, et al. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial. BMJ. 2015; 350: g7635.
14. Gluud C, Brok J, Gong Y, Koretz RL. Hepatology may have problems with putative surrogate outcome measures. J Hepatol. 2007; 46: 734-42.
15. Buyse M, Molenberghs G, Paoletti X, et al. Statistical evaluation of surrogate endpoints with examples from cancer clinical trials. Biom J. 2015; e-pub ahead of print February 2015
16. Molenberghs G, Burzykowski T, Alonso A, Assam P, Tilahun A, Buyse M A unified framework for the evaluation of surrogate endpoints in mentalhealth clinical trials. Stat Methods Med Res. 2010; 19: 205-36.
17. Inder TE, Buckland L, Williams CE, et al. Lowered electroencephalographic spectral edge frequency predicts the presence of cerebral white matter injury in premature infants. Pediatrics. 2003; 111: 27-33.
18. Sauzet O, Wright KC, Marston L, Brocklehurst P, Peacock JL. Modelling the hierarchical structure in datasets with very small clusters: a simulation study to explore the effect of the proportion of clusters when the outcome is continuous. Stat Med. 2013; 32: 1429-38.
19. Hartley C, Berthouze L, Mathieson SR, et al. Long-range temporal correlations in the EEG bursts of human preterm babies. PLoS One. 2012; 7: e31543.
20. Wikstrom S, Lundin F, Ley D, et al. Carbon dioxide and glucose affect electrocortical background in extremely preterm infants. Pediatrics. 2011; 127: e1028-34.
21. Victor S, Appleton RE, Beirne M, Marson AG, Weindling AM. Spectral analysis of electroencephalography in premature newborn infants: normal ranges. Pediatr Res. 2005; 57: 336-41.
22. Lacey DJ, Topper WH, Buckwald S, Zorn WA, Berger PE. Preterm verylow-birth-weight neonates: relationship of EEG to intracranial hemorrhage, perinatal complications, and developmental outcome. Neurology. 1986; 36: 1084-7.
23. Pressler RM, Boylan GB, Morton M, Binnie CD, Rennie JM. Early serial EEG in hypoxic ischaemic encephalopathy. Clin Neurophysiol. 2001; 112: 31-7.
24. van Laerhoven H, de Haan TR, Offringa M, Post B, van der Lee JH. Prognostic tests in term neonates with hypoxic-ischemic encephalopathy: a systematic review. Pediatrics. 2013; 131: 88-98.
25. Victor S, McKeering CM, Roberts SA, Fullwood C, Gaydecki PA. Effect of permissive hypercapnia on background cerebral electrical activity in premature babies. Pediatr Res. 2014; 76: 184-9.
26. Fogtmann EP, Plomgaard AM, Greisen G, Gluud C. Prognostic accuracy of amplitude-integrated electroencephalogram or electroencephalogram in preterm infants: a systematic review. PROSPERO 2014. (http://.www.crd.york.ac.uk/PROSPERO-REBRANDING/display-record. asp?ID=CRD42014010514). Accessed 14 July 2014.
27. Bjerre I, Hellstrom-Westas L, Rosen I, Svenningsen N. Monitoring of cerebral function after severe asphyxia in infancy. Arch Dis Child. 1983; 58: 997-1002.
28. Iyer KK, Roberts JA, Metsaranta M, Finnigan S, Breakspear M, Vanhatalo S. Novel features of early burst suppression predict outcome after birth asphyxia. Ann Clin Transl Neurol. 2014; 1: 209-14.
29. Eskesen V, Springborg JB, Unden J, Romner B. Initial handling of minimal, light and moderate head traumas in adults. Ugeskr L.ger. 2014; 176: V09130559.
30. Donato R, Sorci G, Riuzzi F, et al. S100Bs double life: intracellular regulator and extracellular signal. Biochim Biophys Acta. 2009; 1793: 1008-22.
31. Gazzolo D, Vinesi P, Bartocci M, et al. Elevated S100 blood level as an early indicator of intraventricular hemorrhage in preterm infants. Correlation with cerebral Doppler velocimetry. J Neurol Sci. 1999; 170: 32-5.
32. Rogers LK, Graf AE, Bhatia A, Leonhart KL, Oza-Frank R. Associations between maternal and infant morbidities and sRAGE within the first week of life in extremely preterm infants. PLoS One. 2013; 8: e82537.
33. Subbaswamy A, Hsu AA, Weinstein S, Bell MJ. Correlation of cerebral near-infrared spectroscopy (cNIRS) and neurological markers in critically ill children. Neurocrit Care. 2009; 10: 129-35.
34. Wunderlich MT, Hanhoff T, Goertler M, et al. Release of brain-Type and heart-Type fatty acid-binding proteins in serum after acute ischaemic stroke. J Neurol. 2005; 252: 718-24.
35. Brame CJ, Salomon RG, Morrow JD, Roberts LJ 2nd. Identification of extremely reactive gamma-ketoaldehydes (isolevuglandins) as products of the isoprostane pathway and characterization of their lysyl protein adducts. J Biol Chem. 1999; 274: 13139-46.
36. Vesoulis ZA, Inder TE, Woodward LJ, Buse B, Vavasseur C, Mathur AM. Early electrographic seizures, brain injury, and neurodevelopmental risk in the very preterm infant. Pediatr Res. 2014; 75: 564-9.
37. Hou X, Ding H, Teng Y, et al. Research on the relationship between brain anoxia at different regional oxygen saturations and brain damage using near-infrared spectroscopy. Physiol Meas. 2007; 28: 1251-65.
38. Zhang D, Hou X, Liu Y, Zhou C, Luo Y, Ding H. The utility of amplitudeintegrated EEG and NIRS measurements as indices of hypoxic ischaemia in the newborn pig. Clin Neurophysiol. 2012; 123: 1668-75.
39. Kurth CD, McCann JC, Wu J, Miles L, Loepke AW. Cerebral oxygen saturation-Time threshold for hypoxic-ischemic injury in piglets. Anesth Analg. 2009; 108: 1268-77.
40. Tin W, Gupta S. Optimum oxygen therapy in preterm babies. Arch Dis Child Fetal Neonatal Ed. 2007; 92: F143-7.
41. SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010; 362: 1959-69.
42. Hyttel-Sorensen S, Austin T, van Bel F, et al A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial. Trials. 2013; 14: 120.
43. OReilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak-Topeak amplitude in neonatal brain monitoring of premature infants. Clin Neurophysiol. 2012; 123: 2139-53.