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Original Article | Volume 10 Issue 2 (July-December, 2024) | Pages 715 - 723
Newborn Hearing Screening Outcomes and Follow-up in Postnatal and Neonatal Intensive Care Units: A Hospital-Based Observational Study in West Bengal, India
1
Assistant Professor, Department of Paediatrics, Santiniketan Medical College, Bolpur, West Bengal.
Under a Creative Commons license
Open Access
Received
Sept. 24, 2024
Revised
Oct. 4, 2024
Accepted
Oct. 16, 2024
Published
Oct. 28, 2024
Abstract
Background: Newborn hearing screening enables early identification of infants requiring further audiological assessment. However, screening outcomes depend on appropriate testing, repeat screening, and completion of diagnostic follow-up.Objective:To describe newborn hearing-screening outcomes and follow-up and compare selected clinical characteristics and initial screening outcomes between postnatal-ward and neonatal intensive care unit (NICU) newborns.Methods:This observational study included 166 newborns screened at Santiniketan Medical College and Hospital, Bolpur, West Bengal, between March and August 2024. The cohort comprised 136 postnatal-ward and 30 NICU newborns. Clinical characteristics, initial otoacoustic emission (OAE) screening results, repeat-screening completion and outcomes, and available diagnostic assessments were analysed.Results:The median gestational age was 38 weeks and median birth weight was 2,950 g. Initial OAE screening was passed by 151 newborns (91.0%), while 15 (9.0%) were referred. Referral rates were 7.4% in the postnatal ward and 16.7% in the NICU (p = 0.151). Of 15 referred newborns, 13 (86.7%) completed repeat screening; nine passed and four (30.8% of those completing repeat screening) had persistent referrals. Three of the four newborns with persistent referrals completed diagnostic assessment, identifying one case of hearing impairment.Conclusion:Initial screening was passed by most newborns, but incomplete follow-up limited diagnostic interpretation. Completion of repeat screening and diagnostic assessment is essential for evaluating programme outcomes.
Keywords
INTRODUCTION
Newborn hearing screening is an important component of early childhood healthcare because congenital and early-onset hearing impairment can affect speech, language acquisition, communication, and subsequent developmental progress.1 Hearing impairment may be present at birth without obvious clinical signs, making identification based solely on parental concerns or routine clinical examination insufficient.2 Early detection provides an opportunity for timely audiological evaluation, family counselling, and appropriate intervention during a critical period of language development. Consequently, newborn hearing screening has become an important element of comprehensive neonatal care.3 Evidence from systematic reviews indicates that universal newborn hearing screening is associated with earlier identification of permanent childhood hearing loss and earlier initiation of intervention. Yoshinaga-Itano et al. (2021) reported that universal screening was associated with earlier identification, amplification, and early-intervention services, with better language and literacy outcomes reported in the included studies.4 The development of objective physiological screening techniques has made early hearing assessment more feasible. Otoacoustic emissions (OAE) are acoustic responses generated by the cochlea following auditory stimulation.5 Their presence provides information about cochlear outer hair-cell function, allowing rapid, non-invasive assessment without requiring a behavioural response from the newborn. Automated auditory brainstem response (AABR) assesses neural responses to sound and provides complementary information about the auditory pathway.6 Both techniques have established roles in neonatal hearing-screening programs, although their appropriate use depends on the clinical population and the screening protocol.7 The Joint Committee on Infant Hearing (2019)3 emphasized the importance of systematic screening linked to diagnostic evaluation and early intervention, rather than treating screening as an isolated procedure. The World Health Organization (2021)8 highlighted the importance of integrating hearing screening with diagnostic and management services. Such programs require coordinated pathways extending from initial screening to repeat testing, definitive assessment, and intervention. A screening result classified as refer indicates that further assessment is necessary; it does not establish a diagnosis of hearing impairment. Temporary middle-ear conditions, residual material in the external auditory canal, environmental noise, and technical factors may influence initial screening results. Repeat screening can therefore help identify newborns who require further investigation while reducing unnecessary diagnostic referrals.8 The screening pathway also needs to account for differences between healthy newborns and infants requiring intensive care. Prematurity, low birthweight, severe neonatal illness, and certain infections or medication exposures may increase concern about auditory dysfunction.1 Some infants admitted to neonatal intensive care units (NICUs) may have auditory neuropathy spectrum disorder, in which conventional OAE findings alone may not adequately characterize auditory function. The Indian Academy of Pediatrics consensus statement recommended ABR screening for NICU infants and a defined follow-up pathway for newborns who did not pass screening.9 These recommendations highlight the importance of selecting an appropriate screening protocol for the clinical setting. The relevance of clinical setting is supported by the systematic review and meta-analysis by Butcher et al. (2019), which included approximately 1.8 million screened infants. The pooled prevalence of permanent childhood hearing loss detected through universal screening was 1.1 per 1,000 newborns and was 6.9 times higher among infants admitted to the NICU. The authors also noted that differences in screening protocols and population characteristics affected comparisons between programmes.10 Implementing newborn hearing screening in India involves additional practical considerations. Kumar and Mohapatra (2011)11 described the status and implementation challenges of newborn hearing-screening programs in India. Programme implementation depends on trained personnel, suitable equipment, coordination between neonatal and audiology services, parental awareness, and accessible follow-up. The effectiveness of screening is limited when newborns with abnormal results do not complete subsequent assessment. Screening completion, repeat-screening attendance, and diagnostic follow-up are therefore important measures of programme performance.6 In a systematic review and meta-analysis, Edmond et al. (2022) found that universal newborn hearing screening was associated with earlier identification of permanent bilateral hearing loss, although the certainty of evidence was low or very low for several outcomes.12 Hospital-based studies have contributed to understanding the practical implementation of neonatal hearing screening in different Indian settings. Upadhyay et al. (2022)13 reported the outcomes of a universal neonatal hearing-screening programme at a tertiary-care centre, illustrating the use of staged screening and diagnostic follow-up in an Indian hospital setting. Such studies demonstrate the importance of distinguishing initial referral from persistent referral and confirmed hearing impairment. Differences in study populations, screening protocols, follow-up duration, and diagnostic coverage must be considered when interpreting reported outcomes. Against this background, the present study evaluated newborn hearing-screening outcomes at a hospital in West Bengal. It examined the demographic and clinical characteristics of newborns admitted to the postnatal ward and neonatal intensive care unit (NICU), initial otoacoustic emission (OAE) screening outcomes, repeat-screening completion and results, and subsequent diagnostic follow-up. Selected clinical characteristics and initial screening outcomes were compared between the two care settings. The study aimed to describe the screening outcomes and follow-up patterns observed in this hospital-based cohort.
MATERIALS AND METHODS
Study Design and Setting A prospective observational study was conducted at Santiniketan Medical College and Hospital, Bolpur, West Bengal, India. The study included newborns admitted to the postnatal ward and neonatal intensive care unit (NICU). Initial otoacoustic emission (OAE) screening outcomes, repeat-screening completion, persistent referral, and subsequent diagnostic assessment outcomes were evaluated. Study Duration The study period extended from March to August 2024, covering six months. Newborn screening records and subsequent repeat-screening and diagnostic follow-up outcomes were considered for the analysis. The study involved newborns and therefore required appropriate institutional ethical oversight and parental or legally authorized representative consent, as applicable. The Declaration of Helsinki provided the ethical framework for the protection of participants.14 Confidentiality of newborn information was maintained, and study records were restricted to variables relevant to the research objectives. Sample Size Calculation The target sample size was 166 newborns. The initial screening referral rate was used as the basis for the planning calculation. Assuming an expected referral proportion of 10%, a 95% confidence level, and an absolute precision of 5%, the sample size was estimated using the formula: [ n=\frac{Z^2p(1-p)}{d^2} ] where n represented the required sample size, Z was 1.96, p was the anticipated referral proportion of 0.10, and d was the absolute precision of 0.05. The calculated sample size was approximately 138 newborns. An additional 20% was added to account for anticipated incomplete follow-up, resulting in a target sample size of approximately 166 newborns. Study Population The study included 166 newborns, comprising 136 from the postnatal ward and 30 from the NICU. Sex, gestational age, birthweight, care setting, initial screening outcome, repeat-screening completion and outcome, and diagnostic follow-up outcomes were recorded where available. Gestational age below 37 completed weeks defined preterm birth, and birthweight below 2,500 g defined low birth weight. Screening Outcomes and Study Variables The primary outcome was persistent referral among newborns who completed repeat screening following an initial referral. Secondary outcomes included the initial OAE screening pass and referral rates, repeat-screening completion, repeat-screening outcomes, completion of diagnostic assessment, and available diagnostic outcomes. The variables analyzed included sex, gestational age, birthweight, care setting, initial screening classification, repeat-screening completion and result, diagnostic-assessment completion, and diagnostic outcome where available. Initial screening results were classified at the participant level: a newborn was considered to have passed when both ears passed, while a referral in either ear resulted in an overall referral classification. Newborns with incomplete repeat screening were classified separately and were not considered to have passed. Otoacoustic Emission Screening and Follow-up Otoacoustic emissions are low-level acoustic signals generated by the cochlea in response to auditory stimulation. OAE screening was used in Indian neonatal hearing-screening programs as a rapid, non-invasive method for identifying newborns requiring further assessment. Upadhyay et al (2022)13 described a two-stage protocol using distortion-product otoacoustic emissions (DPOAE), followed by auditory brainstem response (ABR) assessment for newborns who did not pass screening. For OAE testing, a suitable probe was placed in the external auditory canal to deliver acoustic stimuli and record cochlear emissions. Testing was performed in a quiet environment, with the newborn settled and the probe appropriately positioned. A screening device's automated algorithm was used to classify the examination as a pass or referral according to its configured criteria. A referral indicated the need for further assessment and did not, by itself, establish hearing impairment. Initial OAE screening outcomes were recorded for all 166 newborns. Of these, 151 passed and 15 were referred for repeat screening. The initial screening referral rates were compared between the postnatal ward and NICU groups. Newborns with an initial referral were considered for repeat screening. Of the 15 referred newborns, 13 completed repeat screening and two had incomplete follow-up. Among the 13 newborns with valid repeat results, nine passed and four had persistent referrals. Repeat-screening completion was calculated using all initially referred newborns as the denominator, whereas repeat pass and persistent-referral proportions were calculated using only newborns with valid repeat results. Diagnostic Assessment Diagnostic assessment was advised for the four newborns with persistent referral. Three completed the diagnostic assessment, while one did not complete follow-up. Attendance at the diagnostic referral and completion of the diagnostic assessment were recorded separately. Among the three completed assessments, the recorded outcomes were hearing impairment confirmed, no hearing impairment identified, and further assessment required, with one newborn in each category. Diagnostic outcomes were analyzed descriptively. Sensitivity, specificity, positive predictive value, negative predictive value, and population prevalence of hearing impairment were not calculated because diagnostic reference assessment was not completed for the entire screened cohort. Statistical Analysis Categorical variables were summarised as frequencies and percentages. Continuous variables were summarised as medians and interquartile ranges, with ranges reported where applicable. Gestational age and birthweight were compared between the postnatal ward and NICU groups using the Mann–Whitney U test. Fisher's exact test was used to compare prematurity, low birth weight, and initial screening referral between the two groups. The association between sex and care setting was assessed using the chi-square test. The persistent-referral proportion among newborns completing repeat screening was reported with a 95% Wilson confidence interval. Repeat-screening outcomes within the care-setting subgroups and diagnostic outcomes were summarised descriptively. All tests were two-sided, and a p value below 0.05 was considered statistically significant.
RESULTS
A total of 166 newborns were included in the analysis, comprising 136 (81.9%) from the postnatal ward and 30 (18.1%) from the neonatal intensive care unit (NICU). The overall median gestational age was 38 weeks, and the median birth weight was 2,950 g. Newborns in the NICU group had lower gestational ages and birth weights than those in the postnatal ward group. The overall demographic and clinical characteristics of the study population are summarized in Table 1. Table 1. Demographic and clinical characteristics of the study population Characteristic Overall (n = 166) Postnatal ward (n = 136) NICU (n = 30) Gestational age, weeks, median (IQR) 38 (37–39) 39 (38–40) 34 (33–37) Gestational age range, weeks 30–41 35–41 30–40 Birth weight, g, median (IQR) 2,950 (2,650–3,288) 3,050 (2,800–3,350) 2,225 (1,950–2,912) Birth weight range, g 900–3,950 1,950–3,950 900–3,650 Preterm birth (<37 weeks), n (%) 33 (19.9) 11 (8.1) 22 (73.3) Low birth weight (<2,500 g), n (%) 31 (18.7) 12 (8.8) 19 (63.3) Data are presented as median (interquartile range [IQR]), range, or number (percentage), as appropriate. Males accounted for 86 (51.8%) newborns, while 80 (48.2%) were females. The sex distribution was comparable between the postnatal ward and NICU groups, with no statistically significant difference (χ² test, p = 0.699). The sex distribution across the two screening groups is presented in Table 2. Table 2. Sex distribution according to screening group Sex Postnatal ward (n = 136) NICU (n = 30) Overall (n = 166) Male, n (%) 69 (50.7) 17 (56.7) 86 (51.8) Female, n (%) 67 (49.3) 13 (43.3) 80 (48.2) p-value 0.699 — — The p-value was calculated using the chi-square test. Gestational age and birth weight differed significantly between the two groups. The NICU group had a lower median gestational age than the postnatal ward group (34 versus 39 weeks; Mann–Whitney U test, p < 0.001) and a lower median birth weight (2,225 versus 3,050 g; p < 0.001). Preterm birth and low birth weight were also substantially more frequent among NICU newborns. These comparisons are detailed in Table 3. Table 3. Comparison of gestational age and birth weight between screening groups Variable Postnatal ward (n = 136) NICU (n = 30) Statistical test p-value Gestational age, weeks, median (IQR) 39 (38–40) 34 (33–37) Mann–Whitney U <0.001 Birth weight, g, median (IQR) 3,050 (2,800–3,350) 2,225 (1,950–2,912) Mann–Whitney U <0.001 Preterm birth, n (%) 11 (8.1) 22 (73.3) Fisher’s exact test <0.001 Low birth weight, n (%) 12 (8.8) 19 (63.3) Fisher’s exact test <0.001 Preterm birth was defined as gestational age <37 weeks; low birth weight was defined as birth weight <2,500 g. Percentages are calculated within each screening group. At the initial otoacoustic emission (OAE) screening, 151 (91.0%) newborns passed, while 15 (9.0%) were referred for repeat screening. The referral proportion was 7.4% in the postnatal ward group and 16.7% in the NICU group. Although the referral proportion was higher among NICU newborns, the difference was not statistically significant (Fisher’s exact test, p = 0.151). Initial screening outcomes are presented in Table 4. Table 4. Initial OAE screening outcomes according to screening group Screening group Pass, n (%) Refer, n (%) Total, n p-value Postnatal ward 126 (92.6) 10 (7.4) 136 0.151 NICU 25 (83.3) 5 (16.7) 30 — Overall 151 (91.0) 15 (9.0) 166 — The p-value compares initial referral proportions between the postnatal ward and NICU groups using Fisher’s exact test. A participant was classified as pass only when both ears passed; referral was recorded if either ear referred. Of the 15 newborns referred at the initial screen, 13 (86.7%) completed repeat OAE screening, while two (13.3%) did not complete the repeat assessment. Among the 13 newborns with valid repeat results, nine (69.2%) passed and four (30.8%) continued to have a referral result. The distinction between screening completion and repeat-screening outcome is shown in Table 5. Table 5. Completion and outcomes of repeat OAE screening Repeat-screening outcome n Percentage Among all initially referred newborns (n = 15) Repeat screening completed 13 86.7 Repeat screening not completed 2 13.3 Among newborns with a valid repeat result (n = 13) Passed on repeat screening 9 69.2 Persistent referral 4 30.8 Completion percentages use 15 initially referred newborns as the denominator. Repeat pass and persistent-referral percentages use the 13 newborns with valid repeat results as the denominator. Incomplete repeat screening was not classified as pass or referral. Among the 13 newborns who completed repeat screening, the proportion with persistent referral was 30.8% (4/13; Wilson 95% confidence interval [CI], 12.7–57.6%). In the postnatal ward group, two of eight newborns with completed repeat screening had persistent referral, compared with two of five in the NICU group. These subgroup findings are presented in Table 6; the small numbers limit meaningful statistical comparison between groups. Table 6. Repeat OAE outcomes according to initial screening group Screening group Initially referred, n Repeat screening completed, n Repeat pass, n (%) Persistent referral, n (%) Postnatal ward 10 8 6 (75.0) 2 (25.0) NICU 5 5 3 (60.0) 2 (40.0) Overall 15 13 9 (69.2) 4 (30.8) Repeat outcome percentages are calculated among newborns with completed repeat screening within each group. No inferential comparison is presented because of the small subgroup counts. Diagnostic assessment was advised for the four newborns with persistent referral. Three (75.0%) attended and completed the diagnostic assessment, while one (25.0%) did not complete it. Diagnostic follow-up completion is summarized in Table 7. Table 7. Completion of diagnostic follow-up Diagnostic follow-up step n Denominator Percentage Diagnostic assessment advised 4 4 persistent referrals — Diagnostic referral attended 3 4 advised 75.0 Diagnostic assessment completed 3 4 advised 75.0 Diagnostic assessment not completed 1 4 advised 25.0 Diagnostic follow-up percentages are calculated only among newborns for whom diagnostic assessment was advised. Among the three completed diagnostic assessments, hearing impairment was confirmed in one newborn, no hearing impairment was identified in one, and further assessment was required in one. Each outcome therefore accounted for one-third of completed assessments. These findings are summarized in Table 8. Given the small number of completed diagnostic assessments and incomplete assessment of the overall cohort, these outcomes should be interpreted descriptively and cannot establish the prevalence of hearing impairment. Table 8. Outcomes of completed diagnostic assessments Diagnostic outcome n Percentage of completed assessments (n = 3) Hearing impairment confirmed 1 33.3 No hearing impairment identified 1 33.3 Further assessment required 1 33.3 Total 3 100.0 Diagnostic outcomes are reported descriptively. The number of completed assessments is insufficient to estimate population-level hearing-impairment prevalence or diagnostic accuracy.
DISCUSSION
This study assessed newborn hearing screening outcomes and follow-up among 166 newborns at a tertiary-care hospital in Bolpur, West Bengal. Initial OAE screening showed a pass rate of 91.0% and a referral rate of 9.0%. The referral proportion was higher among NICU newborns (16.7%) than postnatal-ward newborns (7.4%), but the difference was not statistically significant (p = 0.151). The NICU group had a substantially higher proportion of preterm newborns (73.3% vs. 8.1%) and newborns with low birth weight (63.3% vs. 8.8%). Gestational age and birth weight were also significantly lower in the NICU group. These differences indicate distinct clinical profiles; however, this study did not establish whether prematurity or low birth weight independently influenced screening outcomes. Previous Indian studies have reported higher hearing-impairment rates among at-risk newborns than among well or low-risk newborns. Kapadia et al. (2022)15 reported an overall incidence of 5.41 per 1,000 newborns, with a higher incidence in the at-risk group. Similarly, Parab et al. (2018)16 reported a hearing-loss prevalence of 10.69 per 1,000 among high-risk newborns compared with 1.689 per 1,000 among well babies. Higher incidence among at-risk newborns was also reported by Rai and Thakur (2013)17 and Bhalot et al. (2023)18. These findings support the importance of considering clinical risk when planning screening and follow-up, although confirmed hearing-loss rates cannot be directly compared with initial referral rates in the present study. Screening outcomes have varied across Indian programs. Upadhyay et al. (2022)13 reported an OAE referral rate of 1.53%, follow-up completion of 94.12%, and hearing-impairment incidence of 7 per 1,000 newborns using a two-stage screening protocol. Satish et al. (2019)19 screened 26,487 newborns using a four-stage protocol and reported 19 cases of hearing impairment. These studies illustrate different approaches to screening and diagnostic confirmation. However, differences in population, protocol, and follow-up prevent direct comparison of their diagnostic outcomes with the present study's initial referral rate. At the institutional level, Kumar and Mohapatra (2011)11 reported that universal newborn hearing screening was conducted by 38.09% of responding medical colleges and 80% of responding speech and hearing centres. Their low questionnaire response rate of 16.75% limits generalizability, but the findings demonstrate variation in reported screening practices across responding institutions. Nelson et al. (2008)7 found that universal newborn hearing screening was associated with earlier referral, diagnosis, and treatment; some evidence also suggested improved receptive-language outcomes at school age. Together, these findings emphasize the importance of linking screening to timely diagnostic assessment and intervention. Of the 15 newborns referred after initial screening, 13 completed repeat screening (86.7%). Nine of these 13 newborns passed the repeat screen (69.2%), while four (30.8%) had persistent referral results. Among the eight postnatal-ward newborns who completed repeat screening, six passed; among the five NICU newborns, three passed. These small subgroup counts support descriptive reporting but not reliable inferential comparison. The findings highlight the distinction between an initial screening referral and confirmed hearing impairment. Indian Academy of Pediatrics consensus statement recommended repeat screening after an initial failure and ABR audiometry following persistent failure and specifically recommends ABR screening for infants admitted to intensive care.9 The Joint Committee on Infant Hearing (2019)3 likewise emphasized access to screening, evaluation, and intervention through an effective early hearing detection and intervention system. Of the four newborns with persistent referral results, three completed diagnostic assessment. One was reported to have confirmed hearing impairment, one had no impairment identified, and one required further assessment. Because diagnostic assessment was completed in only three newborns, these findings cannot establish the prevalence of hearing impairment in the screened population. Sensitivity, specificity, positive predictive value, and negative predictive value also cannot be reliably estimated from the available data. The screening method used for NICU newborns must be verified against the original records before the manuscript is finalized. The Results report OAE screening outcomes for both groups, whereas Indian Academy of Pediatrics consensus statement recommends ABR screening for NICU infants. The manuscript must accurately reflect the method actually performed rather than assume that the study followed the recommended ABR pathway. Strengths and limitations A strength of this study is its reporting of initial screening, repeat-screening completion, persistent referrals, and available diagnostic outcomes. However, the single-centre design and small sample limit generalizability. Incomplete follow-up and the completion of diagnostic assessment by only three newborns with persistent referral results prevent reliable estimation of hearing-loss prevalence or screening accuracy. The small subgroup sizes also limit comparisons between NICU and postnatal-ward newborns. Overall, this study provides a local description of newborn hearing-screening outcomes and follow-up. Its findings highlight the importance of completing repeat screening and diagnostic assessment and accurately documenting the screening pathway. Larger studies with more complete diagnostic follow-up are needed to estimate hearing-loss prevalence and evaluate screening performance.
CONCLUSION
This study describes newborn hearing-screening outcomes and follow-up at a tertiary-care hospital in West Bengal. Although 91.0% of newborns passed initial otoacoustic emission screening, 15 required further assessment. Four of the 13 newborns completing repeat screening had persistent referrals, and diagnostic assessment confirmed hearing impairment in one of the three newborns assessed. Incomplete follow-up limited estimation of hearing-impairment prevalence and screening accuracy. The findings emphasize the importance of completing repeat screening and diagnostic assessment after referral. Larger studies with comprehensive follow-up are needed to establish population-level outcomes and evaluate newborn hearing-screening pathways across different neonatal care settings.
REFERENCES
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