Background

Hearing loss is the most common birth defect and occurs more frequently than other conditions. It is 100 times more prevalent than phenylketonuria and 10 times more prevalent than hypothyroidism; 5 times more frequent than Down syndrome and 25 times more than spina bifida. Permanent hearing loss in children occurs in 1-3 out of every 1000 newborns, and in 2-4 out of every 100 newborns discharged in neonatal intensive care units. The economic damage from congenital deafness per patient is estimated to be $ 1 million over a lifetime [1]. The importance of the health problem that deafness implies in childhood has been valued by national and international scientific organizations and societies. Neonatal Universal Hearing Screening is a valuable strategy for detecting newborns with permanent hearing damage, using both EOA (Otoacoustic Emissions) and PEATC (Brainstem Auditory Evoked Potentials); the latter with higher sensitivity (97-100%) and higher specificity (96-98%), which is why they are considered the gold standard for hearing loss detection. However, this method is complex and expensive [2]. The incidence of bilateral sensorineural deafness varies according to different studies from 0.5-1 per 1,000 to 1-3 per 1,000 newborns [1]. This incidence tends to increase in the event of presenting risk factors that predispose to the diagnosis of hearing loss in the newborn born. Hearing loss is a problem of great importance in childhood due to the consequences it can have on the intellectual and social development of the child if it is not identified and treated early. The timely detection of this diagnosis is a cornerstone to improve the prognosis and adequate auditory and linguistic development of the patient because the longer the detection of the problem is delayed, the more difficult it will be for the patient to recover completely. Various authors have established the period before six months of age for the timely diagnosis of hearing loss in newborns as well as the start of their treatment [3]. To carry out systematic screening studies in newborns with risk factors, it is necessary to know if the sensitivity and specificity of this test can be reproduced in our setting. In addition, very varied percentages have been reported in terms of sensitivity and specificity, ranging from 67% to 100%, depending on the study, which leads us to wonder if the incidence of RN who are diagnosed with hearing loss may appear variations if these they present the risk factors established by the American Academy of Pediatrics, and if so, put an emphasis on the analysis of these patients to avoid delaying diagnosis and treatment, giving them the opportunity to fully develop as an individual.

Study design: The present investigation was carried out through a prospective study with a descriptive, cross-sectional, quasi-experimental and analytical design [4].

Study Place or Site: The study population was all the neonates who presented risk factors for neonatal hearing loss, established by the American Association of Pediatrics and who were born in the Regional Hospital of High Specialty of Ciudad Victoria "Bicentennial 2010" (HRAEV) and at the General Hospital “Dr. Norberto Treviño Zapata”of Cd. Victoria, in the period from March 01 to September 30, 2018

Sampling technique: Probabilistic type, simple random.

Place and site of the study: Regional Hospital of High Specialty of Ciudad Victoria "Bicentennial 2010". General Hospital of Ciudad Victoria “Dr. Norberto Treviño Zapata”

Inclusion criteria (risk factors) [5] : Family history of inherited sensorineural hearing loss, TORCH infections in utero: Toxoplasmosis, Others, (Syphilis), Rubeola, Cytomegalovirus, Herpes virus, Cranial facial and ear anomalies, Stigmas or other data associated with dysmorphological syndrome that includes neuroseonsorial problems or conductive hearing loss (Genetic factor), Hyperbilirubinemia > 16 mg / dl or that required exsanguine-transfusion, Birth weight <1500 grams, APGAR <3 after 5 minutes or <6 after 10 minutes, Stay in the Neonatal Intensive Care Unit> 48 hours, Mechanical ventilation, especially for more than 10 days, Ototoxic Medicines: Including aminoglycosides, diuretics or the combination thereof, Diagnosis of neonatal meningitis, Sepsis in the newborn (Early or late), Parental consent to participate in the study, Newborns of both sexes, Newborns obtained by dystocic delivery or cesarean and Newborns with gasometric confirmed perinatal asphyxia data.

Process

Once the purpose of the procedure had been explained and the informed consent of the parents had been signed (APPENDIX 1), otoscopy was performed on newborns with risk factors who attended the General Hospital Dr. Norberto Trevino Zapata and the Regional Hospital of High Specialty. Ciudad Victoria “Bicentennial 2010” during the months of March to October 2018. The otoscopy was performed by the Otorhinolaryngologist attached to the Hospital by means of an otoscope (Welch Allyn) to rule out the presence of earwax, debris and alterations in the tympanic membrane. Otoacoustic emissions were carried out in newborns with risk factors regardless of their age of extrauterine life in the preventive medicine office, preferably during physiological sleep in their mother's arms or in an examination bed with closed doors to decrease the ambient noise. After passing the previous procedure, the otoacoustic emissions test was carried out using a probe placed in the external ear canal of the ear and on the equipment screen we observed the start of the test when there is a hermetic seal between the walls of the ear canal and the olive of the team device. The frequencies of 2 kH_z, 3 kH_z and 4 kH_z were studied, these being the ones involved in the production of the language. At an intensity between 30 to 35 dB in each ear. At the end of the reading of the 3 frequencies on the screen it showed the word "happens" this means that the newborn had normal hearing or if the screen shows the word "under control", this meant that the newborn could have hearing loss greater than 35 dB. After the otoacoustic emissions, the study of auditory evoked potentials of the brain stem was performed with the BERAphone equipment. For this, the equipment is placed on the head (Figure 1) of the newborn, the first electrode is placed below the earlobe, the second electrode above the ear and the third electrode on the vertex (three fingers per above the ear in the midline). The impedance test will show if the electrodes are making good contact with the skin (signal), after this the measurement starts and a green light is observed on the BERA phone which indicates an adequate signal. On the computer screen, the recording of the electrical signal of the electrodes was observed in the form of a wave, reporting the following results, a green record and the word step (if you hear) (Figure 2), if the record shows a red color, the word refer (does not hear) in any of these cases is communicated to their relatives, if the result is to refer (does not hear) refers to the Otorhinolaryngologist, Audiologist and rehabilitation [6-8]. Once the information has been obtained, it is stored in a database developed in the SPSS version 21 program for windows to facilitate data analysis.

n= number of patients.

Source: SPSS V.20 database of the study: Sensitivity and Specificity of Otoacoustic Emissions in Newborns with risk factors.

Figure 1: Fagan nomogram of the entire population of newborns studied (n = 100).

n= number of patients.

Source: SPSS V.20 database of the study: Sensitivity and Specificity of Otoacoustic Emissions in Newborns with risk factors.

Figure 2: Curva ROC (Receiver Operating Characteristics), Sensibilidad y especificidad de ambos oídos, de la población de recién nacidos estudiada (n=100).

Statistical analysis

It is a study of diagnostic tests. Measures of central tendency, inferential statistics were calculated using contingency tables to determine sensitivity, specificity, positive and negative predictive value with a 95% CI. Cut-off points for sensitivity and specificity were established using the Receiver Operating Characteristics (ROC) curves. Likewise, the value of the area under the curve (AUC: Area under Curve) was determined to evaluate the global precision index [9,10]. To assess the validity of a test, the most important condition is to compare the test with the reference criteria (gold standard or gold standard) that is used as the truth criterion. The scheme used was the 2x2 table in which the possible results are crossed (positive or negative) of the diagnostic test that is evaluated against the truth as assessed by the reference criterion [9,10]. Contingency tables were prepared for the EOA test with which the sensitivity and specificity of the same were calculated, as well as the proportions of false positives (FP), false negatives (FN), and positive and negative predictive values, all of these Variables are represented in percentages and their interval for proportions was calculated using 95% reliability. Those patients detected as positive and negative by the BERA phone PEATC (gold test) were taken as true positive and true negative [9,10]. Devices that were used in the study. Otoacoustic Emissions: Interacoustics A / S 5500 Middiefart, Denmark. Otoread, version 3.20, determines transient otoacoustic emissions from 500H_z to 4kH_z, also generates otoacoustic emissions, distortion products with 2 pure tones at frequencies f1 and f2, its range is from 1kH_z to 12kH_z. The resulting emissions of interest is the distortion product tone at frequency 2 f1-f2. Equipment certified by ISO 13485: 20003 and accepted by the FDA. BERAphone MB 11: Stimulus type CE-Chirp stimulus, Stimulus speed: 93 / sec. Stimulus levels 35dB HL, Stimulus Click. Stimulus Speed 14 / sec. Stimulus level 0 70 dB HL, Transducers: Dynamic transducer (8 ohms) built into the MAICO MB11 measurement probe, EEG Amplifier Amplification: 87 dB (23,000 times) [8]. Mac Pro Book computer: Mac OS High Sierra, Intel Core i5 dual-core 2.3 GHz (Turbo Boost up to 3.6 GHz) with 64 MB of eDRAM, integrated 128 GB PCIe-based SSD.

Ethical considerations

This study was conducted in accordance with the Declaration of Helsinki (1964) amended in October 2000. This research project was submitted to the Ethics and Research Committee of the Regional Hospital of High Specialty of Ciudad Victoria "Bicentennial 2010" with the number of I register PT-008-2018 (dated June 18, 2018) being Dr. Arani Casillas Ramirez and the Ethics and Research Committee of the General Hospital of Ciudad Victoria “Dr. Norberto Treviño Zapata with registration number HG-CB-0063-18 (dated May 21, 2018), being the chairman of the committee Dr. Hector Leopoldo Diaz Guzman Verastgui. 

100 newborns with risk factors who entered the neonatal intensive care unit, corresponding to 200 ears, were studied. 37 patients (37%) were female and 63 (63%) male. The distribution of the population (n = 100) studied according to weight, the mean we obtained was 3061.47 grams and the standard deviation ± 878.069. The gestational age of newborns ranged from a mean of 37.65 weeks to a standard deviation ± 3.08169. According to the age in days in which the otoacoustic emissions were taken, we detected an average of 14.90 days with a standard deviation of 20.71 days, with a minimum of one days and a maximum of 120 days. When confronting both EOA and PEATC tests (BERAphone) we present in the 2x2 table or contingency table the results that we obtained in (Table 1).

Table 1: Contingency table or 2x2 table of Otoacoustic Emissions (OE) vs BERAphone of all ears and all patients n = 100.

OE: Otoacoustic Emissions.

BERAphone: Auditory Evoked Potentials of the Brainstem.

n= number of patients.

Source: SPSS V.20 database of the study: Sensitivity and Specificity of Otoacoustic Emissions in Newborns with risk factors.

The outlined results (EOA and PEATC) in a simple and simple way can be seen in the Fagan nomogram, with which which we confirmed a post test result of 71% for positive test and for negative test a post test result of 2% figure 1. The precision of the tests (EOA and PEATC) of both ears can be seen in the Receiver Operating Characteristics (ROC) curve, showing a sensitivity of 71.43% and a specificity of 97.85% and the Area under Curve (AUC) with a value of 0.846 figure 2. When reviewing the right ear and left ear separately, we see that the sensitivity and specificity have different results, as well as the AUC values, (Figure 3, 4). (Table 2) presents the final results of all diagnostic tests, sensitivity, specificity, positive and negative likelihood ratio, positive and negative predictive value, and test precision.

Table 2: Results of the diagnostic tests of the newborn population studied (n = 100).

CI= Confidence interval

n= number of patients.

Source: SPSS V.20 database of the study: Sensitivity and Specificity of Otoacoustic Emissions in Newborns with risk factors.

n= number of patients.

Source: SPSS V.20 database of the study: Sensitivity and Specificity of Otoacoustic Emissions in Newborns with risk factors.

Figure 3: ROC curve (Receiver Operating Characteristics), Sensitivity and Specificity of the left ear, of the newborn population studied (n = 100).

n= number of patients.

Fuente: SPSS V.20 database of the study: Sensitivity and Specificity of Otoacoustic Emissions in Newborns with risk factors.

Figure 4: ROC curve (Receiver Operating Characteristics), Sensitivity and Specificity of the right ear, of the newborn population studied (n = 100).

The proposal of this study was to confirm the high sensitivity and specificity of otoacoustic emissions in newborns with risk factors hospitalized in the neonatal intensive care unit. According to the results of our research, we detected regular sensitivity and high specificity to detect hearing loss or deafness. Therefore, they are not sufficiently discriminatory as a screening test in the newborn, since in these types of patients, early identifications are required to start diagnosis, treatment and early rehabilitation, which is why more than 90% sensitivity and 98% specificity are required [11,12]. With regard to the precision of diagnostic tests, the revised concepts are of special importance today in evidence-based medicine. Sensitivity and specificity descriptors can be identified as parameters intrinsic to diagnostic tests. Thus, they are less applicable to the specific clinical decision of a certain patient. On the other hand, the positive and negative predictive values ??are applicable to the algorithm of decision of the patients in a certain clinical situation; however they are dependent on the prevalence of the disease in the study population. The LR (likelihood ratio) are the most useful parameters to evaluate the performance of a diagnostic test, since they do not depend on prevalence and are applicable in the clinical decision making of the patient. They help us understand why it is not appropriate to carry out diagnostic tests on populations with a low pretest probability of the disease, with this we were able to confirm the ability of our test to detect hearing loss or deafness in newborns with risk factors, raising the suspicion of the disease and be feasible to implement in our daily practice, demonstrated in our results by means of the phase nomogram that facilitates the conversion of the pre-test probability into the post-test probability in a very simple way [13]. Gonzalez Amaro and Col. They studied a series of newborn patients with risk factors, and confirmatory tests with auditory evoked potentials of the brainstem, evaluating the performance of otoacoustic emissions, they detected 19 patients with hearing loss (14.17%), and observed a sensitivity very low (19.23%) and a very high specificity (98.74%) and a high false negative rate, they conclude that otoacoustic emissions are not recommended as the only test in screening for deafness in newborns with risk factors due to the high possibility of false negatives and great possibility of auditory neuropathy. When comparing results, a higher sensitivity was detected in the present study and with fewer false negatives, these very discrepant results may be secondary to the population reported by Gonzales Amaro and Col, being more susceptible and more predisposed to suffer neuropathy that compromises hearing and another factor that in its geographical area the prevalence of the disease is lower and different from our geographical area [14]. On the other hand, Charlene MT Robertson and Col, carried out a longitudinal study between the years 1974-2003, studied 1279 surviving extremely premature newborns with a gestational age of less than 28 weeks and a weight of less than 1250 grams, all of them were performed auditory evoked potentials of the brainstem by a multidisciplinary team to detect the presence of permanent deafness, defined moderate deafness 26-70 dB of hearing, and severe profound between 70 to 90 dB of hearing, find 40 patients with permanent deafness at 3 years and 24 with severe or profound, there were statistical significance among the risk factors such as: prolonged use of oxygen and gastrointestinal surgery. They conclude that permanent deafness has an important relationship with extreme prematurity and the use of prolonged supplemental oxygen is a marker to predict permanent hearing loss, and they confirm that they require more detail in their pathophysiological study to reduce the permanence of hearing loss. With these results we confirm that our study factors that have an association with small effect with hearing loss are: hyperbilirubinemia right ear, low apgar at 5 minutes and craniofacial malformations. With moderate effect: age in days or stay in the neonatal intensive care unit (right ear) and Apgar per minute. And with a strong association, weight, stay in the neonatal intensive care unit (left ear) and gestational age [11-15]. In our population, extremely premature patients were fewer than those studied by Robertson, and we also enrolled more late and term premature patients, possibly because of this factor we did not detect oxygen supplementation as a relevant factor; it is also confirmed that the ideal study in these patients to detect hearing loss is the follow-up with auditory evoked potentials of the brain stem which explores the entire auditory pathway to the cerebral cortex and not only at the level of external heair cells, therefore recommending PEATC in this type of population with risk factors [15]. In favor of this, the study by MC Carlos Fabian Martinez-Cruz. In the year 2000, at the National Institute of Perinatology in Mexico City, they studied a series of 40 children who were admitted to the neonatal intensive care unit, who were longitudinally followed up to 6 years of age. Studies were conducted of audiometry and auditory evoked potentials of the brain stem, preferably preterm infants with 32.4 weeks of gestational age and weight of 1557.5 gr were studied and their average stay in the unit was 22 days, they confirm that the most frequent associated factor was exposure to aminoglycoside (amikacin), observed in the results of the tonal audiometry bilateral hearing loss of the sensory-neural type, symmetrical with a severe degree with alterations in acute frequencies and concluded that in the newly preterm infants with an average weight of 1500 gr and a neonatal history complicated, prolonged exposure to aminoglycosides and hyperbilirubinemia are at high risk of hearing loss, amply justifying the audiological evaluation during the first 3 months of life. With this we can confirm that although in our research we did not detect an association between aminoglycosides and hyperbilirubinemia with hearing loss, precisely because of the population they studied since their group was only preterm infants of less than 1500 gr, which could have influenced our results since that the majority of our patients were term and with average stays of 14.90 days in the neonatal intensive care unit, however, gestational age and weight are factors that have an important association with hearing loss. In our research, we confirm the results of these authors. , the frequency of hearing loss was secondary to the adverse factors in the neonatal period in our environment and its repercussions on linguistic neurodevelopment for the identification of these babies and multidisciplinary follow-up, the auditory evoked potentials of the brainstem are particularly relevant in the study of this type of patients [16]. Renatin Ferreira and Col in 2003, studied otoacoustic emissions in newborns with hearing risk factors, 300 newborns, used the Starkey DP 2000 equipment, between the ages of 2 to 90 days, they detected altered EOA in 24% of the population and at discharge, auditory evoked potentials of the brainstem were taken, confirming alterations in 33 patients, which corresponds to 11%, which is why more than 50% of failures in otoacoustic emissions are confirmed to diagnose with certainty the auditory alterations in this type of Newborns also detected a high prevalence of risk factors in this population. Although the study relies on the performance of otoacoustic emissions to detect hearing loss, and not confirming with certainty and precision the sensitivity and specificity of this test, it detracts from its credibility, it was possible to confirm that otoacoustic emissions have a regular sensitivity and that they do not It can be used as a definitive test in the diagnosis of this type of patient with a high risk of hearing impairment, but it can be a complementary test with the auditory evoked potentials of the brain stem in its study and diagnosis before 6 months of age to start early. Its auditory treatment and rehabilitation [17]. Doctors Rado-Trevino and Alen - Ayca published in 2016 a study on the precision of otoacoustic emissions in 96 children from 0 to 4 years of age, comparing it against the auditory evoked potentials of the brainstem (PEATC), this at the National Institute of Rehabilitation in Lima, Peru, confirm sensitivity of 76% in the right ear and 65% in the left ear, they conclude that otoacoustic emissions do not represent a sufficiently discriminating alternative as a screening test in their population. Confirmed in the present study that otoacoustic emissions do not represent a sufficiently precise alternative as a screening test in children with risk factors, therefore, these patients should undergo PEATC to confirm our findings with certainty. With the above, it can be asserted that in this type of patients, due to having a history of risk of hearing loss, the most likely is that they will develop important neuropathic lesions, making timely detection and management essential to avoid auditory sequelae. And alterations in neurodevelopment [18]. As reported by Rado Trevino and Alen-Ayca [18], asymmetry in the response of both ears is confirmed in the results of otoacoustic emissions and auditory evoked potentials of the brainstem, although they detect greater sensitivity in the ROC curve for the right ear. For the left ear, for the above, there are some theories that try to explain it, namely: The asymmetry of otoacoustic emissions may be the product of the efferent system, it could be confirmed in our research based on the results of the PEATC averages by ear and the median value of otoacoustic emissions [19] for this there is an explanation that confirms it: The theory of cochlear asymmetric response depends on cerebral hemispheric specialization which was proposed by Douglas H Keefe in 2008 demonstrates that it does not there is a difference in the predominance of one or the other ear [20]. A, Suppiej and Collaborators in 2007, conducted an investigation comparing 3 tests: transient evoked otoacoustic emissions, automated auditory brain response, auditory evoked potentials of the brainstem, admitted newborns with risk factors to the neonatal intensive care unit, study 206 patients with auditory evoked brainstem potentials, 185 with otoacoustic emissions and 151 with automated auditory brain response, a sensitivity of 100% and specificity of 90.8% are detected for PEATC, for transitory otoacoustic emissions sensitivity of 100%, specificity of 78.2% , and for automated auditory brain response sensitivity of 88.9% and specificity of 70.6%, for all three tests the very low positive predictive value indicating that they are affected by prevalence and the three tests with a negative predictive value of 100%, we believe that such high values ??are greatly affected by the type risk factors, population studied, and methodological aspects; false positives were not compared in the study population with high ranges that exceed the recommendations of the Joint Committee on Infant Hearing JCIH, 2000, also the discrepancy with our results may be due to the fact that many of the patients were lost in the longitudinal study. That detracts from your results. According to its conclusion, it was observed that the most accurate study to identify patients with deafness and risk factors are the auditory evoked potentials of the brainstem, it is believed that more research studies are required [21]. The introduction of newborn hearing screening in developing countries has had a significant impact on Public health. This has caused these problems to be identified earlier, allowing rehabilitation and multidisciplinary management, which has an impact on the significant improvement of language, the ability to read and write, cognitive improvement and favorable academic results for children of all grades of hearing loss. Even so, severe degrees of deafness result in social and emotional disturbances. Monitoring of hearing and speech and language skills in children is indicated to identify progressive hearing disorders earlier and, finally, this is possible with the establishment of multidisciplinary programs where pediatricians, audiologists, otorhinolaryngologists intervene, teachers, geneticists, and family members [22].

According to the studies carried out by S. Chadha and A.S. Bais who demonstrate that irrigation factors in newborns can affect their hearing since they confirmed the delay in the latency of wave V and interval IV when conducting a study of auditory response of the brainstem, and confirm that all these patients have hypoxia in the cochlea and in the brain causing edema, degeneration and cellular necrosis, as well as prolongation of the interwave IV interval is indicative of sensorineural deafness and delayed neural conduction with the brain; reason of interest for the present investigation where it is intended to confirm the association between the presence of risk factors in the newborn with the presence or absence of hearing loss or deafness, where it detected, like them, that weight, gestational age and hospital stay, represent a strong association, but that no other study factor was altered, possibly other associated factors were not detected, because the type of population was different [23]. On the other hand, Wolff, carries out a meta-analysis where he compares the otoacoustic emissions with auditory evoked potentials of the brain stem, he finds a sensitivity that ranges from 50% to 100% and a specificity of 49% to 97% in his study In addition to comparing the sensitivity and specificity of both tests, its main objective was the early or late detection of hearing loss or deafness, which affects both language development and the social and emotional environment. They conclude that it was not possible to show advantages in language development if it is detected early in patients with risk factors, and there are parameters to be studied such as social aspects, quality of life and educational development. The discrepancy between sensitivity and specificity in most studies can be affected by the type of risk factor that affects the newborn, study population, and multidisciplinary team for its management and treatment [11]. Finally, JKY Yu and collaborators in Hong Kong in 2010, published a study that implemented universal hearing screening with combined tests such as otoacoustic emissions and auditory evoked potentials of the brainstem, especially studying the protocols of the population of newborns without risk factors. but they study the cost in hospitals, find feasibility for its implementation, since it plays an important role in the country, whether or not it is developed, to have sufficient resources for its implementation, although it does not contemplate the population of newborns with factors risk, deserves comment because they take 26 seconds to take the EOA and approximately 486 seconds for PEATC and affordable costs, although they recommend this implementation to detect patients with neurological hearing loss and auditory neuropathy, this delay could imply inconvenience for the patient and increase costs, this is why equipment such as The portable Beraphone (PEATC) is easy to use, fast, and affordable, easy to implement in hospital units and also has sensitivities of over 97% and specificity of close to 100%. Equipment implemented in our hospital unit, which helps early detection of this type of patients and especially newborns with established risk factors. This shows that in economically advanced countries they are concerned about this type of pathology with great impact on public health [24]. The limitations of our study are: The population size is small, and the association of risk factors with EOA will be presented in other research. With the results obtained, the sensitivity of the otoacoustic emissions is considered not very good, although in these cases in which the patient with hearing loss must be quickly identified, sensitivity of close to 100% is required, especially in patients who are from distant rural areas. Early identification and rehabilitation.

Otoacoustic emissions do not report very good sensitivity, therefore it is not a sufficiently discriminating alternative as a screening test in newborns with risk factors. So in these cases we recommend using portable brainstem auditory evoked potentials.

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