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1.
Front Pediatr ; 11: 1296863, 2023.
Article in English | MEDLINE | ID: mdl-38034824

ABSTRACT

Background: Oral motor stimulation interventions improve oral feeding readiness and earlier full oral feeding in preterm neonates. However, using a structured method may improve the transition time to full oral feeds and feeding efficiency with respect to weight gain and exclusive breastfeeding when compared to an unstructured intervention. Objective: To compare the effect of Premature Infant Oral Motor Intervention (PIOMI) and routine oromotor stimulation (OMS) on oral feeding readiness. Methods: Randomised controlled trial conducted in a neonatal intensive care unit between June-December 2022. Preterm neonates, 29+0-33+6 weeks corrected gestational age, were studied. The intervention group received PIOMI and the control group received OMS. Primary outcome: time to oral feeding readiness by Premature Oral Feeding Readiness Assessment Scale (POFRAS) score ≥30. Secondary outcomes: time to full oral feeds, duration of hospitalisation, weight gain, and exclusive breastfeeding rates. Results: A total of 84 neonates were included and were randomised 42 each in PIOMI and OMS groups. The mean chronological age and time to oral feeding readiness were lower by 4.6 and 2.7 days, respectively, for PIOMI. The transition time to full oral feeds was 2 days lower for PIOMI and the duration of hospitalisation was 8 days lower. The average weight gain was 4.9 g/kg/day more and the exclusive breastfeeding rates at 1 month and 3 months post-discharge were higher by 24.5% and 27%, respectively, for the PIOMI group. The subgroup analysis of study outcomes based on sex and weight for gestational age showed significant weight gain on oral feeds in neonates receiving PIOMI. Similarly, the subgroup analysis based on gestational age favoured the PIOMI group with significantly earlier transition time and weight gain on oral feeds for the neonates >28 weeks of gestational age. The odds of achieving oral feeding readiness by 30 days [OR 1.558 (0.548-4.426)], full oral feeds by 45 days [OR 1.275 (0.449-3.620)], and exclusive breastfeeding at 1 month [OR 6.364 (1.262-32.079)] and 3 months [3.889 (1.186-12.749)] after discharge were higher with PIOMI. Conclusion: PIOMI is a more effective oromotor stimulation method for earlier and improved oral feeding in preterm neonates. Clinical trial registration: https://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=70054&EncHid=34792.72281&modid=1&compid=19','70054det', identifier, CTRI/2022/06/043048.

2.
Indian Pediatr ; 60(12): 1001-1004, 2023 Dec 15.
Article in English | MEDLINE | ID: mdl-37822205

ABSTRACT

OBJECTIVE: This study aims to establish linguistic equivalence of the Marathi translation of the Ages and Stages Questionnaires-Third Edition (ASQ-3) in an urban setting of India. METHODS: All items of the ASQ-3 were translated and back translated by translators from a non-medical background, piloted on 40 families and reviewed by an expert panel. The final version, adjusted for linguistic equivalence, was tested on 111 bilingual parents recruited to complete questionnaires about their children in both English and Marathi. Intraclass correlation coefficient (ICC), a measure of reliability, were calculated between responses in both languages for each domain of the ASQ-3. RESULTS: ICC for each of the five domains were communication: 0.77; gross motor: 0.88; fine motor: 0.80; problem solving: 0.84; personal-social: 0.84. There were no statistically significant differences between Marathi and English questionnaires. CONCLUSION: This Marathi translation of the ASQ-3 was linguistically equivalent to the English version, and can be utilized for developmental screening with Marathi-speaking families.


Subject(s)
Child Development , Linguistics , Child , Humans , Infant , Reproducibility of Results , Surveys and Questionnaires , Psychometrics , India
3.
J Ultrasound ; 26(4): 851-859, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37728683

ABSTRACT

OBJECTIVES: To measure the Doppler velocimetry parameters in the anterior cerebral artery (ACA), superior mesenteric artery (SMA), and main renal artery (RA) in neonates with late-onset sepsis and correlate it with associated clinical morbidities. METHODOLOGY: Prospective observational study carried out at a tertiary-level neonatal intensive care unit in India in 2022, enrolling 20 neonates with late-onset neonatal sepsis (LONS). Baseline characteristics and sepsis parameters obtained. Serial ultrasound performed on days 1, 3, and 7 from the day of clinical sepsis in the ACA, SMA, and RA and velocimetry measurements obtained. The findings were compared with 20 gestational age (GA) matched neonates in the control arm. RESULTS: The mean GA of neonates with LONS was 31.03 ± 2.79 weeks and their mean birthweight was 1474 ± 509.99 g. The peak systolic velocity, resistive and pulsatility indices were significantly higher in ACA, SMA, and RA and the end-diastolic velocity was significantly lower in ACA and RA (P < 0.05) in LONS. The incidences of intraventricular hemorrhage (IVH), necrotising enterocolitis (NEC), and acute kidney injury (AKI) in neonates with LONS were 45%, 50%, and 10% respectively. A subgroup analysis of the Doppler velocimetry parameters in the neonates with LONS and for neonates with and without clinical outcomes did not suggest a significant difference. CONCLUSION: LONS is associated with alterations in cerebral, splanchnic, and renal perfusion seen as abnormal blood flow velocimetry and vascular resistance which may predispose to IVH, NEC, and AKI.


Subject(s)
Acute Kidney Injury , Neonatal Sepsis , Sepsis , Infant, Newborn , Humans , Neonatal Sepsis/diagnostic imaging , Ultrasonography , Sepsis/diagnostic imaging , Gestational Age , Blood Flow Velocity , Ultrasonography, Doppler
4.
Front Pediatr ; 11: 1296184, 2023.
Article in English | MEDLINE | ID: mdl-38250589

ABSTRACT

Introduction: The current recommendations for the management of neonatal polycythemia are that partial exchange transfusion (PET) should be performed if the hematocrit is >70% in an asymptomatic neonate, or if the haematocrit is >65% in a symptomatic neonate. The hemodynamic effects of PET for neonatal polycythemia have not been well researched. Objectives: To evaluate the hemodynamic effects of PET in neonates with polycythemia. Methodology: Prospective observational study conducted in a neonatal intensive care unit of a tertiary care teaching hospital enrolling 21 neonates with polycythemia who underwent PET. Hemodynamic and echocardiographic parameters were obtained prior to PET and 6 h after procedure. Results: The mean gestational age of neonates with polycythemia was 35.08 ± 2.35 weeks with a mean birth weight of 1,929 ± 819.2 g. There was a significant improvement noted in heart rate and oxygen saturation post PET procedure (p < 0.05). Right ventricular systolic function parameters showed significant improvement (Tricuspid annular plane systolic excursion, fractional area change, right ventricular output) (p < 0.05). Left ventricular function parameters showed significant improvement (Fractional shortening, left ventricular output, E:A ratio) (p < 0.05). Resolution of symptoms was noted after PET procedure with no adverse events associated with PET. Conclusion: PET maybe effective in improving heart rate and oxygen saturation levels in polycythemic neonates. It has good short-term hemodynamic stability with improvement in right ventricular systolic, as well as left ventricular systolic and diastolic function. It is a safe and effective procedure with minimal adverse effects. Further studies with larger sample size and a control group would be required to corroborate our findings.

5.
Child Neuropsychol ; 28(3): 337-354, 2022 04.
Article in English | MEDLINE | ID: mdl-34592908

ABSTRACT

Studies from high-income countries report associations of preeclampsia (PE) with reduced cognitive function and adverse behavioural outcomes in children. We examined these associations in Indian children aged 5-7 years. Children of mothers with PE (n=74) and without PE (non-PE; n=234) were recruited at delivery at Bharati Hospital, Pune, India. The cognitive performance was assessed using 3 core tests from the Kaufman Assessment Battery and additional tests including Verbal fluency, Kohs block design, and Coding A (from Wechsler Intelligence Scale for Children). The parent-reported Strengths and Difficulties Questionnaire (SDQ) was used to assess children's behavioral characteristics. Scores were compared between children from PE and non-PE groups, and associations analyzed further using regression models, adjusted for potential confounders. After adjusting for age, sex, socio-economic status and maternal education, children of PE mothers had lower Kohs block design scores (adjusted odds ratio per score category 0.57, [95% CI 0.34-0.96] p=0.034; 0.62 [95%CI (0.36, 1.07), p=0.09 on further adjustment for birth weight and gestation) compared to children of mothers without PE. In the SDQ, there was a lower prevalence of abnormal 'conduct problem' scores in PE group than non-PE group (OR=0.33, 95% CI 0.13-0.83, p=0.018, in the fully adjusted model); there were no differences for other behavioral domains. This preliminary study in Indian children suggests that fetal exposure to maternal PE may have an adverse impact on visuo-spatial performance but does not adversely affect behavior. Further studies with larger sample sizes are essential to understand effects of maternal PE on cognitive/behavioral outcomes in children.


Subject(s)
Pre-Eclampsia , Problem Behavior , Child , Cognition , Female , Humans , India , Mothers/psychology , Pregnancy
6.
Infection ; 50(1): 131-137, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34232457

ABSTRACT

PURPOSE: COVID-19 pandemic remains a serious public health threat worldwide. In view of the limited data on the risk of perinatal transmission of SARS-CoV-2 and transfer of maternal anti-SARS-CoV-2 antibodies, the present study was undertaken. METHODS: A prospective study including 57 pregnant women with a positive SARS-CoV-2 RNA test (SARS-CoV-2-RNA+) and 59 neonates born to them was conducted at Pune, India. 39 viral RNA negative (SARS-CoV-2-RNA-negative) pregnant women and their 39 neonates were included as controls. Neonatal nasal swab/cord blood samples were subjected to SARS-CoV-2 RNA detection by RT-PCR for investigation of perinatal transmission. Transfer of maternal antibodies was studied using ELISA and PRNT. RESULTS: 10/57 SARS-CoV-2-RNA+ mothers were symptomatic. The duration between COVID-19 diagnosis and delivery was ≤ 7 days for 82.4%. Perinatal transmission as evidenced by viral RNA in the neonatal nasal swab/cord blood (CB) was 3.6%. IgG-anti-SARS-CoV-2 positivity was 21.6%. Of the 39 neonates born to SARS-CoV-2-RNA-negative mothers, 20 (51%) and none, respectively, were positive for IgG-anti-SARS-CoV-2 and viral RNA. Preterm deliveries were higher in SARS-CoV-2-RNA+ (18.6%) than SARS-CoV-2 RNA-negative (0/39) mothers (p < 0.005). Respiratory distress at birth (< 4 h) was higher among neonates of SARS-CoV-2-RNA+ (20/59, 33.9%) than SARS-CoV-2-RNA-negative mothers (3/39, 7.7%; p < 0.001). ~ 75% IgG-positives exhibited neutralization potential with mean PRNT titers of 42.4 ± 24 (SARS-CoV-2-RNA+) and 72.3 ± 46.7 (SARS-CoV-2 RNA-negative); higher in the latter (p < 0.05). CONCLUSION: The rate of perinatal transmission was low. Transfer of maternal antibodies was lower among SARS-CoV-2-RNA+ mothers than SARS-CoV-2-RNA-negative mothers with subclinical infection during pregnancy. Presence of neutralizing antibodies in majority of IgG-positives suggests protection from SARS-CoV-2 in early life.


Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Asymptomatic Infections , COVID-19 Testing , Female , Humans , Immunoglobulin G , India , Infant, Newborn , Infectious Disease Transmission, Vertical , Mothers , Pandemics , Pregnancy , Pregnancy Complications, Infectious/epidemiology , Prospective Studies , RNA, Viral , SARS-CoV-2
7.
Front Public Health ; 9: 723807, 2021.
Article in English | MEDLINE | ID: mdl-34765581

ABSTRACT

Acute respiratory infections (ARIs) continue to be the most important cause of morbidity and mortality among under-five children. Some demographic and environmental factors are associated with ARIs among under-five children. This study was conducted with the objective to estimate the prevalence of ARIs among under-five children in the rural areas and densely populated urban slum areas in Maharashtra, India and to assess the association of the selected sociodemographic and household environmental factors with ARI. This study was conducted in 16 selected clusters from the rural areas and densely populated urban slum areas of the two districts in Maharashtra, India. Structured and validated proforma was used for collecting the data on the sociodemographic and household environmental risk factors. A total of 3,671 under-five children were surveyed. The prevalence of ARIs for the preceding month was 50.4%. It was higher among the children living in the rural areas (54.2%) compared to the children living in the urban areas (46.7%) (p = 0.01). The prevalence of ARIs was reported to be 51.4 and 49.4% in boys and girls, respectively. In the multivariate analysis, the researchers found that living in rural areas (p = 0.01) and parental smoking (p = 0.04) were significantly associated with the ARIs. An intervention such as reducing parental smoking habits at the household level may reduce ARIs.


Subject(s)
Poverty Areas , Respiratory Tract Infections , Child , Cross-Sectional Studies , Female , Humans , India/epidemiology , Male , Prevalence , Respiratory Tract Infections/epidemiology
8.
BMJ Open Qual ; 10(Suppl 1)2021 07.
Article in English | MEDLINE | ID: mdl-34344744

ABSTRACT

Feed intolerance and necrotising enterocolitis (NEC) are challenges while treating sick neonates. These can be reduced by giving human milk, but adequate availability of mother's own milk or pasteurised donor human milk (PDHM) is a challenge in neonatal setups, like ours, without an attached human milk bank. Hence, this quality improvement initiative was taken to improve donor human milk collection in our urban tertiary-care teaching hospital, to at least 500 mL per week in 4 weeks. After analysing the problem, our quality improvement team identified a shortage of human milk donation that was due to low awareness among the stakeholders and lack of a system to collect and store human milk and transport it to a milk bank. The team first established a system of supplies needed for milk collection, storage and transportation. It then tested change idea of information, education and counselling to increase milk donation. The team carried out a few plan-do-study-act cycles (individual and group counsellings, and usage of videos and information leaflets) to test the change ideas and adapted a few and abandoned some. During this journey, the milk collection increased to above the target amount. Various challenges were addressed, and there was a need for constant motivation of the stakeholders, especially the mothers, and now there is sustained milk donation in the setup. This is incorporated in the standard operating procedure and as a quality indicator of the unit for sustaining the changes in the unit. Our initiative can be replicated in other setups for increasing collection of donor human milk. Greater PDHM availability for sick neonates will, in effect, reduce NEC and feeding intolerance rates, leading to reduced hospital stay, morbidity, mortality and economic burden.


Subject(s)
Milk Banks , Milk, Human , Female , Hospitals, Teaching , Humans , Infant, Newborn , Infant, Premature , Quality Improvement
9.
Front Immunol ; 12: 592731, 2021.
Article in English | MEDLINE | ID: mdl-33968011

ABSTRACT

Childhood vaccination plays critical role in protecting infants from several dreaded diseases. Of the global 15 million preterm (PT) infants with compromised immune system born annually, India contributes to >3.5 million. Generation of adequate vaccine-induced immune response needs to be ensured of their protection. Immune response of Indian PT (n = 113) and full-term (FT, n = 80) infants to pentavalent vaccine administered as per the national recommendation was studied. Antibody titers against component antigens of pentavalent vaccine, immune cells profiling (T and B cells, monocytes and dendritic cells) and plasma cytokines were determined pre- and post-vaccination. Additionally, cell-mediated recall immune responses to pentavalent antigens were evaluated after short time antigenic exposure to infant PBMCs. Irrespective of gestational age (GA), all the infants developed adequate antibody response against tetanus, diphtheria, and protective but lower antibody levels for Haemophilus influenzae type-b and hepatitis B in preterm infants. Lower (~74%) protective antibody response to pertussis was independent of gestational age. PT-infants exhibited lower frequencies of CD4 T cells/dendritic cells/monocytes, increased plasma IL-10 levels and lower proliferation of central and effector memory T cells than in term-infants. Proliferative central memory response of FT-infants without anti-pertussis antibodies suggests protection from subsequent infection. Responder/non-responder PT-infants lacked immunological memory and could be infected with Bordetella. For hepatitis B, the recall response was gestational age-dependent and antibody status-independent. Humoral/cellular immune responses of PT-infants were dependent on the type of the immunogen. Preterm infants born before 32 weeks of gestation may need an extra dose of pentavalent vaccine for long lived robust immune response.


Subject(s)
Antigens/immunology , Gestational Age , Immunity , Infant, Premature/immunology , Vaccines, Combined/immunology , Antibodies, Bacterial/blood , Antibodies, Bacterial/immunology , Antibodies, Viral/blood , Antibodies, Viral/immunology , Biomarkers , Cytokines/blood , Female , Humans , Immunologic Memory , Immunophenotyping , India/epidemiology , Infant , Infant, Newborn , Leukocytes, Mononuclear/immunology , Leukocytes, Mononuclear/metabolism , Male , Public Health Surveillance , Vaccination
10.
Front Pediatr ; 9: 794637, 2021.
Article in English | MEDLINE | ID: mdl-35071137

ABSTRACT

Objective: To implement the Comprehensive Unit-based Safety Program (CUSP) in four neonatal intensive care units (NICUs) in Pune, India, to improve infection prevention and control (IPC) practices. Design: In this quasi-experimental study, we implemented CUSP in four NICUs in Pune, India, to improve IPC practices in three focus areas: hand hygiene, aseptic technique for invasive procedures, and medication and intravenous fluid preparation and administration. Sites received training in CUSP methodology, formed multidisciplinary teams, and selected interventions for each focus area. Process measures included fidelity to CUSP, hand hygiene compliance, and central line insertion checklist completion. Outcome measures included the rate of healthcare-associated bloodstream infection (HA-BSI), all-cause mortality, patient safety culture, and workload. Results: A total of 144 healthcare workers and administrators completed CUSP training. All sites conducted at least 75% of monthly meetings. Hand hygiene compliance odds increased 6% per month [odds ratio (OR) 1.06 (95% CI 1.03-1.10)]. Providers completed insertion checklists for 68% of neonates with a central line; 83% of checklists were fully completed. All-cause mortality and HA-BSI rate did not change significantly after CUSP implementation. Patient safety culture domains with greatest improvement were management support for patient safety (+7.6%), teamwork within units (+5.3%), and organizational learning-continuous improvement (+4.7%). Overall workload increased from a mean score of 46.28 ± 16.97 at baseline to 65.07 ± 19.05 at follow-up (p < 0.0001). Conclusion: CUSP implementation increased hand hygiene compliance, successful implementation of a central line insertion checklist, and improvements in safety culture in four Indian NICUs. This multimodal strategy is a promising framework for low- and middle-income country healthcare facilities to reduce HAI risk in neonates.

11.
BMC Public Health ; 20(1): 1559, 2020 Oct 16.
Article in English | MEDLINE | ID: mdl-33066763

ABSTRACT

BACKGROUND: Undernutrition among under five children in India is a major public health problem. Despite India's growth in the economy, the child mortality rate due to undernutrition is still high in both urban and rural areas. Studies that focus on urban slums are scarce. Hence the present study was carried out to assess the prevalence and determinants of undernutrition in children under five in Maharashtra, India. METHODS: A community-based cross-sectional study was conducted in 16 randomly selected clusters in two districts of Maharashtra state, India. Data were collected through house to house survey by interviewing mothers of under five children. Total 2929 mothers and their 3671 under five children were covered. Multivariate logistic regression analysis was carried out to identify the determinants of child nutritional status seperately in urban and rural areas. RESULTS: The mean age of the children was 2.38 years (±SD 1.36) and mean age of mothers was 24.25 years (± SD 6.37). Overall prevalence of stunting among children under five was 45.9%, wasting was 17.1 and 35.4% children were underweight. Prevalence of wasting, stunting and underweight were more seen in an urban slum than a rural area. In the rural areas exclusive breast feeding (p < 0.001) and acute diarrhea (p = 0.001) were associated with wasting, children with birth order 2 or less than 2 were associated with stunting and exclusive breast feeding (p < 0.05) and low maternal education were associated with underweight. Whereas in the urban slums exclusive breast feeding (p < 0.05) was associated with wasting, sex of the child (p < 0.05) and type of family (p < 0.05) were associated with stunting,and low income of the family (p < 0.05) was associated with underweight. CONCLUSIONS: Factors like sex of the child, birth order,exclusive breast feeding,economic status of the family, type of family,acute diarrhea and maternal education have influence on nutritional status of the child. Improvement of maternal education will improve the nutritional status of the child. Strategies are needed to improve the economic status of the community. TRIAL REGISTRATION: Trial registration number: CTRI/2017/12/010881 ; Registration date:14/12/2017. Retrospectively registered.


Subject(s)
Child Nutrition Disorders/epidemiology , Poverty Areas , Rural Population/statistics & numerical data , Urban Population/statistics & numerical data , Adult , Child, Preschool , Cross-Sectional Studies , Female , Humans , India/epidemiology , Infant , Male , Mothers/statistics & numerical data , Prevalence , Risk Factors , Socioeconomic Factors
12.
Indian Pediatr ; 57(10): 914-917, 2020 Oct 15.
Article in English | MEDLINE | ID: mdl-32729850

ABSTRACT

OBJECTIVE: To assess the epidemiological and clinical characteristics of pediatric inpatients with COVID-19, early in the pandemic. METHODS: Clinical and laboratory profile and outcomes were studied for children (aged 1 month - 18 years) presenting between 1 April, 2020 and 20 May, 2020 with positive nasopharyngeal swab for SARS-CoV-2 by RT-PCR. RESULTS: 50 children (56% male) with median (IQR) age of 6 (2-12) years were included. Majority (56%) were from families belonging to Kuppuswamy upper lower socioeconomic class. 45 (90%) had positive household contact, and 33 (66%) had overcrowding at home. 29 (58%) children were asymptomatic while 20 (40%) had mild symptoms. Fever, cough, and sore throat were the most common symptoms. High C-reactive protein levels were seen in 15 (30%) children. There was no mortality. CONCLUSION: The disease burden appears high in lower socio-economic group with majority having a positive household contact. Milder disease pattern in the pediatric age group is reiterated.


Subject(s)
Coronavirus Infections , Pandemics , Pneumonia, Viral , Adolescent , Asymptomatic Infections , Betacoronavirus , Blood Cell Count , COVID-19 , Child , Child, Preschool , Coronavirus Infections/diagnosis , Coronavirus Infections/epidemiology , Cross-Sectional Studies , Female , Humans , India/epidemiology , Infant , Male , Pneumonia, Viral/diagnosis , Pneumonia, Viral/epidemiology , Radiography, Thoracic , SARS-CoV-2 , Treatment Outcome
13.
PLoS One ; 15(5): e0231989, 2020.
Article in English | MEDLINE | ID: mdl-32369488

ABSTRACT

BACKGROUND AND OBJECTIVE: Birth weight and post-natal growth are important predictors of adult health. Preeclampsia (PE) is associated with low birth weight and may have long term effects on the health of the children. The current study aims to compare anthropometry and blood pressure between children of mothers with and without PE in an Indian cohort. METHODS: We studied children born to women with (PE; n = 211) and without preeclampsia (non-PE; n = 470) at Bharati Hospital, Pune, India. Anthropometry and blood pressure were measured in children at 3-7 years of age. Weight and height Z-scores were calculated using the WHO 2006 growth reference. Independent t-tests were used to compare means between the two groups, and associations between preeclampsia and child outcomes were analyzed using multiple linear regression, adjusting for potential confounders. RESULTS: Weight and height Z-scores (p = 0.04 and 0.008), and subscapular skinfold thickness (p = 0.03) were higher among children of PE compared with children of non-PE mothers. Systolic blood pressure was also higher in children of PE mothers (1.70 mmHg [95% CI 0.05, 2.90] p = 0.006). BMI and diastolic blood pressure did not differ between groups. In regression models adjusted for newborn weight and gestational age, current age and sex, and maternal height, BMI and socio-economic status, children of PE mothers had higher weight Z-score (0.27 SD [95%CI 0.06, 0.48] p = 0.01), height Z-score (0.28 SD [95%CI 0.09, 0.47] p = 0.005), and subscapular skinfold thickness (0.38 mm [95%CI 0.00, 0.76] p = 0.049). A trend for higher systolic blood pressure (1.59 mmHg [95%CI -0.02, 3.20] p = 0.053) in the children was also observed in the adjusted model. The difference in systolic blood pressure was attenuated after adjusting further for the child's weight and height (1.09 mmHg [95%CI -0.48, 2.67] p = 0.17). There was no evidence of differences in effects between boys and girls. CONCLUSION: Children of PE mothers were taller and heavier, and had higher systolic blood pressure, partly explained by their increased body size, than children of non-PE mothers. In utero exposure to preeclampsia may increase the risk of future cardiovascular disease.


Subject(s)
Birth Weight , Blood Pressure , Body Height , Pre-Eclampsia/physiopathology , Prenatal Exposure Delayed Effects/physiopathology , Blood Pressure Determination , Body Mass Index , Child , Child, Preschool , Cohort Studies , Female , Humans , India , Male , Maternal Age , Pregnancy , Risk Assessment
14.
J Med Virol ; 91(8): 1566-1570, 2019 08.
Article in English | MEDLINE | ID: mdl-31012488

ABSTRACT

Respiratory syncytial virus (RSV) causes significant infant mortality worldwide and a vaccine may be available soon. This study determined age-stratified anti-RSV antibody positivity (enzyme-linked immunosorbent assay [ELISA]) at Pune, India (cord blood-85 years). Antibody positivity declined from 100% at birth to 71.3% (3 months), and 0.7% (6 months). A significant rise was noted at 15 months (16%), 16 to 24 months (64.5%) and 4 years (95.2%) with concomitant IgM-anti-RSV positivity indicative of recent infection. Antibody decline was higher in infants born preterm than full-term. Across subsequent age groups including the elderly, antibody positivity was similar and comparable, suggestive of repeated exposure to the virus. Early protection/vaccination is essential for the infant population.


Subject(s)
Antibodies, Viral/blood , Respiratory Syncytial Virus Infections/epidemiology , Respiratory Syncytial Virus, Human/immunology , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Child , Child, Preschool , Female , Humans , India/epidemiology , Infant , Male , Middle Aged , Prospective Studies , Retrospective Studies , Seroepidemiologic Studies , Young Adult
15.
Contemp Clin Trials Commun ; 14: 100321, 2019 Jun.
Article in English | MEDLINE | ID: mdl-30899835

ABSTRACT

INTRODUCTION: We conducted a randomized, observer-blind, non-inferiority, parallel-group clinical study of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b conjugate (pentavalent) vaccination of infants in India. Goals were to determine whether the seropositivity rate after vaccination via disposable-syringe jet injector (DSJI) was non-inferior to that via needle and syringe (N-S), and to compare the safety of vaccination by the two methods. METHODS: Healthy children received a three-dose series of vaccine intramuscularly by DSJI or N-S beginning at 6-8 weeks of age. Immunoglobulin G antibody levels were measured by ELISA at 4-6 weeks after the third dose. The main secondary endpoint was safety, measured as injection site and systemic reactions. DISCUSSION: The study was stopped early out of caution beyond that specified in the protocol stopping criteria, after the Data Safety Committee noted a higher frequency of injection site reactions, especially moderate and severe, in the DSJI group. As a result, 128 subjects-DSJI group 61; N-S group 67-completed the study, rather than the 340 planned, and the study was not sufficiently powered to compare immunogenicity endpoints for the groups. Descriptive statistics indicate that seropositivity induced by vaccination with the DSJI was similar to that of N-S for all five antigens. Pentavalent vaccine includes whole-cell pertussis vaccine and an aluminum adjuvant, which may have contributed to the higher number of local reactions with the DSJI. The reactions caused no serious or long-term sequelae, and may be more acceptable in other populations or circumstances.US National Institutes of Health clinical trials identifier: NCT02409095.

16.
Vaccine ; 37(11): 1443-1448, 2019 03 07.
Article in English | MEDLINE | ID: mdl-30765170

ABSTRACT

BACKGROUND: Immunization of children with vaccines against Measles, Mumps, Rubella, and Varicella (MMRV) is practiced globally with varied recommendations. In India, measles vaccine is administered alone or as MMR at 9 months age. Varicella vaccine is not routinely used. Immunization age is a function of disappearance of maternal antibodies and natural exposure of the children to the pathogens. In view of the measles-WHO-initiative, we aimed to assess if the current immunization age for measles is still valid. In addition, the kinetics of IgG and IgM antibodies against rubella, mumps and varicella viruses was also examined. METHODS: This cross-sectional study was conducted at a tertiary care hospital in Pune, India. A total of 600 children, 150 each in 6-month/9-month (no vaccination) and 12-month/15-month (minimum 4 weeks post-measles-vaccine) cohorts were included. History of these infections and birth status (term/preterm) was recorded. All serum samples were screened for IgG-anti-MMRV-antibodies while IgG-positives were tested for specific IgM antibodies (ELISA). RESULTS: At 6-months, the prevalence of MMRV antibodies was 4.7%, 2.7%, 10.7%, 5.3% respectively depicting disappearance of maternal antibodies in majority of the children. Birth status did not influence antibody positivity. Despite vaccination at ∼9-months, >25% children were still susceptible to measles virus at the age of 12/15-months. The ratio of clinical:subclinical infections was 4:10 (measles) and 12:1 (varicella). All the mumps/rubella IgM positives (1 and 2 respectively) represented subclinical infections. CONCLUSION: Demonstration of early disappearance of maternal antibodies against MMRV viruses leading to the risk of these infections at an early age emphasize need for early immunization of Indian children. Suboptimal response to measles vaccine needs to be seriously addressed especially in view of the WHO's initiative for measles eradication.


Subject(s)
Antibodies, Viral/blood , Immunity, Maternally-Acquired , Immunoglobulin G/blood , Immunoglobulin M/blood , Measles/immunology , Mumps/immunology , Rubella/immunology , Age Factors , Cross-Sectional Studies , Female , Humans , India , Infant , Male , Measles-Mumps-Rubella Vaccine , Tertiary Care Centers/statistics & numerical data , Vaccination , World Health Organization
17.
J Viral Hepat ; 26(6): 757-760, 2019 06.
Article in English | MEDLINE | ID: mdl-30739364

ABSTRACT

The degree of transmission of hepatitis A virus (HAV) is inversely proportional to the socioeconomic status of a community. Serosurveys conducted at Pune, India during 1982-98 documented significant reduction in HAV exposure of paediatric, higher socioeconomic status (HSS) population. Anti-HAV positivity (ELISA) in age-stratified Pune population representing HSS and lower middle socioeconomic status (LMSS) (n = 1065) and infants till the age of 15 months (n = 690) was determined in 2017. Anti-HAV positivity in the LMSS population decreased significantly in 2017 while an increase was seen in the HSS category. The surprising rise in anti-HAV positivity in the HSS population reflected vaccine- and infection-induced antibodies while only infection-induced antibodies were present in the LMSS category. Lowest antibody prevalence in infants was at 12 months, the recommended age for hepatitis A vaccination. Improved hygiene and selective immunization practices impacted HAV exposure of the LMSS population. The data emphasize the need for hepatitis A vaccination irrespective of socioeconomic status.


Subject(s)
Hepatitis A Antibodies/blood , Hepatitis A Vaccines/administration & dosage , Hepatitis A/epidemiology , Social Class , Vaccination/statistics & numerical data , Adolescent , Adult , Child , Child, Preschool , Enzyme-Linked Immunosorbent Assay , Female , Hepatitis A/immunology , Hepatitis A virus , Humans , Hygiene , India/epidemiology , Infant , Infant, Newborn , Male , Middle Aged , Prevalence , Retrospective Studies , Young Adult
18.
BMC Public Health ; 18(1): 1111, 2018 Sep 11.
Article in English | MEDLINE | ID: mdl-30200933

ABSTRACT

BACKGROUND: Pneumonia is responsible for high morbidity and mortality amongst children under five year of age. India accounts for one-third of the total WHO South East Asia burden of under-five mortality. There is a paucity of epidemiological studies indicating the true burden of pneumonia. Identification of the risk factors associated with pneumonia will help to effectively plan and implement the preventive measures for its reduction. METHODS: It was a descriptive cross-sectional study conducted in 16 randomly selected clusters in two districts of Maharashtra state, India. All mothers of under-five children in the selected clusters were included. A validated pretested interview schedule was filled by trained field supervisors through the house to house visits.WHO definition was used to define and classify clinical pneumonia. Height and weight of children were taken as per standard guidelines. Quality checks for data collection were done by the site investigators and critical and noncritical fields in the questionnaire were monitored during data entry. For continuous variables mean and SD were calculated. Chi-square test was applied to determine the association between the variables. Level of significance was considered at 0.05. RESULTS: There were 3671 under five-year children, 2929 mothers in 10,929 households.Unclean fuel usage was found in 15.1% of households. Mean birth weight was 2.6 kg (SD;0.61). Exclusive breastfeeding till 6 months of age was practiced by 46% of mothers. Reported incidence of ARI was 0.49 per child per month and the reported incidence of pneumonia was 0.075 per child per year. It was not associated with any of the housing environment factors (p > 0.05) but was found to be associated with partial immunization (p < 0.05). Poor practices related to child feeding, hand hygiene and poor knowledge related to signs and symptoms of pneumonia amongst mother were found. CONCLUSIONS: Very low incidence of pneumonia was observed in Pune and Sangli districts of Maharashtra. Partial immunization emerged as a most important risk factor. Reasons for low incidence and lack of association of pneumonia with known risk factors may be a better literacy rate among mothers and better immunization coverage. TRIAL REGISTRATION: Registration number of the trial- CTRI/2017/12/010881 ; date of registration-14/12/2017.


Subject(s)
Pneumonia/epidemiology , Child, Preschool , Cross-Sectional Studies , Female , Humans , Immunization/statistics & numerical data , Incidence , India/epidemiology , Infant , Male , Risk Factors , Surveys and Questionnaires
19.
Hum Vaccin Immunother ; 13(1): 120-127, 2017 01 02.
Article in English | MEDLINE | ID: mdl-27629913

ABSTRACT

Multivalent combination vaccines have reduced the number of injections and therefore improved vaccine acceptance, timeliness of administration and global coverage. The hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib; Infanrix hexa™) vaccine, administered according to various schedules, is widely used for the primary vaccination of infants worldwide. In the current publication, we are presenting the immunogenicity and safety of 3 doses of DTPa-HBV-IPV/Hib vaccine when administered to Indian infants. 224 healthy infants (mean age 6.8 weeks) were vaccinated at 6-10-14 weeks (W) of age (n = 112) or 2-4-6 months (M) of age (n = 112). One month after the third vaccine dose, the seroprotection/seropositivity status against diphtheria, pertussis, tetanus, polio, hepatitis B and Hib antigens ranged from 98.6% to 100% in both groups. The vaccine response rate to the pertussis antigens ranged from 97% to 100%. Pain (6-10-14W group: 25.2%; 2-4-6M group: 13.4%) and fever (15.3% and; 15.2%, respectively) were the most frequently reported solicited local and general symptoms. Unsolicited adverse events were reported for 35.7% (6-10-14W group) and 22.3% (2-4-6M group) of subjects. No vaccine related serious adverse events were reported. In conclusion, the hexavalent DTPa-HBV-IPV/Hib vaccine was immunogenic and well tolerated, irrespective of the dosing schedule.


Subject(s)
Antibodies, Bacterial/blood , Antibodies, Viral/blood , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Haemophilus Vaccines/adverse effects , Haemophilus Vaccines/immunology , Hepatitis B Vaccines/adverse effects , Hepatitis B Vaccines/immunology , Immunization Schedule , Poliovirus Vaccine, Inactivated/adverse effects , Poliovirus Vaccine, Inactivated/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/pathology , Fever/epidemiology , Haemophilus Vaccines/administration & dosage , Healthy Volunteers , Hepatitis B Vaccines/administration & dosage , Humans , India , Infant , Pain/epidemiology , Poliovirus Vaccine, Inactivated/administration & dosage , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Combined/immunology
20.
J Clin Diagn Res ; 9(3): SD03-4, 2015 Mar.
Article in English | MEDLINE | ID: mdl-25954676

ABSTRACT

We report a case of an extremely low birth weight (ELBW) infant presenting with pulmonary hemorrhage (PH) in which we have given surfactant after an acute episode of bleeding with severe intractable hypoxemia. Surfactant replacement therapy showed improvement in Mean Airway Pressure (MAP) and oxygenation indices. Our case suggests that surfactant replacement therapy is useful in PH.

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