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INTRODUCTION: Gestational malaria is related to very bad perinatal outcomes and antimalarial drugs used during pregnancy can be ototoxic to the fetus. OBJECTIVE: To determine the prevalence of hearing loss in newborns of mothers who had malaria and treated with antimalarial drugs during pregnancy. CONCLUSION: The prevalence of hearing loss in newborns of mothers who had vivax malaria and used chloroquine during pregnancy was 3%.
Hearing is one of the noblest of senses since its main function is related to the acquisition and development of oral language1,2.
Hearing impairment is considered to be highly disabling due to its consequences on human communication, as well as its impact on cognitive and psychosocial development and the development of oral and written language6. The occurrence of malaria during pregnancy, particularly in the last trimester, can be determinant for infant health, with implications for fetal or neonatal development. In Brazil, the occurrence of malaria during pregnancy is common in endemic areas such as the states of Roraima, Rondonia, Para, Mato Grosso, Acre, and Amazonas11.
In the municipality of Porto Velho (RO) malaria in pregnancy has been shown to be related to poor perinatal outcomes such as preterm birth, extremely low, very low and low birth weight, and death13. In another study, 12 children born to mothers who had been treated with antimalarial drugs during pregnancy had sensorineural hearing loss. In view of the above considerations, the objective of the present study was to verify the prevalence of hearing loss in newborns of mothers who had malaria and treated with antimalarial drugs during pregnancy and to characterize the audiologic findings according to newborn gestational age, birth weight, risk factors for hearing loss, type of malaria infection, type of medication used, and gestational period of malaria occurrence and drug treatment. A cross-sectional, quantitative, descriptive-analytical, observational study was conducted using a multifactorial approach.
The number of women with malaria during pregnancy, who were admitted to the hospital during the period of data collection, was taken as the basis for sample size calculation. The study flow chart contains data regarding infant gender, date of birth, type of malaria infection, gestational period of infection, type of medications used, and presence of risk factors for hearing loss established by the Joint Committee on Infant Hearing (JCIH)16 and by the Multiprofessional Committee on Auditory Health (Comite Multiprofissional em Saude Auditiva - COMUSA)17. The puerperal women were contacted by the researcher while still in the maternity ward in order to investigate the occurrence of malaria during pregnancy.
After signing the informed consent, the interview was conducted with the puerperal participants. The tests were performed in a quiet room in the presence of the mother or an accompanying person. The step of diagnostic evaluation was performed at the clinic responsible for the NHS program after hospital discharge. After this procedure, the diagnostic ABR test was performed to quantify and identify hearing impairment. Newborns who have had the electrophysiological threshold for tone bursts at 2000 Hz with bilateral 30 dBHL were considered patients with normal hearing and remained in auditory monitoring the NHS program up to 24 months. For data analysis, the distribution of the occurrence of the type of infection and of the gestational period when malaria occurred was first determined, followed by the determination of the distribution of the type of antimalarial medication used for treatment and the gestational period during which the medication was administered, using the test for equality of two proportions. As for the risk factors for hearing loss found in association with the occurrence of malaria and the use of antimalarial drugs in pregnancy, the use of ototoxic medication by the newborn was the most frequent risk factor and this finding was significant when compared to the other risk factors, except for extracorporeal oxygenation (Table 4). No relationship was observed between the NHS result and type of medication, risk factors for hearing loss, gestational period of infection, use of medication, or type of malaria infection (Table 5).
The prevalence of hearing loss in our sample was 3% (n = 1), taking into account that two newborns did not undergo the audiological diagnosis.
In the present study, Plasmodium vivax was the most frequent species found in women during pregnancy, as also reported in other studies10,13,19-21. The antimalarial drug most frequently used was chloroquine as recommended by the Brazilian Ministry of Health for the treatment of vivax malaria in pregnancy25. In a study conducted in Porto Velho (RO) on 66 newborns of mothers who used antimalarial drugs during pregnancy, three infants were born to mothers who were treated with primaquine and one was diagnosed with unilateral profound hearing loss21. As for the gestational period during which the antimalarial drug was used, no difference was observed between trimesters. In the present study, the number of "pass" results in NHS was higher than the number of "failed" results, in agreement with other studies conducted in the same municipality14,21. Two of the four newborns who failed the screening test and who were referred to the clinic responsible for the program for diagnostic evaluation did not attend the assessment.
The socioeconomic conditions of the families who participate in the NHS program and the lack of knowledge of the consequences of hearing loss are some factors that could explain the evasion in the population studied, considering that the results of the study showed a low educational level of the women who mainly had incomplete elementary school. No relationship was found between the NHS results and the variables weight at birth and gestational age, despite having knowledge that gestational malaria is related to very bad perinatal outcomes, including low birth weight13 which could have enhanced the occurrence of hearing loss in newborns.
The most frequent risk factor for hearing loss associated with malaria and antimalarial drug use in pregnancy was the use of ototoxic medication by the newborn, in agreement with other studies21,34. Urinary tract infection is common among young women and is the most frequent complication during pregnancy30, especially among primiparous women35. The high level of bilirubin requiring blood transfusion was a risk factor for hearing loss in the infant diagnosed in the present study.
Elevated serum levels of bilirubin are considered toxic to the auditory pathways and central nervous system39.
Hyperbilirubinemia is one of the risk factors for neonatal deafness and for the development of encephalopathies39, since high levels of bilirubin can damage the auditory system at the peripheral level by altering cochlear hair cells and at the central level in the cochlear, olivary and inferior olivary nuclei41. In addition to blood transfusion, the infant was exposed to ototoxic medication (gentamicin) which can cause different degrees of damage, with cochlear hair cells damage being typical42.
The prevalence of hearing loss obtained in this study was more than evident in research conducted at the same hospital5, and the value obtained could have been higher, since two newborns did not undergo the audiological diagnosis.
In addition, it highlights the need for audiological follow these children in order to evaluate the occurrence of possible progressive alterations as demonstrated in another study which found 12 cases of hearing loss in children born to mothers who had malaria and used antimalarial drugs in pregnancy15.
The main limitation of the present study, which is common in studies involving populations recruited from NHS programs, is failure to attend a visit for diagnostic evaluation. The prevalence of hearing loss in newborns of mothers who had malaria and treated with antimalarial drugs during pregnancy was 3% (n = 1), the mothers' newborn diagnosed infected with Plasmodium vivax in the first trimester and treated with chloroquine throughout pregnancy. In addition, it was observed that there is no relationship between the NHS findings with the variables weight of the newborn at birth, gestational age, type of medication, IRDA, pregnancy infection, medication use and infection type. Paper submitted to the ITJ-SGP (Publishing Management System) on September 24, 2014; and accepted on July 6, 2015. Staffed by a multidisiplinary team of highly skilled nurses, substance misuse workers and peer support mentors.
If you think that you have a hearing loss and would like to talk about it with an experienced audiologist, please make an appointment for a full hearing assessment. There is no obligation to buy and you will have the opportunity to discuss your concerns, learn the exact nature of your loss and consider possible solutions. The following list of questions, while not exhaustive, will provide good indication of any hearing problems. If you have answered 'yes' to three or more of these questions, we recommend an in-depth hearing assessment with one of our hearing aid audiologists. All our dispensers place great emphasis on continual training and development, in order to retain professional status and keep abreast of the latest developments in hearing aid technology and practise.
Together with our support team, we are dedicated to providing and maintaining the highest professional and ethical standards of hearing care. Vicki Skeels RHAD FSHAA, managing director, began her career in Audiology in 1977 with the NHS in Colchester.
Debbie Lawrence RHAD FSHAA, joined us in January 2014, but has an association with Vicki and the industry dating back 20 years.
Hearing aids are more than mere amplifiers, they are complex digital devices and in order to for them to reach their life-changing potential they must be fitted by an expert. Hearing aids purchased online cannot be programmed properly to suit your specific hearing loss, and any money you save upfront will be lost with interest when the aids inevitably need repairing or adjusting to function properly. We stock a range of hearing aid accessories and cleaning items for the vital maintenance of your hearing aid, along with all types of hearing aid batteries. Products such as Oticon's ConnectLine range increase your control over your aids, enabling programme shifts and device synchronisation at the touch of a button.
We also advise on noise protection products, such as sonic valve ear defenders for military or sporting use, along with custom-made swim plugs and specialist musician ear plugs. Hearing aid technology has improved greatly over the years - today’s digital instruments offer more natural hearing and are smaller, more efficient, and more comfortable than ever before. Advanced devices such as Phonak's extended-wear Lyric can be placed so deeply in the ear that they are completely invisible. At The Hearing Care Centre, we offer an extensive range of hearing aids from all the leading manufacturers.
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8.    You should see links to ‘London Health Fulltext’ below each result where the full text of the article is available. 9.    You may need to login with Athens (NHS username and password) to access full-text articles. The trial was undertaken at Nottingham Hearing Biomedical Research Unit (BRU) and the Ear Institute at University College London and was sponsored by Nottingham University Hospitals NHS Trust.
This study systematically evaluated a new, targeted, sound-based device for tinnitus using a two-centre randomised controlled trial conducted at NIHR Nottingham Hearing BRU and UCL Ear Institute, London.
Nottingham University Hospitals NHS Trust and The Tinnitus Clinic were discussing a new trial on Acoustic CR Neuromodulation. Prevalence of hearing loss in newborns of mothers who had malaria and were treated with antimalaric drugs in pregnancy. All underwent neonatal hearing screening with otoacoustic emissions combined with automatic auditory brainstem response. Auditory sensory deprivation interferes with the ability to interpret speech sounds and results in economic and educational disadvantages2.


The malaria parasites can easily cross the placental barrier or are transmitted through maternal-fetal transfusion9. The latest survey regarding the proportion of positive slides in pregnant women from the municipality of Porto Velho, Rondonia (RO), was performed in 2010 and revealed 331 cases of malaria in rural and urban areas, including 48 cases caused by P.
In a study conducted in the same municipality, two newborns of mothers who had malaria and used antimalarial drugs in pregnancy were diagnosed with mild unilateral sensorineural hearing loss14. This hearing loss was irreversible in eight of these children, with seven presenting profound hearing loss. All puerperal women received information about the objectives and methodology of the study and agreed to the procedures by signing the free informed consent form.
Transient otoacoustic emissions (TOAE) and automated auditory brainstem responses (AABR) were measured with an Accuscreen instrument (Madsen). The results obtained during hearing screening and diagnostic evaluation were recorded on the study flow chart.
Women who confirmed the presence of the disease were invited to participate in the study and received information about the objective and importance of the study and the procedures used.
When necessary, the records of the women and their newborns were accessed to complement the information if the mother could not answer the question or was in doubt. For electrophysiological assessment of hearing, the infants remained lying in the crib or on the mother's lap during natural non-sedated sleep. For this test, a probe microphone with a latex bulb was introduced into the external auditory canal of the newborn and emissions were evoked with a broadband click at an intensity of 80 dB SPL. For this test, the skin in the areas of electrode placement (high forehead and mastoids) was cleaned to permit adequate impedance. Diagnostic evaluation consisted of tympanometry, diagnostic TOAE, diagnostic ABR, and an appointment with the otorhinolaryngologist. The NHS results were correlated with birth weight and gestational age by analysis of variance (ANOVA).
Two of the four infants that failed the NHS and that were referred to the clinic responsible for the program for further tests abandoned the program.
The audiologic findings of this newborn included the bilateral presence of TOAE; absence of waves I, III and V at 90 dB in the click ABR test accompanied by the presence of cochlear microphonism, and tympanometry revealed normal mobility of the tympano-ossicular system.
In addition to the fact that the mother had malaria and made use of antimalarial drugs during pregnancy, the newborn was exposed to ototoxic medication (gentamicin) for 9 days and required exchange transfusion due to hyperbilirubinemia. This finding was statistically significant when compared to the occurrence of the disease in the third trimester. The use of primaquine is contraindicated for the treatment of pregnant women, irrespective of the Plasmodium species involved and gestational period, and during the breast-feeding period until 6 months25.
This infant had no associated risk factor for hearing loss, suggesting that the medication administered possibly caused or potentiated the occurrence of hearing impairment. However, the frequency of antimalarial drug use was higher in the second trimester, although the frequency of malaria occurrence was higher in the first trimester of gestation. Despite an attempt to perform an active search, as routinely done, the mothers could not be contacted by telephone.
The infant can be infected at the time of delivery, through hematogenic dissemination, or postpartum36.
Neonatal hyperbilirubinemia is toxic to the auditory pathways and central nervous system29 and newborns submitted to exchange transfusion are considered to be at high risk for the development of auditory neuropathy38.
In the latter, the yellow color is more intense in the subthalamic nucleus and globus pallidus and may be present in the hippocampus, geniculate bodies, vestibular, cochlear and oculomotor nuclei, cerebellum and spinal cord40.
Other studies have demonstrated a close relationship between hearing impairment and hyperbilirubinemia5,39,40.
A close relationship between hearing impairment and use of ototoxic medication has been reported for newborns30,43,44. The chance of these newborns have hearing loss is high, since the NHS was performed with use of combined technical (OAE and AABR), which reduces the chance of false positives. Active search was necessary in various cases of the present sample, but contacting the participants was unsuccessful in two cases.
Audiological findings highlighted in this newborn indicate the presence of alteration in retrocochlear auditory pathways that are compatible with the auditory neuropathy spectrum. The IRDA, concomitant with malaria and the use of antimalarial drugs during pregnancy, most common was the use of ototoxic medication by the newborn, but hyperbilirubinemia with exchange transfusion was one of the risk indicators found in newborns diagnosed with hearing loss. Birchwood House offers a unique blend of clinical and theraputic support to help each individual to acheive his or her recovery goal, and find solutions to substance use. We even offer trial periods on some of our hearing aids, so you can discover just how much you may have been missing out on.
Other causes include hereditary factors, prolonged exposure to noise exceeding 85 decibels (the equivalent to heavy road traffic), illness, accidents or even some medications. A proper hearing test will determine the nature of your loss, whether you require further medical opinion and whether a hearing aid can help. It will only take a few minutes and will test how clearly you can hear in different levels of background noise.
There is no substitute for a proper hearing test carried out by a trained hearing aid audiologist.
She subsequently worked in hearing research at Nottingham University and as Head of Audiology at Northampton General Hospital. She is a Registered Hearing Aid Dispenser and has previously served on The Hearing Aid Council, the former regulatory body for hearing aid dispensers. After a long period on the management team of a regional hearing aid chain, Richard is pleased to have returned to a smaller, more personalised practice.
She followed her audiology training together with Richard, qualifying as an audiologist in 2000, and has been working for the independent sector ever since. The Earol spray pump delivers a measured dose of fine, pharmaceutical grade olive oil into your ear, so there’s no more mess.
They no longer just make all sounds louder, but can differentiate between various sounds and present them in different ways.
Merging the cosmetic advantages of ITE devices with the technological possibilities of BTE devices. These come in a variety of styles and fittings, from near-invisible ‘in the canal’ customised instruments to ultra-small ‘behind the ear’ models, some less than 1 inch long. In 2012, The Tinnitus Clinic Ltd contracted a 100 participant clinical trial (randomised controlled double blind) to establish whether or not this treatment works under properly controlled conditions.
We quantified patient benefit using a range of different validated outcome measures, but the main outcome was a change in self-reported tinnitus distress measured by a questionnaire. Review of the trial by independent auditors, however, concluded that there had been deviations from trial protocol and lack of compliance with the manufacturer’s fitting instructions. All the results have been uploaded onto ClinicalTrials.gov (NCT01541969) and will soon be publicly available. Independent tinnitus clinical trials of this kind are currently relatively uncommon within the UK. Why did it take nearly a year from when the results were expected to decide that the results were not reliable? The independent audit and an internal review by the Sponsor, Nottingham University Hospitals NHS Trust, both agreed that there was a lack of scientific robustness across trial results.
Those who failed were referred to audiological diagnosis with evoked otoacoustic emissions and brainstem auditory evoked potential associated with tympanometry (1000 Hz). Furthermore, hearing is essential for interpersonal relationships and relationships with the environment2. Any type of hearing loss can compromise language, learning, cognitive development and social inclusion of the child7, and it is therefore important that hearing impairment is detected as early as possible. A study demonstrated that pregnant women infected with Plasmodium falciparum present clinical and laboratory alterations, such as altered hemoglobin, hematocrit, creatinine, urea, bilirubin, and glucose.
The treatment indicated for the mothers was chloroquine, chloroquine combined with quinine, and quinine combined with Fansidar.
The study was conducted at the maternity unit of a referral hospital for high-risk pregnancies in the capital of Rondonia. The following eligibility criteria were established for formation of the sample: newborns of women who had malaria in pregnancy, newborns participating in the NHS Program, and newborns born or hospitalized in the maternity unit of the state referral hospital for high-risk pregnancies in Porto Velho (RO) whose mothers agreed to participate in the study by signing the free informed consent form. Adopting a level of significance of 95% and a sampling error of 6%, the estimated sample size was 35 newborns. Personal data for subsequent contact were also recorded in case it was necessary to schedule a day and time for a new assessment during both the screening and diagnostic evaluation phases. Mothers who agreed to participate in the study signed two copies of the free informed consent form, one was given to them and the other was kept by the responsible researcher. Infants presenting normal outer hair cell function obtained a "pass" result, which occurs automatically.
Tympanometry, which investigates tympano-ossicular system function, excluding possible middle ear alterations, was performed using a 1000-Hz probe tone since it is more sensitive in identifying these alterations in infants aged 0 to 4 months18. The frequency of risk factors for hearing loss was analyzed by the test for equality of two proportions and the NHS results were correlated with variables such as type of malaria infection, gestational period when malaria occurred, type of antimalarial agent and gestational period when it was used.
The otorhinolaryngologist requested imaging exams to evaluate possible involvement of the central auditory pathway. The Plasmodium species contracted by the mother during the first trimester of gestation was the vivax type. This result differs from that reported in another study21 conducted in the same city, in which the distribution of malaria was homogenous across the three trimesters.
In contrast, the World Health Organization recommends the use of primaquine under medical supervision26.


In the present study, the participants reported the use of antimalarial drugs in more than one trimester, as recommended by the Brazilian Ministry of Health that indicate chloroquine as chemoprophylaxis against P.
In this respect, it is important for the mother to have a minimum educational level, financial resources and harmony in social and marital relationships to seek the best health measures for her child31.
Authors said that the lower the birth weight, the greater the chances of failure in the NHS32,33, which was not observed in this study. This result highlights the need to develop other studies with this population, but in larger samples. In addition, the rapid discharge of the participants, which is a major obstacle of NHS programs, may have contributed to the small sample size. O conhecimento, a valorizacao da triagem auditiva neonatal e a intervencao precoce da perda auditiva.
Hearing aids fitting process in users that are seen in a federal public institution: part I--results and implications with the amplification device. Avaliacao eletrofisiologica de recem-nascidos de maes que fizeram uso de antimalaricos na gestacao. Estudio de los efectos ototoxicos en 725 pacientes tratados con antimalaricos en el hospital central de Maputo (Mozambique). Year 2007 position statement: Principles and guidelines for early hearing detection and intervention programs. Accoustic immitance measures in infants with 226 and 1000 hz probes: correlation with otoacoustic emissions and otoscopy examination. Retardo no crescimento intrauterino, baixo peso ao nascer e prematuridade em recem-nascidos de gravidas com malaria, na Colombia.
Achados audiologicos de recem-nascidos de maes que fizeram uso de antimalaricos no periodo gestacional [Resumo n. Fatores de riscos associados a transmissao de malaria humana, em areas de ressacas, nos bairros Novo Horizonte e Zerao, Macapa, Amapa, Brasil. Determinants of intermittent preventive treatment of malaria during pregnancy (IPTp) utilization in a rural town in Western Nigeria. Indicadores de risco para perda auditiva em neonatos e lactentes atendidos em um programa de triagem auditiva neonatal. Triagem auditiva em um hospital publico de Belo Horizonte, Minas Gerais, Brasil: deficiencia auditiva e seus fatores de risco em neonatos e lactantes. Analysis of transient otoacoustic emissions and brainstem evoked auditory potentials in neonates with hyperbilirubinemia. Perda auditiva neonatal associada a hiperbilirrubinemia por deficiencia de glicose-6-fosfato desidrogenase: relato de caso.
Sequelas auditivas e neuropsicomotoras em recem-nascidos de termo ictericos tratados pelos metodos convencionais.
Comparacao das alteracoes auditivas em recem-nascidos da UTI neonatal expostos e nao expostos a antibioticos. Medico do Setor de Saude Auditiva e Implante Coclear Universidade de Brasilia - UnB, Professor Substituto Otorrinolaringologia Universidade de Brasilia - UnB. Professor e orientador do programa de pos-graduacao em Ciencias da Saude e Ciencias Medicas da Universidade de Brasilia - UnB.
The majority of hearing loss is ‘sensorineural’, namely irreversible damage to the sound-conducting hair cells of the inner ear. Vicki gained her private qualifications in 1988 and practised independently off Harley Street and for a leading manufacturer in New Zealand, before returning to Colchester and establishing The Hearing Care Centre in 1998.
With his passion and genuine care for people, we are delighted to have him as part of the team.
Debbie is enjoying learning more about the wide variety of hearing instruments we offer, to find the best solutions for her clients.
Users can also focus on specific things like speech, with background noise now more easily overcome.
New open-ear designs incorporate the tiniest of components, while the very latest aids function seamlessly with other wireless devices like mobile phones, Bluetooth connections and televisions. None of these factors were individually critical, but, when considered together, there was concern that the results of the study could not be regarded as scientifically robust.
A number of articles are in various stages of submission to peer-reviewed journals and these report information gathered during the study that will inform the design of future trials. There has been significant learning both from this trial and the auditors’ findings that will be taken into future trials for tinnitus devices. Our experience from the trial has led the Nottingham Hearing BRU and Nottingham University Hospitals Trust to make changes in how our clinical trials are set up, conducted and monitored and we have also increased levels of staff training and supervision. The device could be made available on the NHS if Clinical Commissioning Groups or Hospitals chose to commission it. Such reviews also inevitably take some time to complete a detailed investigation of the trial. Data were obtained through interviews with the mothers' and analyzing the patient chart and the newborn, and underwent to statistical tests analysis of variance, equality of two proportions and Chi-square test (p = 0.05). Therefore, hearing impairment during the first years of life of a child can interfere with the acquisition and development of speech and language3-5.
Newborn hearing screening (NHS) continues to be the only strategy able to detect early hearing alterations that could interfere with the quality of life of an individual5,8. At this hospital, an NHS Program is provided by a private clinic accredited by the National Health System (Sistema Unico de Saude - SUS), where diagnosis and intervention are performed. Excluded were infants born to mothers who were unable to report the occurrence and gestational period of malaria infection and infants born in other maternity units who were therefore not seen at the NHS service of the maternity unit where the study was conducted. It was not possible to include more subjects because the period scheduled was not sufficient to continue the process. Disposable insert earphones and electrodes were used for the two instruments, as well as disposable gloves, gauze and 70% alcohol to clean the infant's face and for fixation of the electrodes. Risk factors were analyzed by the chi-squared test in order to determine the relationship between the findings and the variables mentioned. Antimalarial drug use was more frequent in the second trimester of gestation, but most participants reported use of the medication in more than one trimester (Table 2).
The results of these exams indicated the presence of bilateral impairment of the retrocochlear auditory pathways, findings compatible with the spectrum of auditory neuropathy. This divergence may be explained by the difference in the period of data collection between the two studies, since the present study was conducted during the dry season (June to November), with the occurrence of malaria being related to climatic22-24 and environmental factors and an increase in transmission being observed at the end of the rainy season22. However, this indication has become rare as observed in the present study and other studies in which pregnant women had malaria during pregnancy and were treated with chloroquine14,27. No relationship between the NHS results and gestational age agrees with evidenced by other researchers29. Even if NHS is performed daily, including weekends and holidays, the large number of births per day in the maternity unit where the study was conducted leads to early discharge and the consequent loss of some newborns.
Ary Pinheiro (Porto Velho- RO) causados pela malaria durante a gestacao no periodo de 2001 a 2003 em usuarias do SUS.
The degree of loss can range from mild to profound, and most people with hearing difficulties can benefit from using hearing instruments. It is therefore with regret that all the parties have concluded that the results of the trial cannot be published with confidence. The limitations of the study set out in the above reports include inadequate specification of the Clinical Trial Protocol, particularly with regard to (i) device fitting, (ii) tolerance for pitch matching shifts and (iii) monitoring of research audiologists after training. We are confident that future trials in tinnitus in Nottingham will conducted to a very high standard and that there will be no repetition of the difficulties experienced during the trial of Acoustic CR® Neuromodulation. Cochlear damage initially involves the outer hair cells, generally affecting high-frequency hearing. The final sample consisted of 35 mothers who had malaria and used antimalarial drugs in pregnancy and their children.
Subjects who needed to complete the diagnostic phase were referred to the clinic responsible for the NHS program.
Infants who failed the test were directly referred for diagnostic evaluation, a procedure adopted by the program to prevent abandonment by the mothers, in addition to the fact that ABR is not affected by vernix which would justify retesting within 15 days.
Infection occurred more frequently in the first trimester of gestation and this result was significant when compared to the third trimester (Table 1). Continuing to suffer with hearing loss can significantly affect our social life and our relationships, and often leads to a feeling of isolation. Regrettably, these shortcomings in the trial set-up mean that the device was not tested according to manufacturer’s protocol.
Also, some of the data collected during the recruitment phase for the trial will provide useful information and this will be published to inform the design of future trials. Nottingham University Hospitals NHS Trust has disclosed to the Brook Henderson Group a set of recommended actions relating to what additional knowledge one would need prior to developing a new trial including feasibility research necessary to inform trial design , irrespective of whether Nottingham University Hospitals NHS Trust sponsors that trial or not. The results of the trial cannot therefore be regarded as a robust test of the efficacy of Acoustic CR Neuromodulation as currently used, and do not contribute to the scientific literature and debate in the way we, and our patients, would have wished. Nottingham Hearing BRU, Nottingham University Hospitals NHS Trust and The Tinnitus Clinic are very grateful for the time and effort of the participants of the original trial. The study did not meet the criteria for publication as a clinical trial, but has provided important information on the scientific basis of clinical trials in tinnitus which will be published shortly.



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