Association between Baseline Cortisol Serum Concentrations and the Effect of Prophylactic Hydrocortisone in Extremely Preterm Infants - 22/06/21

Doi : 10.1016/j.jpeds.2020.12.057

Chloe Renolleau, MD ¹, Artemis Toumazi, MSc ², Aurélie Bourmaud, PhD ², Jean-François Benoist, PhD ³, Didier Chevenne, PhD ³, Damir Mohamed, MSc ², Corinne Alberti, PhD ², Valérie Biran, PhD ^1,⁴, Olivier Baud, PhD ^4,^5,^⁎
for the
PREMILOC Trial Study Group^∗
List of investigators of the PREMILOC trial is available at www.jpeds.com (Appendix).
Valérie Biran, Caroline Farnoux, Sophie Soudée, Laure Maury, Michèle Granier, Florence Lebail, Duksha Ramful, Sylvain Samperiz, Alain Beuchée, Karine Guimard, Fatima El Moussawi, Pascal Boileau, Florence Castela, Claire Nicaise, Renaud Vialet, Pierre Andrini, Thierry Debillon, Véronique Zupan-Simunek, Hasinirina Razafimahefa, Anne Coursol, Saïd Merbouche, Pascal Bolot, Jean-Marc Kana, Julie Guichoux, Olivier Brissaud, Gérard Thiriez, Olivier Schulze, Mickael Pomedio, Patrice Morville, Thierry Blanc, Stéphane Marret, Bernard Guillois, Cénéric Alexandre, Stéphane Le Bouëdec, Bertrand Leboucher, Umberto Simeoni, Valérie Lacroze, Pierre Kuhn, Stéphanie Litzler-Renaud, Elodie Zana-Taïeb, Pierre-Henri Jarreau, Sylvain Renolleau, Virginie Meau-Petit, Gilles Cambonie, Aline Rideau Batista-Novais

¹ Neonatal Intensive Care Unit, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbone Paris Cité, Paris, France
² Unit of Clinical Epidemiology, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbonne Paris-Cité, Inserm U1123 and CIC-EC 1426, Paris, France
³ Department of Biochemistry and Hormonology, Assistance Publique-Hôpitaux de Paris, CHU Robert Debré, University Paris Diderot, Sorbone Paris Cité, Paris, France
⁴ Inserm U1141, University Paris Diderot, Sorbone Paris Cité, Paris, France
⁵ Division of Neonatology and Pediatric Intensive Care, Children's University Hospital of Geneva and University of Geneva, Geneva, Switzerland

^∗Reprint requests: Olivier Baud, PhD, Division of Neonatology, Department of Pediatrics, University Hospitals, Bd de Cluse 30, Geneva, Switzerland.Division of NeonatologyDepartment of PediatricsUniversity HospitalsBd de Cluse 30GenevaSwitzerland

Abstract

Objective

To define nomograms of serum cortisol values before 24 hours of postnatal life for extremely preterm infants and determine whether baseline cortisol values affect the benefit/risk ratio of prophylactic hydrocortisone to improve survival without bronchopulmonary dysplasia (BPD).

Study design

We performed a predefined secondary analysis of the multicenter randomized controlled PREMILOC trial that included inborn infants delivered before 28 weeks of gestation. Nomograms of baseline serum cortisol values measured in 325 enrolled patients were determined for male and female neonates and correlated to perinatal events. BPD-free survival and severe adverse events were analyzed in placebo and hydrocortisone groups according to the cortisol z score in multivariate logistic regression models.

Results

Increased cortisol levels measured before 24 hours following birth were associated with a significantly higher chance of BPD-free survival only in placebo-treated infants (aOR [95% CI] 1.57 [1.08-2.27], P = .02) based on sex-specific nomograms for baseline cortisol levels. The cortisol z score for infants treated with prophylactic hydrocortisone predicted a risk of high-grade intraventricular hemorrhage (aOR [95% CI] 1.82 [1.06-3.15], P = .03) and spontaneous intestinal perforation (aOR [95% CI] 4.81 [1.34-17.22], P = .02).

Conclusions

We found no predictive value of baseline cortisol levels for BPD-free survival in infants born extremely preterm treated with hydrocortisone. However, high cortisol levels early after birth were associated with a greater risk of severe intraventricular hemorrhage and spontaneous intestinal perforation in infants treated with hydrocortisone and, therefore, a lower benefit/risk ratio for the treatment.

Trial registration

EudraCT 2007-002041-20, ClinicalTrial.gov: NCT00623740.

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Keywords : bronchopulmonary dysplasia, hydrocortisone, cortisol, extremely preterm birth

Abbreviations : BPD, IVH, PMA, SAE

Mappa

Supported by a research grant from the French Ministry of Health and sponsored by the Département de la Recherche Clinique et du Développement, Assistance Publique-Hôpitaux de Paris (AOM 06 025 and AOM 11 129). The funders had no role in the study design, data collection or analysis, decision to publish, or preparation of the manuscript. The authors declare no conflict of interests.

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Vol 234

P. 65 - luglio 2021 Ritorno al numero

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Association between Baseline Cortisol Serum Concentrations and the Effect of Prophylactic Hydrocortisone in Extremely Preterm Infants - 22/06/21

Abstract

Objective

Study design

Results

Conclusions

Trial registration

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