SuPreme Study: a protocol to study the neuroprotective potential of sulfate among very/extremely preterm infants

Loading...
Thumbnail Image
File version

Version of Record (VoR)

Author(s)
Hurrion, EM
Badawi, N
Boyd, RN
Morgan, C
Gibbons, K
Hennig, S
Koorts, P
Chauhan, M
Bowling, F
Flenady, V
Kumar, S
Dawson, PA
Griffith University Author(s)
Primary Supervisor
Other Supervisors
Editor(s)
Date
2023
Size
File type(s)
Location
Abstract

Introduction Antenatal maternal magnesium sulfate (MgSO 4) administration is a proven efficacious neuroprotective treatment reducing the risk of cerebral palsy (CP) among infants born preterm. Identification of the neuroprotective component with target plasma concentrations could lead to neonatal treatment with greater efficacy and accessibility. Methods and analysis This is a prospective observational cohort study, in three tertiary Australian centres. Participants are preterm infants, irrespective of antenatal MgSO 4 exposure, born in 2013-2020 at 24 +0 to 31 +6 weeks gestation, and followed up to 2 years corrected age (CA) (to September 2023). 1595 participants are required (allowing for 17% deaths/loss to follow-up) to detect a clinically significant reduction (30% relative risk reduction) in CP when sulfate concentration at 7 days of age is 1 SD above the mean. A blood sample is collected on day 7 of age for plasma sulfate and magnesium measurement. In a subset of participants multiple blood and urine samples are collected for pharmacokinetic studies, between days 1-28, and in a further subset mother/infant blood is screened for genetic variants of sulfate transporter genes. The primary outcome is CP. Surviving infants are assessed for high risk of CP at 12-14 weeks CA according to Prechtl's Method to assess General Movements. Follow-up at 2 years CA includes assessments for CP, cognitive, language and motor development, and social/behavioural difficulties. Multivariate analyses will examine the association between day 7 plasma sulfate/magnesium concentrations with adverse neurodevelopmental outcomes. A population pharmacokinetic model for sulfate in the preterm infant will be created using non-linear mixed-effects modelling. Ethics and dissemination The study has been approved by Mater Misericordiae Ltd Human Research Ethics Committee (HREC/14/MHS/188). Results will be disseminated in peer-reviewed journal publications, and provided to the funding bodies. Using consumer input, a summary will be prepared for participants and consumer groups.

Journal Title

BMJ Open

Conference Title
Book Title
Edition
Volume

13

Issue

7

Thesis Type
Degree Program
School
Publisher link
Patent number
Funder(s)
Grant identifier(s)
Rights Statement
Rights Statement

© Author(s) (or their employer(s)) 2023. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Item Access Status
Note
Access the data
Related item(s)
Subject

Biomedical and clinical sciences

Health sciences

Psychology

Developmental neurology & neurodisability

NEONATOLOGY

Paediatric neurology

Persistent link to this record
Citation

Hurrion, EM; Badawi, N; Boyd, RN; Morgan, C; Gibbons, K; Hennig, S; Koorts, P; Chauhan, M; Bowling, F; Flenady, V; Kumar, S; Dawson, PA, SuPreme Study: a protocol to study the neuroprotective potential of sulfate among very/extremely preterm infants, BMJ Open, 2023, 13 (7), pp. e076130

Collections