Prophylactic hydrocortisone in extremely preterm infants and brain MRI abnormality.


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
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

520-525

Investigateurs

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.

Auteurs

Marianne Alison (M)

Pediatric Radiology, Hôpital Universitaire Robert Debré, Paris, France.

Bogdana Tilea (B)

Pediatric Radiology, Hôpital Universitaire Robert Debré, Paris, France.

Artemis Toumazi (A)

Pediatric Radiology, Hôpital Universitaire Robert Debré, Paris, France.

Valérie Biran (V)

Neonatal Intensive Care Unit, Hopital Universitaire Robert Debre, Paris, Île-de-France, France.
Inserm U1141, University of Paris, Paris, France.

Damir Mohamed (D)

Centre d'Investigation Clinique-Epidémiologie Clinique, Hopital Universitaire Robert Debre, Paris, France.

Corinne Alberti (C)

Centre d'Investigation Clinique-Epidémiologie Clinique, Hopital Universitaire Robert Debre, Paris, France.

Aurélie Bourmaud (A)

Pediatric Radiology, Hôpital Universitaire Robert Debré, Paris, France.

Olivier Baud (O)

Inserm U1141, University of Paris, Paris, France olivier.baud@hcuge.ch.
DFEA, Hôpitaux Universitaires de Genève, Geneva, Switzerland.

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Classifications MeSH