Prophylactic hydrocortisone in extremely preterm infants and brain MRI abnormality.
Brain
/ diagnostic imaging
Brain Injuries
/ diagnostic imaging
Bronchopulmonary Dysplasia
/ epidemiology
Dose-Response Relationship, Drug
Female
Humans
Hydrocortisone
/ administration & dosage
Infant, Extremely Premature
/ growth & development
Infant, Newborn
Logistic Models
Magnetic Resonance Imaging
Male
Neurodevelopmental Disorders
intensive care
neonatology
Journal
Archives of disease in childhood. Fetal and neonatal edition
ISSN: 1468-2052
Titre abrégé: Arch Dis Child Fetal Neonatal Ed
Pays: England
ID NLM: 9501297
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
12
06
2019
revised:
18
12
2019
accepted:
02
01
2020
pubmed:
26
1
2020
medline:
4
9
2020
entrez:
26
1
2020
Statut:
ppublish
Résumé
To determine whether early low-dose hydrocortisone treatment in extremely preterm infants is associated with brain damage assessed by MRI at term equivalent of age (TEA). This is a predefined secondary analysis of brain abnormalities, observed by MRI at TEA, of patients randomly assigned to receive either placebo or hydrocortisone in the PREMILOC trial. Outcomes were based on brain abnormalities graded according to Kidokoro scores. Among 412 survivors at TEA, 300 MRIs were performed and 295 were suitable for analysis. Kidokoro scoring was completed for 119/148 and 110/147 MRIs in the hydrocortisone and placebo groups, respectively. The distribution of the Kidokoro white matter (WM) subscore and other subscores was not significantly different between the two groups. There was, however, a significant association between a higher overall Kidokoro score and hydrocortisone treatment (5.84 (SD 3.51) for hydrocortisone and 4.98 (SD 2.52) for placebo; mean difference, 0.86; 95% CI 0.06 to 1.66; p=0.04). However, hydrocortisone was not statistically associated with moderate-to-severe brain lesions (Kidokoro overall score ≥6) in a multivariate logistic regression model accounting for potential confounding variables (adjusted OR (95% CI) 1.27 (0.75 to 2.14), p=0.38). Bronchopulmonary dysplasia at 36 weeks postmenstrual age significantly predicted both WM damage (adjusted OR (95% CI) 2.70 (1.03 to 7.14), p=0.04) and global brain damage (adjusted OR (95% CI) 2.18 (1.19 to 3.99), p=0.01). Early hydrocortisone exposure in extremely preterm infants is not statistically associated with either WM brain damage or overall moderate-to-severe brain lesions when adjusted for other neonatal variables. EudraCT number 2007-002041-20, NCT00623740.
Identifiants
pubmed: 31980445
pii: archdischild-2019-317720
doi: 10.1136/archdischild-2019-317720
doi:
Substances chimiques
Hydrocortisone
WI4X0X7BPJ
Banques de données
ClinicalTrials.gov
['NCT00623740']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
520-525Investigateurs
Ali Bilal
(A)
Caroline Farnoux
(C)
Sophie Soudée
(S)
Laure Maury
(L)
Michèle Granier
(M)
Florence Lebail
(F)
Duksha Ramful
(D)
Sylvain Samperiz
(S)
Alain Beuchée
(A)
Karine Guimard
(K)
Fatima El Moussawi
(FE)
Pascal Boileau
(P)
Florence Castela
(F)
Claire Nicaise
(C)
Renaud Vialet
(R)
Pierre Andrini
(P)
Thierry Debillon
(T)
Véronique Zupan-Simunek
(V)
Hasinirina Razafimahefa
(H)
Anne Coursol
(A)
Saïd Merbouche
(S)
Pascal Bolot
(P)
Jean-Marc Kana
(JM)
Julie Guichoux
(J)
Olivier Brissaud
(O)
Gérard Thiriez
(G)
Olivier Schulze
(O)
Mickael Pomedio
(M)
Patrice Morville
(P)
Thierry Blanc
(T)
Stéphane Marret
(S)
Bernard Guillois
(B)
Cénéric Alexandre
(C)
Stéphane Le Bouëdec
(SL)
Bertrand Leboucher
(B)
Umberto Simeoni
(U)
Valérie Lacroze
(V)
Pierre Kuhn
(P)
Stéphanie Litzler-Renaud
(S)
Elodie Zana-Taïeb
(E)
Pierre-Henri Jarreau
(PH)
Sylvain Renolleau
(S)
Virginie Meau-Petit
(V)
Gilles Cambonie
(G)
Annick Tibi
(A)
Amel Ouslimani
(A)
Elodie Soler
(E)
Sandra Argues
(S)
Tania Rilcy
(T)
Adyla Yacoubi
(A)
Sabrina Verchere
(S)
Informations de copyright
© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.