1. Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller A-B, Narwal R, et al. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012;379:2162–72.
2. Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, et al. Neonatal Outcomes of Extremely Preterm Infants From the NICHD Neonatal Research Network. Pediatrics. 2010;126:443–56.
3. Adams-Chapman I, Heyne RJ, DeMauro SB, Duncan AF, Hintz SR, Pappas A, et al. Neurodevelopmental Impairment Among Extremely Preterm Infants in the Neonatal Research Network. Pediatrics. 2018;141:e20173091.
4. Volpe JJ. Brain injury in the premature infant: neuropathology, clinical aspects and pathogenesis. Semin Pediatr Neurol. 1998;5:135–51.
5. Ward RM, Beachy JC. Neonatal complications following preterm birth. BJOG An Int J Obstet Gynaecol. 2003;110:8–16.
6. Behrman RE, Butler AS. Preterm Birth: Causes, Consequences, and Prevention. 1st ed. Washington DC: National Academy of Sciences; 2007.
7. Stephens BE, Vohr BR. Neurodevelopmental Outcome of the Premature Infant. Pediatr Clin North Am. 2009;56:631–46.
8. Kluckow M. Low systemic blood flow and pathophysiology of the preterm transitional circulation. Early Hum Dev. 2005;81:429–37.
9. Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: A study of infants with birth weights less than 1,500 gm. J Pediatr. 1978;92:529–34.
10. Guzzetta F, Shackelford GD, Volpe S, Perlman JM, Volpe JJ. Periventricular intraparenchymal echodensities in the premature newborn: critical determinant of neurologic outcome. Pediatrics. 1986;78:995–1006.
11. Volpe JJ. Brain injury in premature infants: a complex amalgam of destructive and developmental disturbances. Lancet Neurol. 2009;8:110–24.
12. Cordeiro CN, Tsimis M, Burd I. Infections and Brain Development. Obstet Gynecol Surv. 2015;70:644–55.
13. Prado EL, Dewey KG. Nutrition and brain development in early life. Nutr Rev. 2014;72:267–84.
14. Perlman JM. White matter injury in the preterm infant: An important determination of abnormal neurodevelopment outcome. Early Hum Dev. 1998;53:99–120.
15. Greisen G, Vannucci RC. Is periventricular leucomalacia a result of hypoxic-ischaemic injury? Hypocapnia and the preterm brain. Biol Neonate. 2001;79:194–200.
16. Perlman M, Volpe J. Are Venous Circulatory Abnormalities Important in the Pathogenesis of Hemorrhagic and / or lschemic Cerebral Injury ? Pediatrics. 1987;80:705–11.
17. Alderliesten T, Dix L, Baerts W, Caicedo A, van Huffel S, Naulaers G, et al. Reference values of regional cerebral oxygen saturation during the first 3 days of life in preterm neonates. Pediatr Res. 2016;79:55–64.
18. Hyttel-Sorensen S, Austin T, van Bel F, Benders M, Claris O, Dempsey E, 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 tria. Trials. 2013;14:120.
19. Riera J, Hyttel-Sorensen S, Bravo MC, Cabañas F, López-Ortego P, Sanchez L, et al. The SafeBoosC phase II clinical trial: an analysis of the interventions related with the oximeter readings. Arch Dis Child - Fetal Neonatal Ed. 2016;101:F333–8.
20. Guideline on Good Clinical Practice E6(R2). European Medicines Agency, Committee for Human Medicinal Products. 2017.
21. Chan A-W, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586–e7586.
22. Davidson JO, Wassink G, van den Heuij LG, Bennet L, Gunn AJ. Therapeutic Hypothermia for Neonatal Hypoxic–Ischemic Encephalopathy – Where to from Here? Front Neurol. 2015;6:198.
23. Pellicer A, Greisen G, Benders M, Claris O, Dempsey E, Fumagalli 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.
24. Kleiser S, Ostojic D, Andresen B, Nasseri N, Isler H, Scholkmann F, et al. Comparison of tissue oximeters on a liquid phantom with adjustable optical properties: an extension. Biomed Opt Express. 2018;9:86–101.
25. Vermont Oxford Network. Manual of Operations: Part 2 Data Definitions & Infant Data Forms. In 2018.
26. Jakobsen J, Gluud C, Winkel P, Lange T, Wetterslev J. The thresholds for statistical and clinical significance – a five-step procedure for evaluation of intervention effects in randomised clinical trials. BMC Med Res Methodol. 2014;14:34.
27. Greisen G, van Bel F. Equipoise is necessary for randomising patients to clinical trials. Acta Paediatr Int J Paediatr. 2016;105:1259–60.
28. Hyttel-Sørensen S, Greisen G, Als-Nielsen B, Gluud C. Cerebral near-infrared spectroscopy monitoring for prevention of brain injury in very preterm infants (Review). 2017;1–25.
29. Hunter CL, Oei JL, Suzuki K, Lui K, Schindler T. Patterns of use of near-infrared spectroscopy in neonatal intensive care units: international usage survey. Acta Paediatr. 2018;107:1198–204.
30. Bevan PJW. Should Cerebral Near-infrared Spectroscopy be Standard of Care in Adult Cardiac Surgery? Hear Lung Circ. 2015;24:544–50.
31. Savović J, Turner RM, Mawdsley D, Jones HE, Beynon R, Higgins JPT, et al. Association Between Risk-of-Bias Assessments and Results of Randomized Trials in Cochrane Reviews: The ROBES Meta-Epidemiologic Study. Am J Epidemiol. 2018;187:1113–22.
32. Hrobjartsson A, Thomsen ASS, Emanuelsson F, Tendal B, Hilden J, Boutron I, et al. Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors. Can Med Assoc J. 2013;185:E201–11.
33. Hróbjartsson A, Thomsen ASS, Emanuelsson F, Tendal B, Rasmussen JV, Hilden J, et al. Observer bias in randomized clinical trials with time-to-event outcomes: Systematic review of trials with both blinded and non-blinded outcome assessors. Int J Epidemiol. 2014;43:937–48.
34. Hróbjartsson A, Emanuelsson F, Skou Thomsen AS, Hilden J, Brorson S. Bias due to lack of patient blinding in clinical trials. A systematic review of trials randomizing patients to blind and nonblind sub-studies. Int J Epidemiol. 2014;43:1272–83.
35. Anthon CT, Granholm A, Perner A, Laake JH, Møller MH. No firm evidence that lack of blinding affects estimates of mortality in randomized clinical trials of intensive care interventions: a systematic review and meta-analysis. J Clin Epidemiol. 2018;100:71–81.
36. Hintz SR, Slovis T, Bulas D, Meurs KP Van. Interobserver reliability and accuracy of cranial ultrasound interpretation in premature infants. J Pediatr. 2007;150:592–6.
37. Yelland LN, Sullivan TR, Collins CT, Price DJ, McPhee AJ, Lee KJ. Accounting for twin births in sample size calculations for randomised trials. Paediatr Perinat Epidemiol. 2018;32:380–7.
38. Hyttel-Sorensen S, Pellicer A, Alderliesten T, Austin T, Van Bel F, Benders M, et al. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: Phase II randomised clinical trial. BMJ. 2015;350:1–11.
39. Campbell M. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000;321:694–6.
40. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390–a2390.
41. Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167:40.
42. Brierley J, Larcher V. Emergency research in children: options for ethical recruitment. J Med Ethics. 2011;37:429–32.
43. Beauchamp TL, Childress JF, Press. OU. Principles of biomedical ethics. 7th ed. Oxford: Oxford University Press; 2012.
44. Mason SA, Allmark PJ. Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet. 2000;356:2045–51.
45. Gale C, Juszczak E. A paediatrician’s guide to clinical trials units. Arch Dis Child - Educ Pract Ed. 2016;101:265–7.
46. Gale C, Hyde MJ, Modi N. Research ethics committee decision-making in relation to an efficient neonatal trial. Arch Dis Child - Fetal Neonatal Ed. 2017;102:F291–8.
47. Hafström M, Källén K, Serenius F, Maršál K, Rehn E, Drake H, et al. Cerebral Palsy in Extremely Preterm Infants. Pediatrics. 2018;141:e20171433.
48. Roberts G, Anderson PJ, De Luca C, Doyle LW. Changes in neurodevelopmental outcome at age eight in geographic cohorts of children born at 22-27 weeks’ gestational age during the 1990s. Arch Dis Child - Fetal Neonatal Ed. 2010;95:F90–4.
49. Stanley F, Blair E, Alberman E. Cerebral palsies: epidemiology and casual pathways. 1st ed. Cambridge: Cambridge University Press; 2000