Stories to Take the Edge Off Pain During Immunization for Preschoolers: A Randomized Controlled Trial.

IMPORTANCE: Fear and distress during immunization may lead to long-term preprocedural anxiety and nonadherence to immunization schedules. Pictorial stories provide a way of educating the parent and child about the procedure. OBJECTIVE: To determine the efficacy of pictorial stories in reducing pain perception among children and anxiety among mothers during immunization. DESIGN: Three-arm randomized controlled trial Setting: Immunization clinic of a tertiary care hospital in South India. PARTICIPANTS: Fifty children ages 5 to 6 yr, who reported to the hospital for measles, mumps, and rubella and typhoid conjugate virus vaccines. Inclusion criteria were that the child was accompanied by the mother and maternal knowledge of either Tamil or English. Exclusion criteria were child hospitalization in the past year or neonatal intensive care unit admission in the neonatal period. INTERVENTION: Pictorial story regarding immunization before the procedure that contained information related to immunization, coping strategies, and distraction techniques. OUTCOMES AND MEASURES: Pain perception was evaluated using the Sound, Eye, Motor Scale; the Observation Scale of Behavioral Distress; and the Wong-Baker FACES Pain Rating Scale (FACES). Maternal anxiety was measured using the General Anxiety-Visual Analog Scale. RESULTS: Of 50 children recruited, 17 were in the control group, 15 were in the placebo group, and 18 were in the intervention group. Children in the intervention group reported lower pain scores on the FACES (p = .04) compared with the placebo and control groups. CONCLUSIONS AND RELEVANCE: A pictorial story is a simple and cost-effective intervention to reduce pain perception among children. What This Article Adds: Pictorial stories may be a feasible, simple, and cost-effective intervention to reduce pain perception during immunization.

South Indian Children's Neurodevelopmental Outcomes After Group B Streptococcus Invasive Disease: A Matched-Cohort Study.

BACKGROUND: This study is part of a multicountry matched-cohort study designed to estimate the risk of long-term neurodevelopmental impairment (NDI) of children exposed to invasive group B Streptococcus (iGBS). The specific objective of this paper is to compare NDI across domains of iGBS survivors with a matched non iGBS group in our population. METHODS: Survivors of iGBS in a South Indian hospital were identified and recruited between January 2020 and April 2021. Cases were compared with age- and gender-matched non iGBS children. Participants were assessed using Bayley Scales of Infant and Toddler Development-3rd edition (BSID-III), Wechsler Preschool and Primary Scale of Intelligence-4th edition (WPPSI-IV), Wechsler Intelligence Scale for Children-5th edition (WISC-V), Child Behavior Checklist (CBCL), and Bruininks-Oseretsky Test of Motor Proficiency, 2nd edition (BOT-2), depending on age. RESULTS: Our cohort comprised 35 GBS-exposed and 65 matched non iGBS children, aged 1-14 years. The iGBS-exposed group had 17 (48.6%) children with impairment in ≥1 domain compared to 25 (38%) in the non iGBS group (unadjusted OR, 1.51; 95% CI, .65-3.46), 9 (26%) children with "multi-domain impairment" compared to 10 (15.4%) in the non iGBS group (unadjusted OR, 1.90; 95% CI, .69-5.24), and 1 (2.9%) child with moderate to severe impairment compared to 3 (4.6%) in the non iGBS group (unadjusted OR, .60; 95% CI, .06-6.07). In the iGBS group, more children had motor impairments compared with the non iGBS group (unadjusted OR, 10.7; 95% CI, 1.19-95.69; P = .034). CONCLUSIONS: Children with iGBS seem at higher risk of developing motor impairments compared with a non iGBS group.

Emotional and Behavioral Outcomes in Childhood for Survivors of Invasive Group B Streptococcus Disease in Infancy: Findings From 5 Low- and Middle-Income Countries.

BACKGROUND: Survivors of invasive group B Streptococcus (iGBS) disease, notably meningitis, are at increased risk of neurodevelopmental impairment. However, the limited studies to date have a median follow-up to 18 months and have mainly focused on moderate or severe neurodevelopmental impairment, with no previous studies on emotional-behavioral problems among iGBS survivors. METHODS: In this multicountry, matched cohort study, we included children aged 18 months to 17 years with infant iGBS sepsis and meningitis from health demographic surveillance systems, or hospital records in Argentina, India, Kenya, Mozambique, and South Africa. Children without an iGBS history were matched to iGBS survivors for sex and age. Our primary outcomes were emotional-behavioral problems and psychopathological conditions as measured with the Child Behavior Checklist (CBCL). The CBCL was completed by the child's primary caregiver. RESULTS: Between October 2019 and April 2021, 573 children (mean age, 7.18 years) were assessed, including 156 iGBS survivors and 417 non-iGBS comparison children. On average, we observed more total problems and more anxiety, attention, and conduct problems for school-aged iGBS survivors compared with the non-iGBS group. No differences were found in the proportion of clinically significant psychopathological conditions defined by the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). CONCLUSIONS: Our findings suggested that school-aged iGBS survivors experienced increased mild emotional behavioral problems that may affect children and families. At-risk neonates including iGBS survivors need long-term follow-up with integrated emotional-behavioral assessments and appropriate care. Scale-up will require simplified assessments that are free and culturally adapted.

Nonnutritive Sucking at the Mother's Breast Facilitates Oral Feeding Skills in Premature Infants: A Pilot Study.

BACKGROUND: Premature infants have difficulties in transitioning from gavage to breastfeeding. Targeted interventions to support breastfeeding in premature infants in the neonatal intensive care unit are scarce. PURPOSE: This pilot study evaluates the effectiveness of nonnutritive sucking at the mother's breast in premature infants to facilitate breastfeeding performance and exclusive breastfeeding. METHODS: The study design constituted a single-blinded randomized control trial, with 9 participants randomly allocated into experimental (n = 4) and control (n = 5) groups. The intervention, nonnutritive sucking at the mother's breast thrice a day for 5 minutes, till nutritive breastfeeding was started, was done in addition to standard care, which was nonnutritive sucking on a finger during gavage feeds. The control group received only standard care. Nonnutritive sucking was assessed using "Stages of Nonnutritive Sucking Scale," and breastfeeding performance was assessed using the "Preterm Infant Breastfeeding Behavior Scale" by a blinded assessor unaware of the infants' allocation. RESULTS: Five infants in the control arm and 4 in the intervention arm completed the study. The infants in the intervention group showed faster transition to mature stages of nonnutritive sucking (P = .05) and had longer sucking bursts during breastfeeding (P = .06) than those in the control group. There was no difference in the rates of exclusive breastfeeding at 6 months in the intervention and control groups. IMPLICATIONS FOR PRACTICE: Early initiation of nonnutritive sucking at the mother's breast in very preterm infants is a safe and effective intervention to facilitate maturation of oral feeding and breastfeeding behavior. IMPLICATIONS FOR RESEARCH: Nonnutritive sucking at the mother's breast can be explored as an intervention, with a larger sample, to facilitate exclusive breastfeeding and to establish intervention fidelity.

Mustard Seed Pillow for Prevention of Deformational Plagiocephaly in ≤ 32 Weeks' Gestational Age Infants: An Open Label Randomized.

OBJECTIVES: To assess the effectiveness of using mustard seed filled pillows in preventing deformational plagiocephaly (DP) in premature infants. METHODS: A prospective open label randomized trial was conducted in a tertiary care hospital in South India. Eligible preterm infants born at ≤32 weeks and <1500 g admitted in the neonatal intensive care unit (NICU) were randomly allocated to the intervention and control groups. In addition to standard nesting, the intervention group was positioned using a mustard pillow, while the control group was positioned using nesting alone. Plagiocephaly was assessed using the Cranial Index (CI), Cranial Vault Asymmetry Index (CVAI) and Argenta classification within the first week and at 4 weeks postnatal age. RESULTS: Twenty-eight infants, each in the control and intervention groups, were included for analysis. At 4 weeks postnatal age, the intervention group had lower mean (SD) CVAI scores when compared to the control group [3.16 (1.89 vs 7.85 (2.63)] with adjusted odds ratio, aOR (95% CI) of 28.2 (3.8, 210.01), P < 0.01. More number of infants in the control group had plagiocephaly measured using Argenta classification [aOR (95% CI) 25.70 (2.80, 235.67), P < 0.01]. There were no differences in the Cranial Index scores in the intervention and control groups [aOR (95% CI) 0.41 (0.11, 1.52), P = 0.184]. CONCLUSION: A mustard seed pillow is an easily available and a cost-effective intervention for preventing plagiocephaly in hospitalized preterm infants.

Long-term healthcare utilisation, costs and quality of life after invasive group B Streptococcus disease: a cohort study in five low-income and middle-income countries.

INTRODUCTION: There are no published data on the long-term impact of invasive group B Streptococcus disease (iGBS) on economic costs or health-related quality of life (HRQoL) in low-income and middle-income countries. We assessed the impact of iGBS on healthcare utilisation, costs and HRQoL in Argentina, India, Kenya, Mozambique and South Africa. METHODS: Inpatient and outpatient visits, out-of-pocket (OOP) healthcare payments in the 12 months before study enrolment, and health-state utility of children and caregivers (using the EuroQol 5-Dimensions-3-Level) were collected from iGBS survivors and an unexposed cohort matched on site, age at recruitment and sex. We used logistic or Poisson regression for analysing healthcare utilisation and zero-inflated gamma regression models for family and health system costs. For HRQoL, we used a zero-inflated beta model of disutility pooled data. RESULTS: 161 iGBS-exposed and 439 unexposed children and young adults (age 1-20) were included in the analysis. Compared with unexposed participants, iGBS was associated with increased odds of any healthcare utilisation in India (adjusted OR 11.2, 95% CI 2.9 to 43.1) and Mozambique (6.8, 95% CI 2.2 to 21.1) and more frequent healthcare visits (adjusted incidence rate ratio (IRR) for India 1.7 (95% CI 1.4 to 2.2) and for Mozambique 6.0 (95% CI 3.2 to 11.2)). iGBS was also associated with more frequent days in inpatient care in India (adjusted IRR 4.0 (95% CI 2.3 to 6.8) and Kenya 6.4 (95% CI 2.9 to 14.3)). OOP payments were higher in the iGBS cohort in India (adjusted mean: Int$682.22 (95% CI Int$364.28 to Int$1000.16) vs Int$133.95 (95% CI Int$72.83 to Int$195.06)) and Argentina (Int$244.86 (95% CI Int$47.38 to Int$442.33) vs Int$52.38 (95% CI Int$-1.39 to Int$106.1)). For all remaining sites, differences were in the same direction but not statistically significant for almost all outcomes. Health-state disutility was higher in iGBS survivors (0.08, 0.04-0.13 vs 0.06, 0.02-0.10). CONCLUSION: The iGBS health and economic burden may persist for years after acute disease. Larger studies are needed for more robust estimates to inform the cost-effectiveness of iGBS prevention.

Torn between two worlds: parental experiences of neonatal follow-up for infants with hypoxic ischaemic encephalopathy in India-a qualitative study using interpretative phenomenological analysis.

OBJECTIVE: This study aimed to understand the barriers and facilitators of a neonatal follow-up programme, as perceived by parents of infants born with hypoxic ischaemic encephalopathy (HIE). DESIGN: This study applied a qualitative study design using interpretative phenomenological analysis. It included focus group discussions, face-to-face in-depth interviews and telephonic interviews. Data were analysed using thematic content analysis. SETTING: Neonatal follow-up clinic of a tertiary hospital in South India. The study was conducted between March and December 2020. PARTICIPANTS: Five fathers and eight mothers of infants with HIE. RESULTS: Parents of children with HIE are torn between two worlds-an atmosphere of support and one of criticism. Three main themes were identified: (1) neonatal intensive care unit (NICU) stay: distressful versus reassuring experiences; (2) parenthood: supportive versus unsupportive environments; and (3) neonatal follow-up: adherence versus non-adherence. CONCLUSION: Parents of children with HIE experience sociocultural barriers in the NICU, after discharge and during the follow-up period. These lead to a complex array of emotional and physical consequences that affect parenting and follow-up care.

Preterm General Movements in Prediction of Neurodevelopmental Disability and Cerebral Palsy at Two Years: A Prospective Cohort Study.

Background: A neurological assessment before discharge from the NICU would enable early targeted intervention to mitigate the risk and severity of cerebral palsy (CP) and neurodevelop-mental disability. OBJECTIVE: To assess the accuracy of general movements (GM) in the preterm and fidgety movement periods in predicting neurodevelopmental disability and cerebral palsy in very preterm infants (≤32 weeks gestational age) at 18-24 months corrected gestational age. STUDY DESIGN: Prospective cohort study. PARTICIPANTS: One hundred and seventy very preterm infants, mean (SD) gestation 29.8 (1.32) weeks, and birthweight 1215 (226) g. OUTCOMES: Infants underwent GM assessments in the preterm period (31-36 weeks post-conception age) and fidgety movement period (8-18 weeks post term age). Neurodevelop-mental outcomes were assessed in 127 children using the Griffiths Mental Developmental Scales-2. RESULTS: Nine children had neurodevelopmental disability (two infants with cerebral palsy and seven with global developmental delay. The relative risk (95% CI) for neurodevelopmental disability was 1.46 (0.31-6.89) with preterm movements and 6.07 (0.97 - 38.05) with fidgety movements. Sensitivity and specificity values for the prediction of neurodevelopmental disability were 33% and 64% in the preterm period and 25% and 92% in the fidgety movement period, respectively. The sensitivity and specificity values for prediction of CP were 50% and 63% in the preterm period and 100% and 93% in the fidgety movement period, respectively. CONCLUSION: Preterm movements showed lower sensitivity and specificity than fidgety movements in predicting later CP and neurodevelopmental disability in preterm infants.

Neurodevelopmental and growth outcomes after invasive Group B Streptococcus in early infancy: A multi-country matched cohort study in South Africa, Mozambique, India, Kenya, and Argentina.

Background: Data are limited regarding long-term consequences of invasive GBS (iGBS) disease in early infancy, especially from low- and middle-income countries (LMIC) where most cases occur. We aimed to estimate risk of neurodevelopmental impairment (NDI) in children with a history of iGBS disease. Methods: A multi-country matched cohort study was undertaken in South Africa, India, Mozambique, Kenya, and Argentina from October 2019 to April 2021. The exposure of interest was defined as a history of iGBS disease (sepsis or meningitis) before 90 days of age, amongst children now aged 1·5-18 years. Age and sex-matched, children without history of GBS were also recruited. Age-appropriate, culturally-adapted assessments were used to define NDI across multiple domains (cognitive, motor, hearing, vision, emotional-behaviour, growth). Pooled NDI risk was meta-analysed across sites. Association of iGBS exposure and NDI outcome was estimated using modified Poisson regression with robust variance estimator. Findings: Amongst 138 iGBS survivors and 390 non-iGBS children, 38·1% (95% confidence interval [CI]: 30·0% - 46·6%) of iGBS children had any NDI, compared to 21·7% (95% CI: 17·7% - 26·0%) of non- iGBS children, with notable between-site heterogeneity. Risk of moderate/severe NDI was 15·0% (95% CI: 3·4% - 30·8%) among GBS-meningitis, 5·6% (95% CI: 1·5% - 13·7%) for GBS-sepsis survivors. The adjusted risk ratio (aRR) for moderate/severe NDI among iGBS survivors was 1.27 (95% CI: 0.65, 2.45), when compared to non-GBS children. Mild impairment was more frequent in iGBS (27.6% (95% CI: 20.3 - 35.5%)) compared to non-GBS children (12.9% (95% CI: 9.7% - 16.4%)). The risk of emotional-behavioural problems was similar irrespective of iGBS exposure (aRR=0.98 (95% CI: 0.55, 1.77)). Interpretation: Our findings suggest that iGBS disease is on average associated with a higher risk of moderate/severe NDI, however substantial variation in risk was observed between sites and data are consistent with a wide range of values. Our study underlines the importance of long-term follow-up for at-risk neonates and more feasible, standardised assessments to facilitate diagnosis in research and clinical practice. Funding: This work was supported by a grant (INV-009018) from the Bill & Melinda Gates Foundation to the London School of Hygiene &Tropical Medicine.

Group B streptococcus infection during pregnancy and infancy: estimates of regional and global burden.

BACKGROUND: Group B streptococcus (GBS) colonisation during pregnancy can lead to invasive GBS disease (iGBS) in infants, including meningitis or sepsis, with a high mortality risk. Other outcomes include stillbirths, maternal infections, and prematurity. There are data gaps, notably regarding neurodevelopmental impairment (NDI), especially after iGBS sepsis, which have limited previous global estimates. In this study, we aimed to address this gap using newly available multicountry datasets. METHODS: We collated and meta-analysed summary data, primarily identified in a series of systematic reviews published in 2017 but also from recent studies on NDI and stillbirths, using Bayesian hierarchical models, and estimated the burden for 183 countries in 2020 regarding: maternal GBS colonisation, iGBS cases and deaths in infants younger than 3 months, children surviving iGBS affected by NDI, and maternal iGBS cases. We analysed the proportion of stillbirths with GBS and applied this to the UN-estimated stillbirth risk per country. Excess preterm births associated with maternal GBS colonisation were calculated using meta-analysis and national preterm birth rates. FINDINGS: Data from the seven systematic reviews, published in 2017, that informed the previous burden estimation (a total of 515 data points) were combined with new data (17 data points) from large multicountry studies on neurodevelopmental impairment (two studies) and stillbirths (one study). A posterior median of 19·7 million (95% posterior interval 17·9-21·9) pregnant women were estimated to have rectovaginal colonisation with GBS in 2020. 231 800 (114 100-455 000) early-onset and 162 200 (70 200-394 400) late-onset infant iGBS cases were estimated to have occurred. In an analysis assuming a higher case fatality rate in the absence of a skilled birth attendant, 91 900 (44 800-187 800) iGBS infant deaths were estimated; in an analysis without this assumption, 58 300 (26 500-125 800) infant deaths from iGBS were estimated. 37 100 children who recovered from iGBS (14 600-96 200) were predicted to develop moderate or severe NDI. 40 500 (21 500-66 200) maternal iGBS cases and 46 200 (20 300-111 300) GBS stillbirths were predicted in 2020. GBS colonisation was also estimated to be potentially associated with considerable numbers of preterm births. INTERPRETATION: Our analysis provides a comprehensive assessment of the pregnancy-related GBS burden. The Bayesian approach enabled coherent propagation of uncertainty, which is considerable, notably regarding GBS-associated preterm births. Our findings on both the acute and long-term consequences of iGBS have public health implications for understanding the value of investment in maternal GBS immunisation and other preventive strategies. FUNDING: Bill & Melinda Gates Foundation.

Quantifying long-term health and economic outcomes for survivors of group B Streptococcus invasive disease in infancy: protocol of a multi-country study in Argentina, India, Kenya, Mozambique and South Africa.

Sepsis and meningitis due to invasive group B Streptococcus (iGBS) disease during early infancy is a leading cause of child mortality. Recent systematic estimates of the worldwide burden of GBS suggested that there are 319,000 cases of infant iGBS disease each year, and an estimated 147,000 stillbirths and young-infant deaths, with the highest burden occurring in Sub-Saharan Africa.  The following priority data gaps were highlighted: (1) long-term outcome data after infant iGBS, including mild disability, to calculate quality-adjusted life years (QALYs) or disability-adjusted life years (DALYs) and (2) economic burden for iGBS survivors and their families. Geographic data gaps were also noted with few studies from low- and middle- income countries (LMIC), where the GBS burden is estimated to be the highest. In this paper we present the protocol for a multi-country matched cohort study designed to estimate the risk of long-term neurodevelopmental impairment (NDI), socioemotional behaviors, and economic outcomes for children who survive invasive GBS disease in Argentina, India, Kenya, Mozambique, and South Africa. Children will be identified from health demographic surveillance systems, hospital records, and among participants of previous epidemiological studies. The children will be aged between 18 months to 17 years. A tablet-based custom-designed application will be used to capture data from direct assessment of the child and interviews with the main caregiver. In addition, a parallel sub-study will prospectively measure the acute costs of hospitalization due to neonatal sepsis or meningitis, irrespective of underlying etiology. In summary, these data are necessary to characterize the consequences of iGBS disease and enable the advancement of effective strategies for survivors to reach their developmental and economic potential. In particular, our study will inform the development of a full public health value proposition on maternal GBS immunization that is being coordinated by the World Health Organization.

Activity based group therapy reduces maternal anxiety in the Neonatal Intensive Care Unit - a prospective cohort study.

BACKGROUND: A large proportion of mothers in the Neonatal Intensive Care Unit (NICU) experience psychological distress, which is associated with adverse infant and parenting outcomes. Interventions addressing maternal anxiety in the NICU are scarce. AIMS: To assess the effect of activity based group therapy on maternal anxiety in the NICU when compared to a control group. STUDY DESIGN: The study was a prospective phase lag cohort study. In Phase 1 the control group was recruited and assessed using the State-Trait Anxiety Inventory (STAI-S) once at recruitment and again 4 weeks later. In phase 2, mothers were invited to take part in activity-based groups of 1 h duration once a week for 4 weeks. The STAI-S was administered before and after every group session. SUBJECTS: Mothers of babies admitted in the NICU who consented to participate, had a working knowledge of Tamil or English and were likely to stay for 4 weeks for the treatment were included. OUTCOME MEASURES: State anxiety assessed using the STAI-S. RESULTS: Seventeen mothers each in the control and experimental groups completed the study. In the experimental group, there was a significant reduction in the post-test anxiety scores when compared to the pre-test in the first (p = 0.005), third (p = 0.07) and fourth (p = 0.009) sessions. The post-test anxiety scores of the intervention group was significantly lower than that of the control group (p = 0.009). CONCLUSION: Activity based group therapy is effective as an intervention in reducing maternal anxiety in the NICU. SUMMARY: Anxiety in mothers of infants admitted in the NICU has been associated with adverse infant and parenting outcomes. This study evaluated the feasibility and effectiveness of an activity based group intervention to reduce anxiety levels in mothers in the NICU. The study was a prospective phase lag cohort study. Anxiety levels were assessed in mothers in the control group at recruitment and then 4 weeks later. In the intervention group, activity based group sessions were conducted once a week for 4 weeks. State anxiety was assessed before and after every group session. In the intervention group the anxiety levels were significantly lower in the post-test, when compared to the pre-test. Also the number of mothers suffering from moderate to severe anxiety and the anxiety scores in the post-test were significantly lower in the intervention group when compared to the control group. We conclude that activity based group sessions are effective in reducing the state anxiety in mothers in the NICU. Improving maternal psychological wellbeing may indirectly contribute to better infant outcomes.

Early motor repertoire in very low birth weight infants in India is associated with motor development at one year.

BACKGROUND: Most studies on Prechtl's method of assessing General Movements (GMA) in young infants originate in Europe. AIM: To determine if motor behavior at an age of 3 months post term is associated with motor development at 12 months post age in VLBW infants in India. METHODS: 243 VLBW infants (135 boys, 108 girls; median gestational age 31wks, range 26-39wks) were video-recorded at a median age of 11wks post term (range 9-16wks). Certified and experienced observers assessed the videos by the "Assessment of Motor Repertoire - 2-5 Months". Fidgety movements (FMs) were classified as abnormal if absent, sporadic or exaggerated, and as normal if intermittently or continually present. The motor behaviour was evaluated by repertoire of co-existent other movements (age-adequacy) and concurrent motor repertoire. In addition, videos of 215 infants were analyzed by computer and the variability of the spatial center of motion (CSD) was calculated. The Peabody Developmental Motor Scales was used to assess motor development at 12 months. RESULTS: Abnormal FMs, reduced age adequacy, and an abnormal concurrent motor repertoire were significantly associated with lower Gross Motor and Total Motor Quotient (GMQ, TMQ) scores (p < 0.05). The CSD was higher in children with TMQ scores <90 (-1SD) than in children with higher TMQ scores (p = 0.002). CONCLUSION: Normal FMs (assessed by Gestalt perception) and a low variability of the spatial center of motion (assessed by computer-based video analysis) predicted higher Peabody scores in 12-month-old infants born in India with a very low birth weight.