scholarly journals Oral prednisolone for acute otitis media in children: protocol of a pilot randomised, open-label, controlled study (OPAL study)

2018 ◽  
Vol 4 (1) ◽  
Author(s):  
Respati W. Ranakusuma ◽  
Amanda R. McCullough ◽  
Eka D. Safitri ◽  
Yupitri Pitoyo ◽  
Widyaningsih ◽  
...  
Keyword(s):  
Otitis Media ◽  
Acute Otitis Media ◽  
Oral Prednisolone ◽  
Controlled Study ◽  
Open Label

scholarly journals Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study)

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Respati W. Ranakusuma ◽  
Amanda R. McCullough ◽  
Eka D. Safitri ◽  
Yupitri Pitoyo ◽  
Widyaningsih Widyaningsih ◽  
...  
Keyword(s):  
Pilot Study ◽  
Sample Size ◽  
Otitis Media ◽  
Middle Ear ◽  
Acute Otitis Media ◽  
Trial Registration ◽  
Controlled Study ◽  
Antibiotic Prescribing ◽  
Open Label ◽  
Oral Corticosteroids

Abstract Background Acute otitis media (AOM) is associated with high antibiotic prescribing rates. Antibiotics are somewhat effective in improving pain and middle ear effusion (MEE); however, they have unfavourable effects. Alternative treatments, such as corticosteroids as anti-inflammatory agents, are needed. Evidence for the efficacy of these remains inconclusive. We conducted a pilot study to test feasibility of a proposed large-scale randomised controlled trial (RCT) to assess the efficacy of corticosteroids for AOM. Methods We conducted a pilot, pragmatic, parallel, open-label RCT of oral corticosteroids for paediatric AOM in primary and secondary/tertiary care centres in Indonesia. Children aged 6 months–12 years with AOM were randomised to either prednisolone or control (1:1). Physicians were blinded to allocation. Our objectives were to test the feasibility of our full RCT procedures and design, and assess the mechanistic effect of corticosteroids, using tympanometry, in suppressing middle ear inflammation by reducing MEE. Results We screened 512 children; 62 (38%) of 161 eligible children were randomised and 60 were analysed for the primary clinical outcome. All study procedures were completed successfully by healthcare personnel and parents/caregivers, despite time constraints and high workload. All eligible, consenting children were appropriately randomised. One child did not take the medication and four received additional oral corticosteroids. Our revised sample size calculation verified 444 children are needed for the full RCT. Oral corticosteroids did not have any discernible effects on MEE resolution and duration. There was no correlation between pain or other symptoms and MEE change. However, prednisolone may reduce pain intensity at day 3 (Visual Analogue Scale mean difference − 7.4 mm, 95% confidence interval (CI) − 13.4 to − 1.3, p = 0.018), but cause drowsiness (relative risk (RR) 1.8, 95% CI 1.1 to 2.8, p = 0.016). Tympanometry curves at day 7 may be improved (RR 1.8, 95% CI 1.0 to 2.9). We cannot yet confirm these as effects of corticosteroids due to insufficient sample size in this pilot study. Conclusions It is feasible to conduct a large, pragmatic RCT of corticosteroids for paediatric AOM in Indonesia. Although oral corticosteroids may reduce pain and improve tympanometry curves, it requires an adequately powered clinical trial to confirm this. Trial registration Study registry number: ACTRN12618000049279. Name of registry: the Australian New Zealand Clinical Trials Registry (ANZCTR). Date of registration: 16 January 2018.

Myringotomy in acute otitis media. A controlled study

JAMA ◽  
1966 ◽  
Vol 197 (11) ◽  
pp. 849-853 ◽  
Author(s):  
O. F. Roddey
Keyword(s):  
Otitis Media ◽  
Acute Otitis Media ◽  
Controlled Study

scholarly journals Otitis media outcomes of a combined 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine and 13-valent pneumococcal conjugate vaccine schedule at 1-2-4-6 months: PREVIX_COMBO, a 3-arm randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Amanda Jane Leach ◽  
Edward Kim Mulholland ◽  
Mathuram Santosham ◽  
Paul John Torzillo ◽  
Peter McIntyre ◽  
...  
Keyword(s):  
Haemophilus Influenzae ◽  
Otitis Media ◽  
Conjugate Vaccine ◽  
Otitis Media With Effusion ◽  
Controlled Trial ◽  
Acute Otitis Media ◽  
Trial Registration ◽  
Open Label ◽  
Suppurative Otitis Media ◽  
Link Type

Abstract Background Aboriginal children living in Australian remote communities are at high risk of early and persistent otitis media, hearing loss, and social disadvantage. Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) are the primary pathogens. We compared otitis media outcomes in infants randomised to either a combination of Synflorix™ (PHiD-CV10, with protein D of NTHi) and Prevenar13™ (PCV13, with 3, 6A, and 19A), with recommended schedules for each vaccine alone. We previously reported superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months. Methods In an open-label superiority trial, we randomised (1:1:1) Aboriginal infants at 28 to 38 days of age, to either Prevenar13™ (P) at 2–4-6 months (_PPP), Synflorix™ (S) at 2–4-6 months (_SSS), or Synflorix™ at 1–2-4 months plus Prevenar13™ at 6 months (SSSP). Ears were assessed using tympanometry at 1 and 2 months, combined with otoscopy at 4, 6, and 7 months. A worst ear diagnosis was made for each child visit according to a severity hierarchy of normal, otitis media with effusion (OME), acute otitis media without perforation (AOMwoP), AOM with perforation (AOMwiP), and chronic suppurative otitis media (CSOM). Results Between September 2011 and September 2017, 425 infants were allocated to _PPP(143), _SSS(141) or SSSP(141). Ear assessments were successful in 96% scheduled visits. At 7 months prevalence of any OM was 91, 86, and 90% in the _PPP, _SSS, and SSSP groups, respectively. There were no significant differences in prevalence of any form of otitis media between vaccine groups at any age. Combined group prevalence of any OM was 43, 57, 82, 87, and 89% at 1, 2, 4, 6, and 7 months of age, respectively. Of 388 infants with ear assessments at 4, 6 and 7 months, 277 (71.4%) had OM that met criteria for specialist referral; rAOM, pOME, or CSOM. Conclusions Despite superior broader overall immunogenicity of the combination schedule at 7 months, and early superiority of PHiD-CV10 compared to PCV13 at 4 months, there were no significant differences in prevalence of otitis media nor healthy ears throughout the first months of life. Trial registration ACTRN12610000544077 registered 06/07/2010 and ClinicalTrials.govNCT01174849 registered 04/08/2010.

An Open-Label, Double Tympanocentesis Study of Levofloxacin Therapy in Children With, or at High Risk for, Recurrent or Persistent Acute Otitis Media

2006 ◽  
Vol 25 (12) ◽  
pp. 1102-1109 ◽  
Author(s):  
Adriano Arguedas ◽  
Ron Dagan ◽  
Michael Pichichero ◽  
Eugene Leibovitz ◽  
Jeffery Blumer ◽  
...  
Keyword(s):  
High Risk ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Open Label

scholarly journals Video Discharge Instructions for Acute Otitis Media in Children: A Randomized Controlled Open‐label Trial

2019 ◽  
Vol 26 (12) ◽  
pp. 1326-1335 ◽  
Author(s):  
Sheena Belisle ◽  
Andrei Dobrin ◽  
Sharlene Elsie ◽  
Samina Ali ◽  
Shaily Brahmbhatt ◽  
...  
Keyword(s):  
Otitis Media ◽  
Acute Otitis Media ◽  
Discharge Instructions ◽  
Open Label ◽  
Randomized Controlled ◽  
Open Label Trial

A Multicenter, Open Label, Double Tympanocentesis Study of High Dose Cefdinir in Children With Acute Otitis Media at High Risk of Persistent or Recurrent Infection

2006 ◽  
Vol 25 (3) ◽  
pp. 211-218 ◽  
Author(s):  
Adriano Arguedas ◽  
Ron Dagan ◽  
Eugene Leibovitz ◽  
Alejandro Hoberman ◽  
Michael Pichichero ◽  
...  
Keyword(s):  
High Risk ◽  
Otitis Media ◽  
Acute Otitis Media ◽  
Recurrent Infection ◽  
High Dose ◽  
Open Label

scholarly journals Specific probiotics in reducing the risk of acute infections in infancy – a randomised, double-blind, placebo-controlled study

2008 ◽  
Vol 101 (11) ◽  
pp. 1722-1726 ◽  
Author(s):  
Samuli Rautava ◽  
Seppo Salminen ◽  
Erika Isolauri
Keyword(s):  
Otitis Media ◽  
Respiratory Infections ◽  
Acute Otitis Media ◽  
Lactobacillus Rhamnosus ◽  
Controlled Study ◽  
First Year ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Recurrent Respiratory Infections ◽  
First Year Of Life

A randomised, double-blind, placebo-controlled study was conducted to determine whether probiotics might be effective in reducing the risk of infections in infancy. Infants requiring formula before the age of 2 months were recruited from community well-baby clinics. Infant formula supplemented with the probioticsLactobacillus rhamnosusGG andBifidobacterium lactisBb-12 or placebo was administered daily until the age of 12 months. Incidence of early infections (before the age of 7 months) and incidence of recurrent (three or more) infections during the first year of life were recorded as the main outcome measures of the study. During the first 7 months of life, seven out of thirty-two (22 %) infants receiving probiotics and twenty out of forty (50 %) infants receiving placebo experienced acute otitis media (risk ratio (RR) 0·44 (95 % CI 0·21, 0·90);P = 0·014) and antibiotics were prescribed for ten out of thirty-two (31 %) infants receiving probiotics and twenty-four out of forty (60 %) infants receiving placebo (RR 0·52 (95 % CI 0·29, 0·92);P = 0·015). During the first year of life, nine out of thirty-two (28 %) infants receiving probiotics and twenty-two out of forty (55 %) infants receiving placebo encountered recurrent respiratory infections (RR 0·51 (95 % CI 0·27, 0·95);P = 0·022). These data suggest that probiotics may offer a safe means of reducing the risk of early acute otitis media and antibiotic use and the risk of recurrent respiratory infections during the first year of life. Further clinical trials are warranted.

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