Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): A double-blind, placebo-controlled, multicentre, randomised trial

The Lancet

Volumn 387, Issue 10030, 2016, Pages 1827-1836

  Baud, Olivier ^a,j   Maury, Laure ^a   Lebail, Florence ^b   Ramful, Duksha ^c   El Moussawi, Fatima ^d   Nicaise, Claire ^e   Zupan Simunek, Véronique ^a   Coursol, Anne ^f   Beuchée, Alain ^g   Bolot, Pascal ^h   Andrini, Pierre ⁱ   Mohamed, Damir ^j   Alberti, Corinne ^j  

^a Section of Radiology   (France)

^b CENTRE HOSPITALIER SUD FRANCILIEN   (France)

^c CHR Saint Denis   (France)

^d CENTRE HOSPITALIER INTERCOMMUNAL   (France)

^e HÔPITAL NORD   (France)

^f Centre Hospitalier de Pontoise   (France)

^g RENNES UNIVERSITY HOSPITAL   (France)

^h Centre Hospitalier de Saint Denis   (France)

ⁱ GRENOBLE UNIVERSITY HOSPITAL   (France)

^j HÔPITAL ROBERT DEBRÉ   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HYDROCORTISONE SODIUM SUCCINATE; PLACEBO; ANTIINFLAMMATORY AGENT; HYDROCORTISONE;

ARTICLE; BRAIN DAMAGE; CONTROLLED STUDY; DIGESTIVE SYSTEM PERFORATION; DOUBLE BLIND PROCEDURE; DRUG EFFECT; FEMALE; GESTATIONAL AGE; HUMAN; INFANT; LOW DRUG DOSE; LUNG DYSPLASIA; LUNG HEMORRHAGE; MAJOR CLINICAL STUDY; MALE; MATERNITY WARD; MULTICENTER STUDY; NECROTIZING ENTEROCOLITIS; NEWBORN INTENSIVE CARE; PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETINOPATHY; SEPSIS; SURVIVAL; TERTIARY HEALTH CARE; ANALOGS AND DERIVATIVES; BRONCHOPULMONARY DYSPLASIA; CLINICAL TRIAL; FRANCE; NEWBORN; STATISTICAL MODEL; TREATMENT OUTCOME;

ANTI-INFLAMMATORY AGENTS; BRONCHOPULMONARY DYSPLASIA; DOUBLE-BLIND METHOD; FEMALE; FRANCE; HUMANS; HYDROCORTISONE; INFANT, EXTREMELY PREMATURE; INFANT, NEWBORN; LOGISTIC MODELS; MALE; TREATMENT OUTCOME;

EID: 84968912304     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(16)00202-6     Document Type: Article

References (30)

1. AH Jobe The new bronchopulmonary dysplasia Curr Opin Pediatr 23 2011 167 172
2. BJ Stoll, NI Hansen, EF Bell et al. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network Pediatrics 126 2010 443 456
3. PY Ancel, F Goffinet EPIPAGE-2 Writing Group Survival and morbidity of preterm children born at 22 through 34 weeks' gestation in France in 2011: results of the EPIPAGE-2 cohort study JAMA Pediatr 169 2015 230 238
4. K Watterberg Evidence-based neonatal pharmacotherapy: postnatal corticosteroids Clin Perinatol 39 2012 47 59
5. MC Walsh, Q Yao, JD Horbar, JH Carpenter, SK Lee, A Ohlsson Changes in the use of postnatal steroids for bronchopulmonary dysplasia in 3 large neonatal networks Pediatrics 118 2006 e1328 e1335
6. KL Watterberg, SM Scott Evidence of early adrenal insufficiency in babies who develop bronchopulmonary dysplasia Pediatrics 95 1995 120 125
7. KL Watterberg, JS Gerdes, KL Gifford, HM Lin Prophylaxis against early adrenal insufficiency to prevent chronic lung disease in premature infants Pediatrics 104 1999 1258 1263
8. KL Watterberg, JS Gerdes, CH Cole et al. Prophylaxis of early adrenal insufficiency to prevent bronchopulmonary dysplasia: a multicenter trial Pediatrics 114 2004 1649 1657
9. O Peltoniemi, MA Kari, K Heinonen et al. Pretreatment cortisol values may predict responses to hydrocortisone administration for the prevention of bronchopulmonary dysplasia in high-risk infants J Pediatr 146 2005 632 637
10. F Bonsante, G Latorre, S Iacobelli et al. Early low-dose hydrocortisone in very preterm infants: a randomized, placebo-controlled trial Neonatology 91 2007 217 221
11. SS Shah, A Ohlsson, HL Halliday, VS Shah Inhaled versus systemic corticosteroids for the treatment of chronic lung disease in ventilated very low birth weight preterm infants Cochrane Database Syst Rev 5 2012 CD002057
12. E Autret-Leca, S Bauer, C Alberti et al. Postnatal glucocorticoids in preterm neonates: use in French neonatal centres in 2006 Arch Dis Child Fetal Neonatal Ed 93 2008 F398
13. KF Schulz, DG Altman, D Moher CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials Trials 11 2010 32
14. N Mamelle, F Munoz, H Grandjean Fetal growth from the AUDIPOG study. Establishment of reference curves J Gynecol Obstet Biol Reprod 25 1996 61 70
15. KL Watterberg, ML Shaffer, JS Garland et al. Effect of dose on response to adrenocorticotropin in extremely low birth weight infants J Clin Endocrinol Metab 90 2005 6380 6385
16. MC Walsh, D Wilson-Costello, A Zadell, N Newman, A Fanaroff Safety, reliability, and validity of a physiologic definition of bronchopulmonary dysplasia J Perinatol 23 2003 451 456
17. J Whitehead The design and analysis of sequential clinical trials. Revised 2nd edn. 1997 John Wiley & Sons Ltd Chichester
18. MPS Research Unit Pest 4: operating manual 2000 University of Reading Reading
19. J Whitehead Group sequential trials revisited: simple implementation using SAS Stat Methods Med Res 20 2011 635 656
20. C Alberti, F Metivier, P Landais, E Thervet, C Legendre, S Chevret Improving estimates of event incidence over time in populations exposed to other events. Application to three large databases J Clin Epidemiol 56 2003 536 545
21. LW Doyle, RA Ehrenkranz, HL Halliday Early (<8 days) postnatal corticosteroids for preventing chronic lung disease in preterm infants Cochrane Database Syst Rev 5 2014 CD001146
22. OM Peltoniemi, A Lano, R Puosi et al. Trial of early neonatal hydrocortisone: two-year follow-up Neonatology 95 2009 240 247
23. KL Watterberg, ML Shaffer, MJ Mishefske et al. Growth and neurodevelopmental outcomes after early low-dose hydrocortisone treatment in extremely low birth weight infants Pediatrics 120 2007 40 48
24. KJ Kersbergen, LS de Vries, BJ van Kooij et al. Hydrocortisone treatment for bronchopulmonary dysplasia and brain volumes in preterm infants J Pediatr 163 2013 666 671
25. KJ Rademaker, CS Uiterwaal, F Groenendaal et al. Neonatal hydrocortisone treatment: neurodevelopmental outcome and MRI at school age in preterm-born children J Pediatr 150 2007 351 357
26. KJ Rademaker, WB de Vries Long-term effects of neonatal hydrocortisone treatment for chronic lung disease on the developing brain and heart Semin Fetal Neonatal Med 14 2009 171 177
27. VM Heine, DH Rowitch Hedgehog signaling has a protective effect in glucocorticoid-induced mouse neonatal brain injury through an 11betaHSD2-dependent mechanism J Clin Invest 119 2009 267 277
28. EW Tam, V Chau, DM Ferriero et al. Preterm cerebellar growth impairment after postnatal exposure to glucocorticoids Sci Transl Med 3 2011 105ra105
29. NA Parikh, KA Kennedy, RE Lasky, GE McDavid, JE Tyson Pilot randomized trial of hydrocortisone in ventilator-dependent extremely preterm infants: effects on regional brain volumes J Pediatr 162 2013 685 690
30. MJ Stark, IM Wright, VL Clifton Sex-specific alterations in placental 11beta-hydroxysteroid dehydrogenase 2 activity and early postnatal clinical course following antenatal betamethasone Am J Physiol Regul Integr Comp Physiol 297 2009 R510 R514