Two-year neurodevelopmental outcomes of extremely preterm infants treated with early hydrocortisone: treatment effect according to gestational age at birth

被引:47
作者
Baud, Olivier [1 ,2 ,3 ]
Trousson, Clemence [1 ]
Biran, Valerie [1 ,4 ]
Leroy, Emilie [1 ]
Mohamed, Damir [5 ,6 ]
Alberti, Corinne
Farnoux, Caroline [7 ,8 ]
Maury, Laure [7 ,8 ]
Soudee, Sophie [7 ,8 ]
Granier, Michele [9 ]
Lebail, Florence [9 ]
Ramful, Duksha [10 ]
Samperiz, Sylvain [10 ]
Beuchee, Alain [11 ]
Guimard, Karine [11 ]
Boileau, Pascal [12 ]
Castela, Florence [12 ]
El Moussawi, Fatima [12 ]
Nicaise, Claire [13 ]
Vialet, Renaud [13 ]
Andrini, Pierre [14 ]
Debillon, Thierry [14 ]
Razafimahefa, Hasinirina [15 ]
Zupan-Simunek, Veronique [15 ]
Coursol, Anne [16 ]
Merbouche, Said [16 ]
Bolot, Pascal [17 ]
Kana, Jean-Marc [17 ]
Guichoux, Julie [18 ]
Brissaud, Olivier [18 ]
Thiriez, Gerard [19 ]
Schulze, Olivier [19 ]
Pomedio, Mickael [20 ]
Morville, Patrice [20 ]
Blanc, Thierry [21 ]
Marret, Stephane [21 ]
Guillois, Bernard [22 ]
Alexandre, Ceneric [22 ]
Le Bouedec, Stephane [23 ]
Leboucher, Bertrand [23 ]
Simeoni, Umberto [24 ]
Lacroze, Valerie [24 ]
Kuhn, Pierre [25 ]
Litzler-Renaud, Stephanie [25 ]
Zana-Taieb, Elodie [26 ]
Jarreau, Pierre-Henri [26 ]
Renolleau, Sylvain [27 ]
Meau-Petit, Virginie [27 ]
Cambonie, Gilles [28 ]
Novais, Aline Rideau Batista [28 ]
机构
[1] Robert Debre Childrens Hosp, AP HP, Neonatal Intens Care Unit, Paris, France
[2] Childrens Univ Hosp Geneva, Div Neonatol & Paediat Intens Care, Geneva, Switzerland
[3] Univ Geneva, Geneva, Switzerland
[4] Univ Paris Diderot, Sorbone Paris Cite, Inserm U1141, Paris, France
[5] Robert Debre Childrens Hosp, AP HP, Inserm U1123, Unit Clin Epidemiol, Paris, France
[6] Univ Paris Diderot, Sorbonne Paris Cite, CIC EC 1426, Paris, France
[7] CHU Robert Debre, AP HP, Neonatal Intens Care Unit, Paris, France
[8] CHU Robert Debre, AP HP, INSERM U1141, Paris, France
[9] CH Corbeil Essonnes, Neonatal Intens Care Unit, Corbeil Essonnes, France
[10] CHR St Denis, Neonatal & Pediat Intens Care Unit, La Reunion, France
[11] CHU Rennes, Neonatal Intens Care Unit, Rennes, France
[12] CHI Poissy, Neonatal Intens Care Unit, CHI Poissy, France
[13] CHU Hop Nord, AP HP, Neonatal Intens Care Unit, Marseille, France
[14] CHU Grenoble, Neonatal Intens Care Unit, Grenoble, France
[15] CHU Antoine Beclere, AP HP, Neonatal Intens Care Unit, Paris, France
[16] CH Pontoise, Neonatal Intens Care Unit, Pontoise, France
[17] CH St Denis, Neonatal Intens Care Unit, St Denis, Reunion, France
[18] CHU Bordeaux, Neonatal & Pediat Intens Care Unit, Bordeaux, France
[19] CHU Besancon, Neonatal & Pediat Intens Care Unit, Besancon, France
[20] CHU Reims, Neonatal & Pediat Intens Care Unit, Reims, France
[21] CHU Rouen, Neonatal & Pediat Intens Care Unit, Rouen, France
[22] CHU Caen, Neonatal Intens Care Unit, Caen, France
[23] CHU Angers, Neonatal Intens Care Unit, Angers, France
[24] CHU Concept, AP HP, Neonatal Intens Care Unit, Marseille, France
[25] CHU, Neonatal Intens Care Unit, Strasbourg, France
[26] CHU Cochin Broca Hotel Dieu, AP HP, Neonatal Intens Care Unit Port Royal, Paris, France
[27] CHU Armand Trousseau, AP HP, Neonatal & Pediat Intens Care Unit, Paris, France
[28] CHRU Montpellier, Neonatal Intens Care Unit, Montpellier, France
[29] Univ Paris 05, AP HP, AGEPS, Dept Essais Clin,Dept Sante Publ, Paris, France
[30] Univ Calgary, Reg Director Calgary Zone, Sect Head Neonatol, Calgary, AB, Canada
[31] Univ New Mexico, Sch Med, Albuquerque, NM 87131 USA
[32] Direct Rech Clin & Dev, AP HP, Paris, France
[33] Robert Debre Childrens Hosp, AP HP, Unit Clin Epidemiol, Paris, France
来源
ARCHIVES OF DISEASE IN CHILDHOOD-FETAL AND NEONATAL EDITION | 2019年 / 104卷 / 01期
关键词
PATENT DUCTUS-ARTERIOSUS; LOW-DOSE HYDROCORTISONE; BRONCHOPULMONARY DYSPLASIA; CHILDREN BORN; INFLAMMATION; SURVIVAL; THERAPY; INJURY; TERM;
D O I
10.1136/archdischild-2017-313756
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
Objective To determine whether early hydrocortisone treatment in extremely preterm infants affects neurodevelopmental outcomes at 2 years of age according to gestational age at birth. Patients and methods This is an exploratory analysis of neurodevelopmental outcomes by gestational age strata from the PREMILOC trial, in which patients were randomly assigned to receive either placebo or low-dose hydrocortisone and randomisation was stratified by gestational age groups (24-25 and 26-27 weeks of gestation). Neurodevelopmental impairment (NDI) was assessed using a standardised neurological examination and the revised Brunet-Lezine scale at 22 months of corrected age. Results A total of 379 of 406 survivors were evaluated, 96/98 in the gestational age group of 24-25 weeks and 283/308 in the gestational age group of 26-27 weeks. Among surviving infants born at 24-25 weeks, significant improvement in global neurological assessment was observed in the hydrocortisone group compared with the placebo group (P=0.02) with a risk of moderate-to-severe NDI of 2% and 18%, respectively (risk difference 16 (95% CI -28% to -5%)). In contrast, no statistically significant difference between treatment groups was observed in infants born at 26-27 weeks (P= 0.95) with a similar risk of moderate-to-severe NDI of 9% in both groups. The incidence of cerebral palsy or other major neurological impairments were found similar between treatment groups in each gestational group. Conclusions In an exploratory analysis of neurodevelopmental outcomes from the PREMILOC trial, early low-dose hydrocortisone was associated with a statistically significant improvement in neurodevelopmental outcomes in infants born at 24 and 25 weeks of gestation.
引用
收藏
页码:F30 / F35
页数:6
相关论文
共 25 条
[1]   Survival and Morbidity of Preterm Children Born at 22 Through 34 Weeks' Gestation in France in 2011 Results of the EPIPAGE-2 Cohort Study [J].
Ancel, Pierre-Yves ;
Goffinet, Francois .
JAMA PEDIATRICS, 2015, 169 (03) :230-238
[2]   Association Between Early Low-Dose Hydrocortisone Therapy in Extremely Preterm Neonates and Neurodevelopmental Outcomes at 2 Years of Age [J].
Baud, Olivier ;
Trousson, Clemence ;
Biran, Valerie ;
Leroy, Emilie ;
Mohamed, Damir ;
Alberti, Corinne .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2017, 317 (13) :1329-1337
[3]   Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre, randomised trial [J].
Baud, Olivier ;
Maury, Laure ;
Lebail, Florence ;
Ramful, Duksha ;
El Moussawi, Fatima ;
Nicaise, Claire ;
Zupan-Simunek, Veronique ;
Coursol, Anne ;
Beuchee, Alain ;
Bolot, Pascal ;
Andrini, Pierre ;
Mohamed, Damir ;
Alberti, Corinne .
LANCET, 2016, 387 (10030) :1827-1836
[4]   Neurodevelopmental Outcome at 2 Years of Age according to Patent Ductus Arteriosus Management in Very Preterm Infants [J].
Bourgoin, Laura ;
Cipierre, Cecile ;
Hauet, Quentin ;
Basset, Helene ;
Gournay, Veronique ;
Roze, Jean-Christophe ;
Flamant, Cyril ;
Gascoin, Geraldine .
NEONATOLOGY, 2016, 109 (02) :139-146
[5]   Cerebral vascular regulation and brain injury in preterm infants [J].
Brew, Nadine ;
Walker, David ;
Wong, Flora Y. .
AMERICAN JOURNAL OF PHYSIOLOGY-REGULATORY INTEGRATIVE AND COMPARATIVE PHYSIOLOGY, 2014, 306 (11) :R773-R786
[6]  
Brunet O., 1951, Le Developpement Psychologique de la Premiere Enfance
[7]   Very preterm children free of disability or delay at age 2: Predictors of schooling at age 8 A population-based longitudinal study [J].
Charkaluk, M. L. ;
Truffert, P. ;
Marchand-Martin, L. ;
Mur, S. ;
Kaminski, M. ;
Ancel, P. Y. ;
Pierrat, V. .
EARLY HUMAN DEVELOPMENT, 2011, 87 (04) :297-302
[8]   Neurodevelopment of children born very preterm and free of severe disabilities: the Nord-Pas de Calais Epipage cohort study [J].
Charkaluk, M. L. ;
Truffert, P. ;
Fily, A. ;
Ancel, P. Y. ;
Pierrat, V. .
ACTA PAEDIATRICA, 2010, 99 (05) :684-689
[9]   GLUCOCORTICOIDS ALTER THE SENSITIVITY OF THE LAMB DUCTUS-ARTERIOSUS TO PROSTAGLANDIN-E2 [J].
CLYMAN, RI ;
MAURAY, F ;
ROMAN, C ;
RUDOLPH, AM ;
HEYMANN, MA .
JOURNAL OF PEDIATRICS, 1981, 98 (01) :126-128
[10]   EFFECTS OF ANTENATAL GLUCOCORTICOID ADMINISTRATION ON DUCTUS-ARTERIOSUS OF PRETERM LAMBS [J].
CLYMAN, RI ;
MAURAY, F ;
ROMAN, C ;
HEYMANN, MA ;
BALLARD, PL ;
RUDOLPH, AM ;
PAYNE, B .
AMERICAN JOURNAL OF PHYSIOLOGY, 1981, 241 (03) :H415-H420