Efficacy and safety of low-dose versus high-dose hydrocortisone to treat hypotension in neonates: a protocol for a systematic review and meta-analysis

Authors

Katelyn Sushko, Health Sciences, School of Nursing, McMaster University, Hamilton, Ontario, Canada
Nada Al-Rawahi, Health Sciences, School of Nursing, McMaster University, Hamilton, Ontario, Canada
Kristi L. Watterberg, Department of Pediatrics, School of Medicine, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA
John Van Den Anker, University Children's Hospital Basel, Division of Paediatric Pharmacology and Pharmacokinetics, University of Basel, Basel, Basel-Stadt, Switzerland
Catherine Litalien, Division of General Pediatrics, Department of Pediatrics, and the Rosalind & Morris Goodman Family Paediatric Foundations Centre, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Québec, Canada
Jacques Lacroix, Division of Paediatric Critical Care Medicine, Department of Pediatrics, University of Montreal, Montreal, Québec, Canada
Abdul Razak, Division of Neonatology, Department of Pediatrics, King Abdullah Bin Abdulaziz University Hospital, Riyadh, Riyadh Province, Saudi Arabia
Samira Samiee-Zafarghandy, Health Sciences, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada

Document Type

Article

Publication Date

12-1-2021

Abstract

BACKGROUND: Impaired adrenal function is a well-described entity in critically ill term and preterm neonates with systemic hypotension. The standard treatment for neonatal hypotension includes volume expanders and vasopressors. Recent evidence supports the use of glucocorticoids for the primary or rescue treatment of neonatal hypotension associated with impaired adrenal function. However, inconsistency regarding the prescribed dosing regimen to provide the best balance between efficacy and safety in this vulnerable population remains an area of concern.

METHODS: We will conduct a systematic review and meta-analysis to evaluate low-dosing compared with high-dosing regimens of hydrocortisone for the treatment of hypotension in critically ill term, preterm and very low birth weight neonates. Ovid MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and Web of Science will be searched from inception to November 2021. Study screening and selection will be completed as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Our primary outcomes will be (1) an improvement in end-organ perfusion, defined as an increase in blood pressure along with an increase in urine output or a reduction in serum lactate and (2) mortality prior to discharge. Our secondary outcomes will be the development of (1) major neurosensory abnormality, (2) bronchopulmonary dysplasia and (3) the occurrence of adverse events.

DISCUSSION: Hydrocortisone may be beneficial in the treatment of hypotension associated with impaired adrenal function among critically ill neonates. However, its optimal dosing to balance desired efficacy with the risk of adverse events is yet to be determined. Our systematic review and meta-analysis aims to address this evidence gap, providing valuable knowledge for a large audience, including guideline developers, policy-makers and clinicians.

PROSPERO REGISTRATION NUMBER: This protocol is submitted for registration to the international database of prospectively registered systematic reviews (PROSPERO, awaiting registration number).

Publication Title

BMJ Paediatr Open

ISSN

2399-9772

Volume

5

Issue

1

DOI

10.1136/bmjpo-2021-001200

Recommended Citation

Sushko K, Al-Rawahi N, Watterberg K, Van Den Anker J, Litalien C, Lacroix J, Razak A, Samiee-Zafarghandy S. Efficacy and safety of low-dose versus high-dose hydrocortisone to treat hypotension in neonates: a protocol for a systematic review and meta-analysis. BMJ Paediatr Open. 2021 Dec;5(1):e001200. doi: 10.1136/bmjpo-2021-001200. PMID: 35404836; PMCID: PMC8671989.