Hearing loss in Australian First Nations children at 6-monthly assessments from age 12 to 36 months: Secondary outcomes from randomised controlled trials of novel pneumococcal conjugate vaccine schedules.

Author(s)
Leach, Amanda Jane
Wilson, Nicole
Arrowsmith, Beth
Beissbarth, Jemima
Mulholland, Kim
Santosham, Mathuram
Torzillo, Paul John
McIntyre, Peter
Smith-Vaughan, Heidi
Skull, Sue A
Oguoma, Victor M
Chatfield, Mark D
Lehmann, Deborah
Brennan-Jones, Christopher G
Binks, Michael J
Licciardi, Paul V
Andrews, Ross M
Snelling, Tom
Carapetis, Jonathan
Krause, Vicki
Chang, Anne B
Morris, Peter
Publication Date
2024-06-03
Abstract
In Australian remote communities, First Nations children with otitis media (OM)-related hearing loss are disproportionately at risk of developmental delay and poor school performance, compared to those with normal hearing. Our objective was to compare OM-related hearing loss in children randomised to one of 2 pneumococcal conjugate vaccine (PCV) formulations.In 2 sequential parallel, open-label, randomised controlled trials (the PREVIX trials), eligible infants were first allocated 1:1:1 at age 28 to 38 days to standard or mixed PCV schedules, then at age 12 months to PCV13 (13-valent pneumococcal conjugate vaccine, +P) or PHiD-CV10 (10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine, +S) (1:1). Here, we report prevalence and level of hearing loss outcomes in the +P and +S groups at 6-monthly scheduled assessments from age 12 to 36 months. From March 2013 to September 2018, 261 infants were enrolled and 461 hearing assessments were performed. Prevalence of hearing loss was 78% (25/32) in the +P group and 71% (20/28) in the +S group at baseline, declining to 52% (28/54) in the +P groups and 56% (33/59) in the +S group at age 36 months. At primary endpoint age 18 months, prevalence of moderate (disabling) hearing loss was 21% (9/42) in the +P group and 41% (20/49) in the +S group (difference -19%; (95% confidence interval (CI) [-38, -1], p = 0.07) and prevalence of no hearing loss was 36% (15/42) in the +P group and 16% (8/49) in the +S group (difference 19%; (95% CI [2, 37], p = 0.05). At subsequent time points, prevalence of moderate hearing loss remained lower in the +P group: differences -3%; (95% CI [-23, 18], p = 1.00 at age 24 months), -12%; (95% CI [-30, 6], p = 0.29 at age 30 months), and -9%; (95% CI [-23, 5], p = 0.25 at age 36 months). A major limitation was the small sample size, hence low power to reach statistical significance, thereby reducing confidence in the effect size.In this study, we observed a high prevalence and persistence of moderate (disabling) hearing loss throughout early childhood. We found a lower prevalence of moderate hearing loss and correspondingly higher prevalence of no hearing loss in the +P group, which may have substantial benefits for high-risk children, their families, and society, but warrant further investigation.ClinicalTrials.gov NCT01735084 and NCT01174849.
Affiliation
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
London School of Hygiene and Tropical Medicine, London, United Kingdom.
Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.
Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
Departments of International Health and Pediatrics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Center for Indigenous Health, Johns Hopkins University, Baltimore, Maryland, United States of America.
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
Department of Medicine, University of Sydney, Sydney, New South Wales, Australia.
Discipline of Child and Adolescent Health, University of Sydney, Sydney, New South Wales, Australia.
Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Division of Paediatrics and Child Health, University of Western Australia, Perth, Western Australia, Australia.
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Poche Centre for Indigenous Health, The University of Queensland, Brisbane, Queensland, Australia.
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia.
Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.
Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.
School of Allied Health, Faculty of Health Sciences, Curtin University, Perth, Western Australia, Australia.
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Women and Kids Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
London School of Hygiene and Tropical Medicine, London, United Kingdom.
Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.
Office of the Chief Health Officer, Queensland Health, Brisbane, Queensland, Australia.
School of Public Health, University of Sydney, Sydney, New South Wales, Australia.
Centre for Disease Control (CDC)-Environmental Health, Northern Territory Health, Darwin, Northern Territory, Australia.
Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.
Division of Paediatrics and Child Health, University of Western Australia, Perth, Western Australia, Australia.
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Australian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.
Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Paediatrics Department, Royal Darwin Hospital, Darwin, Northern Territory, Australia.
Citation
PLoS Med . 2024 Jun 3;21(6):e1004375. doi: 10.1371/journal.pmed.1004375. eCollection 2024 Jun.
ISSN
1549-1676
OrcId
0000-0002-4638-8392
0000-0001-9841-2692
0000-0001-5808-7450
0000-0001-7677-510X
0000-0001-9505-7197
0000-0002-0004-6274
0000-0002-1734-5414
0000-0001-7216-8097
0000-0001-6086-6285
0000-0003-4670-0638
0000-0002-1182-9792
0000-0002-1331-3706
Pubmed ID
https://pubmed.ncbi.nlm.nih.gov/38829821/?otool=iaurydwlib
Link
MESH subject
Humans
Infant
Pneumococcal Vaccines
Hearing Loss
Australia
Child, Preschool
Female
Male
Otitis Media
Prevalence
Vaccines, Conjugate
Pneumococcal Infections
Immunization Schedule
Title
Hearing loss in Australian First Nations children at 6-monthly assessments from age 12 to 36 months: Secondary outcomes from randomised controlled trials of novel pneumococcal conjugate vaccine schedules.
Type of document
Journal Article
Entity Type
Publication

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