Reach Out and Read Literacy Program for Infants in Neonatal Intensive Care Unit: A Pre-Post Experimental Study

The elevated prevalence of linguistic delay in youngsters emphasizes the necessity to focus on strategies to improve language development, hence aimed to evaluate the effectiveness of Reach Out and Read (ROR) intervention on language development for infants admitted to neonatal intensive care unit (NICU) at a tertiary care hospital, in Belagavi, India. Eighteen infants admitted 7 or more days in NICU and had APGAR scores of more than 6 at the first and fifth minute after birth were recruited. Reach Out and Read was done for 6 months. At recruitment, corrected age 3 and 5 months’ general movement assessment (GMA) and at corrected age, 6 months’ Bayley Scale of Infant Development III (BSID III) language subtest was recorded. Wilcoxon matched paired test showed significant improvement (P = .0277; P = .0431) in GMA over time. Six-month parent delivered ROR intervention confirms its effectiveness in promoting general movement developmental trajectories of infants admitted to NICU.


Introduction
Language delay has been discovered to be common in a wide range of age groups and populations.According to studies, prevalence rates among children under the age of 5 range from 2.3% to 19%. 1 The risk of language development delay is higher in infants because of admission to NICU, prematurity, and low birth weight.Along with this, the offspring of mothers with gestational diabetes, pregnancy-induced hypertension, low socioeconomic status, and poor education are at a higher risk of language delay. 2 This NICU exposure in the early years of life due to several complications has been shown to have negative consequences on numerous aspects of a child's life when compared with other children.As a result, these circumstances have an immediate or later impact on the normal developmental trajectory of the child. 3Prematurely born infants (babies born alive before 37 weeks of gestation) and with low birth weight (babies born weighing less than 2500 g) are more likely to suffer intellectual and linguistic impairments before reaching schooling, according to research. 3ence, intervening at the earliest will aid in beneficial results among infants with numerous risks.The increased prevalence of language delay in youngsters underlines the urge to target language development in the early years to minimize the possibility of negative results and thus provide an optimum chance for improvement.
Reach out and Read is a research-based intervention for language development and home literacy. 4The most essential source of early linguistic input for children is their parents, who are also the key source of variety in that input. 5Human speech exposure during the neonatal period, particularly the voice of the mother, adds linguistic significance that can be critical for the brain's early wiring for language acquisition. 6lthough linguistic delay has a high prevalence, there is a paucity of literature on early interventions that can be provided to have a positive effect on the same.Hence the need to evaluate the effectiveness of ROR intervention on language development for infants in NICU using GMA and BSID III.

Subjects and Methods
Ethical clearance was obtained from the Ethical Committee of KLE Institute of Physiotherapy, Belagavi, Karnataka, India (KIPT/704/7-08-2020).The study was registered with the Clinical trial registry of India (CTRI/2021/10/037539).Infants admitted to NICU (Step down) of a tertiary care hospital in Belagavi city, Karnataka, India, were recruited from August 2021 to January 2022 for this pre-post experimental study.A sample size of 18 was calculated with a 5% significance level, 90% power, standard deviation (σ), and effect size (d) of 3. Medical records of the participants were referred, and recruitment of the infants was done by the principal investigator (Figure 1).The inclusion criteria were infants should be admitted to the tertiary care hospital NICU for 7 or more days, 6 mothers of infants should have a readability level equivalent to fourth to fifth grade, and parent voluntary willingness to participate.Infants having APGAR scores less than 6 at the first and fifth minute after birth, on any ventilatory support, alive but diagnosed with congenital anomalies and or visual loss by physicians and infants referred for any surgeries were excluded from the study.Written consent to participate and provide consent to the publication of the results was obtained from the parents of the infants recruited.At the time of recruitment, principal investigator noted the infant's birth characteristics, the mother's demographic details and recorded the baseline GMA (writhing movements) by taking a video as per the guidelines by the therapist who has a certification in GMA.The mothers were explained the ROR intervention 6 by the qualified and experienced pediatric physiotherapist, who is proficient in both English and vernacular language.Books and posters were available in the NICU Literacy room in English, Hindi, Marathi, and Kannada.Mothers were demonstrated the intervention and were asked to perform under supervision in the NICU Literacy room.Once the mothers were performing the intervention perfectly under supervision, they were asked to perform independently in the NICU Literacy room.Till the infant stayed in the NICU, mothers were encouraged to perform the intervention in the NICU literacy room.Further details of the ROR intervention are provided as a supplementary document.The procedure of performing the intervention at home was explained until all the queries' mothers had were resolved.During the time of discharge, mothers were given age-appropriate take-home books in the mother's preferred language (English, Hindi, Marathi, Kannada) to read to their infants.Emphasis on adherence to regular intervention at home was done through weekly phone calls and during the monthly visit to the high-risk baby clinic in tertiary care hospital.During each successive visit, a new age-appropriate take-home book was given to the mother.Between 3 and 5 months after term, GMA (fidgety movements [FMs]) were assessed.At corrected age 5 months 0 day to 6 months 30 days, postintervention outcomes such as GMA (Fidgety) and BSID III (Language Subtest) were evaluated by a BSID III certified and trained assessor.

Outcome Measures
Prechtl's General Movement Assessment [7][8][9] GMA is a qualitative instrument to evaluate the spontaneous motor repertoire in infants from preterm up to post-term age.It is an easily performable non-invasive method with the benefit of being cost-effective.General movements have a similar appearance from early fetal life until the end of the second month after term; from term age onward, they are called "writhing movements."At 6 to 9 weeks' post-term age, writhing movements gradually disappear and GMs of a fidgety character gradually emerge.Observable from 3 to 5 months after term, socalled "FMs" are tiny movements of the neck, trunk, and limbs in all directions and of variable acceleration.

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• Bayley Scales of Infant Development III. 10,11 The BSID III is an individually conducted tool that intends to evaluate the age-appropriate functioning of infants, toddlers, and young children aged between 1 and 42 months.Using a BSID III kit, expressive communication and receptive communication were analyzed for this study.

Statistical Analysis
The result analysis was done using the statistical software R version 4.0.2 with the assistance of a qualified medical statistician.For this, the data were recorded into an excel sheet, tabulated, and statistically analyzed.Continuous variables were represented by Mean ± SD/ Median, and categorical variables were represented by frequency and percentage.Comparison of GMA at 3 different times is done by Wilcoxon matched pairs test.Comparison of GMA and BSID III scaled scores is done by Mann-Whitney U test.The level of significance was considered 5% (P < .05).

Results
Eighteen infants were recruited, 2 infants' parents did not follow-up at the high-risk baby clinic after discharge from NICU, while 1 infant's family shifted out of the study area.So, 16 infants' data were statistically analyzed.Neonatal and mother demographic characteristics are explained in Table 1.
A comparison of neonatal variables and socioeconomic status with the repeated measure of GMA at 3 different times was done using the chi-square test.The association was not statistically significant for any of the characteristics.However, some increment in values was obtained.In ≤32 weeks' gestational age (GA), the percentage increase is from 50% to 58.33% to eventually 66.67% at the fifth month.In 32 to 36 weeks' GA, the percentage of subjects with normal FMs decreased from 50.00% to 33.33% till the fifth month as there were 3 infants dropped out by the fifth month.In the birth weight group, the <1.5 kg category showed improvement to normal FMs increased from 33.33% to 46.67%.Similarly, in the >2.5 kg group, percentage of normal FMs increased from 8.33% to 20%.This was not the case with the 1.5 to 2.5 kg category as there were 3 dropouts whose percentage deteriorated from 58.33% to 33.33%.The percentage of normal FMs improved from 58.33% to 73.33% in the >15 days' category.Less than 15 days' category, however, has shown decreased percentage due to 3 dropouts (41.67%-26.67%).Due to the smaller sample size, association of GMA with other primary complications of the infant could not be analyzed (P < .05,Table 2).
The total number of normal GMs at recruitment improved from 12 infants (66.67%) to 15 infants (83.33%).The 6 infants had GMA (Writhing movements-poor repertoire) at recruitment and improved to normal FMs at 3 months; hence, no abnormal movement subjected at the fifth month.There was 1 dropout after the first assessment and 2 dropped out before the final assessment.Nonetheless, GMA from the third month to the fifth month shows significant improvement as Z = 2.0226 and P = .0431.Overall from recruitment to fifth month, P value shows statistically significance Z = 2.2014 and P = .0277(P < .05,Table 3).
General movement assessment at recruitment and third month with scaled scores of BSID III Language subtest (receptive communication P = .1753and .0758and Expressive communication P = .4437and .4260)scores did not show a statistically significant difference (P < .05,Table 4).The composite scores of BSID III did not depict a statistically significant association with GMs at recruitment and third month (Table 5).

Discussion
The objective of the study was to evaluate the effectiveness of ROR intervention on language development for infants in NICU using GMA and BSID III.Neonatal characteristics like gestation age of fewer than 32 weeks more than 2500 g birth weight and more than 15 days of NICU stay had a positive impact on the infant's general movements over time.Six infants who had GMA (Writhing movements-poor repertoire) at recruitment improved to normal FMs at 3 months.The intervention had a significant impact on the general movements of the infants; on the contrary, it did not have a statistical influence over the language development of the infant as assessed by the BSID III language subtest.In this study, there was more number of infants that were born very preterm showing poor repertoire in their GMs when compared with infants born moderate to late preterm.This is supported by the previous evidence conducted to determine the GMs and Motor Optimality Score of 40 early preterm infants concluded that in preterm at writhing age, the poor repertoire is common.At fidgety age, however, the majority of normal FMs are seen. 12The reason could be, physiologically, the complete development of the structures of the inner ear occurs between 24 and 26 weeks of GA, and gaining auditory stimuli begins during this period.As a result, when the infant is taken out of that environment and placed in the NICU, neural differentiation is altered, which may affect forthcoming development.The sensory environment influences brain growth, structures, connectivity, and function throughout the first 3 years of life, making this a critical period of brain plasticity. 13lso, the present study validates the utilization of GMA as an outcome to evaluate early motor repertoire as a valid instrument for determining the infant's neurological functioning.
As studies suggest, the commonest cause of NICU stay in India is the low birth weight (<2500g). 14It, therefore, also increases the number of days in NICU causing increased exposure to the NICU environment.Neonatal intensive care unit architecture promotes social seclusion, language deprivation, and the likelihood of atypical language development.Ambient noise blocks most human discussions in a multi-bed NICU, robbing the infant of relevant linguistic input.Human speech exposure during the neonatal period, particularly the voice of the mother, imparts linguistic richness that can be critical for the brain's early wiring for language development. 3The demographics of our study have shown similar results.There was more number of participants in the low birth weight category (<2500 g) that showed poor repertoire than the subjects with birth weight more than 2500 g.
Current studies on the influence of socioeconomic status on language outcomes continue to comprehend the significance of educational qualifications. 5In our current study, poor repertoire seen at an early stage was more in subjects with lower middle socioeconomic status.Evidence suggests that low socioeconomic status infants encounter considerable discrepancy in linguistic exposure during the beginning of childhood and perhaps, therefore, have lower levels of vocabulary growth, school keenness, and reading skills. 6The variation in the words used or auditory stimuli given is more in higher socioeconomic status, hence predicting its ill effects at later preschool age.
As infant's nervous system is immature at the beginning and as the infant nears the term age, the plasticity of the brain is enhanced which demands the need to incorporate an enriched intervention to positively influence the development of the child.Early intervention is essential in modifying the underlying neural mechanism in the context of myelination, creation, and sprouting of neural projections for the development of the child. 13revious research revealed extremely low birth weight infants vocalize as early as 8 weeks before their expected date of delivery; parent talk is a significant predictor of both infant vocalizations and conversation turns at 32 and 36 weeks' gestation.Furthermore, every 100 adult word count/hour (AWC/h) increase in the NICU at 32-week gestation was linked to a 2-point rise in Bayley III, language composite score at 18 months (P = 5.04).At 36-week gestation, every 100 AWC/h improvement was linked with a 1.2-point rise in the BSID, cognitive composite score (P = 5.004) and a 0.3point increase in expressive communication at 18 months.This strongly suggests that parents converse in the NICU during the weeks leading up to an infant's expected date have a significant effect on their later cognitive and linguistic abilities. 15On this background, in our study, BSID III was assessed between 5 months 0 day and 6 months 30 days time period and was correlated with GMA at recruitment and corrected aged 3 months.However, statistically significant changes were not obtained.
In the present study as GMs have improved at the third assessment, these findings back up the idea of executing caregiving programs with the involvement of the family in the neonatal intensive care units (ICUs), implying that early born babies avail the benefit from increased parental involvement and contact, such as caretaking, kangaroo care, snuggling, conversing, singing a song, and reading.Reach Out and Read was instrumental in incorporating parts of early intervention in this study by adhering to that.It was valuable in obtaining the active engagement of the mother and family in the intervention.
Early reading activities that strengthen parent-child relationships can play an important role in developing emergent literacy abilities and preparing children for school. 6With caring bonds between parents and newborns, early literacy starts in a child's initial days.Reach Out and Read is a program that focuses on giving resources, information, and assistance to low-income families so that they can concentrate on books and reciting loudly as one of the most crucial parenting skills in parent-child interaction.The assessment of the intended infant and the parent for reading experience is the first step in promoting literacy development. 4he relationship between inadequate repertoire and FMs and the BSID III scaled score for its receptive and expressive communication language components was not found to be statistically significant in our study.Consequently, the findings of the study reaffirm that the Bayley III has low predictive validity under 12 months of age 16 and signifies the importance of developing a valid developmental assessment tool for infants under 12 months of age.Therefore, our findings are not generalizable to this subpopulation.
This study, however, has a few limitations.The infants dropped off the study as they had minimal complications during birth and hence fewer days of admission in the NICU.Parents of these infants did not revisit the hospital for follow-up as they felt reading out loud to their children did not make any difference as the infants would not understand anything.Nonetheless, to the best of our knowledge, this is a first-of-its-kind study in the selected part of the country to implement an early intervention to improve language development in infants admitted to NICU.Secondly, when there is a paucity of evidence concerning early intervention for linguistic skills, ROR intervention provided an early stimulating environment in the NICU.Third, ROR encouraged the active participation of the mother, which improved mother-child bonding.

Conclusion
Reach Out and Read training program that actively involves parents by providing a literacy-rich waiting room, anticipatory guidance, and a book to take home confirms its effectiveness in promoting general movement developmental trajectories of infants admitted to NICU.Although the proposed study is a preliminary study involving a smaller sample size in the NICU setting, ROR has been found to be a promising and practicable new language intervention with positive short-term outcomes on GMA.A high-powered randomized controlled trial with long-term targets is urgently needed to evaluate and generalize whether ROR can help these infants progress in their language development trajectories.

Table 1 .
Demographic Characteristics of Infants and Parents.

Table 2 .
Comparison of Neonatal Variables and Socio-economic Status With Repeated Measure of General Movement Assessment at 3 Different Times.

Table 3 .
Comparison of General Movement Assessment at Recruitment, at Third Month and at Fifth Month Time Points By Wilcoxon Matched Pairs Test.

Table 4 .
Comparison of General Movement Assessment at Recruitment and Third Month With Scaled Scores of Bayley Scale of Infant Development III By Mann-Whitney U test.
Abbreviations: GMA, general movement assessment; BSID III, Bayley Scale of Infant Development III; SD, standard deviation.

Table 5 .
Comparison of General Movement Assessment at Recruitment and Third Month With Bayley Scale of Infant Development III Composite Scores By Mann-Whitney U test.