Remote biomonitoring of temperatures in mothers and newborns: design, development and testing of a wearable sensor device in a tertiary-care hospital in southern India.

OBJECTIVE: Newer technologies such as wearables, sensors, mobile telephony and computing offer opportunities to monitor vital physiological parameters and tackle healthcare problems, thereby improving access and quality of care. We describe the design, development and testing of a wearable sensor device for remote biomonitoring of body temperatures in mothers and newborns in southern India. METHODS: Based on client needs and technological requirements, a wearable sensor device was designed and developed using principles of 'social innovation' design. The device underwent multiple iterations in product design and engineering based on user feedback, and then following preclinical testing, a techno-feasibility study and clinical trial were undertaken in a tertiary-care teaching hospital in Bangalore, India. Clinical trial phases I and IIa for evaluation of safety and efficacy were undertaken in the following sequence: 7 healthy adult volunteers; 18 healthy mothers; 3 healthy babies; 10 stable babies in the neonatal care intensive unit and 1 baby with morbidities. Time-stamped skin temperature readings obtained at 5 min intervals over a 1-hour period from the device secured on upper arms of mothers and abdomen of neonates were compared against readings from thermometers used routinely in clinical practice. RESULTS: Devices were comfortably secured on to adults and neonates, and data were efficiently transmitted via the gateway device for secure storage and retrieval for analysis. The mean skin temperatures in mothers were lower than the axillary temperatures by 2°C; and in newborns, there was a precision of -0.5°C relative to axillary measurements. While occasional minimal adverse events were noted in healthy volunteers, no adverse events were noted in mothers or neonates. CONCLUSIONS: This proof-of-concept study shows that this device is promising in terms of feasibility, safety and accuracy (with appropriate calibration) with potential for further refinements in device accuracy and pursuit of further phases of clinical research for improved maternal and neonatal health.

Probiotics for Promoting Feed Tolerance in Very Low Birth Weight Neonates - A Randomized Controlled Trial.

OBJECTIVE: To measure the efficacy of a probiotic formulation on time to reach full enteral feeds in VLBW (very low birth weight) newborns. DESIGN: Blinded randomized control trial. SETTING: A tertiary care neonatal intensive care unit (NICU) in Southern India between August 2012 to November 2013. PARTICIPANTS: 104 newborns with a birth weight of 750-1499 g on enteral feeds. INTERVENTION: Probiotic group (n=52) received a multicomponent probiotic formulation of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii once a day at a dose of 1.25×109 CFU from the time of initiation of enteral feeds till discharge and the control group (n=52) received only breast milk. OUTCOME MEASURE: Time to reach full enteral feeds (150 mL/kg/day). RESULTS: The mean (SD) time to reach full enteral feeding was 11.2 (8.3) days in probiotic vs. 12.7 (8.9) in no probiotic group; (P=0.4), and was not significantly different between the two study groups. There was a trend towards lower necrotizing enterocolitis in the probiotic group (4% vs. 12%). CONCLUSION: Probiotic supplementation does not seem to result in significant improvement of feed tolerance in VLBW newborns.

Analgesic Efficacy of Oral Dextrose and Breast Milk during Nasopharyngeal Suctioning of Preterm Infants on CPAP: A Blinded Randomized Controlled Trial.

Continuous positive airway pressure (CPAP) requires nasopharyngeal suctioning for airway patency, which is painful. Other procedures have used breast milk and 25% dextrose as analgesics. We aimed to compare their analgesic efficacy during nasopharyngeal suctioning in preterm neonates on CPAP. In this blinded randomized controlled trial, babies received 25% dextrose or breast milk orally. Pain before, during and after was assessed using the Premature Infant Pain Profile (PIPP) score. Analysis was done for 40 babies. The mean PIPP score in the 25% dextrose group during the procedure was 11.25 ± 2.73 and 13.2 ± 2.55 (p = 0.02) with the intervention and without. In the breast milk group the PIPP score during the procedure was 11.35 ± 3.05 and 13.45 ± 3.27 (p = 0.04); this difference persisted even after the procedure. There was no significant difference between the interventions. Both interventions significantly reduce pain. The analgesic effect of breast milk was sustained.

Effectiveness of Onsite Nurse Mentoring in Improving Quality of Institutional Births in the Primary Health Centres of High Priority Districts of Karnataka, South India: A Cluster Randomized Trial.

BACKGROUND: In India, although the proportion of institutional births is increasing, there are concerns regarding quality of care. We assessed the effectiveness of a nurse-led onsite mentoring program in improving quality of care of institutional births in 24/7 primary health centres (PHCs that are open 24 hours a day, 7 days a week) of two high priority districts in Karnataka state, South India. Primary outcomes were improved facility readiness and provider preparedness in managing institutional births and associated complications during child birth. METHODS: All functional 24/7 PHCs in the two districts were included in the study. We used a parallel, cluster randomized trial design in which 54 of 108 facilities received six onsite mentoring visits, along with an initial training update and specially designed case sheets for providers; the control arm received just the initial training update and the case sheets. Pre- and post-intervention surveys were administered in April-2012 and August-2013 using facility audits, provider interviews and case sheet audits. The provider interviews were administered to all staff nurses available at the PHCs and audits were done of all the filled case sheets during the month prior to data collection. In addition, a cost analysis of the intervention was undertaken. RESULTS: Between the surveys, we achieved coverage of 100% of facilities and 91.2% of staff nurse interviews. Since the case sheets were newly designed, case-sheet audit data were available only from the end line survey for about 80.2% of all women in the intervention facilities and 57.3% in the control facilities. A higher number of facilities in the intervention arm had all appropriate drugs, equipment and supplies to deal with gestational hypertension (19 vs.3, OR (odds ratio) 9.2, 95% C.I 2.5 to33.6), postpartum haemorrhage (29 vs. 12, OR 3.7, 95% C.I 1.6 to8.3); and obstructed labour (25 vs.9, OR 3.4, 95% CI 1.6 to8.3). The providers in the intervention arm had better knowledge of active management of the third stage of labour (82.4% vs.35.8%, AOR (adjusted odds ratio) 10, 95% C.I 5.5 to 18.2); management of maternal sepsis (73.5% vs. 10.9%, AOR 36.1, 95% C.I 13.6 to 95.9); neonatal resuscitation (48.5% vs.11.7%, AOR 10.7, 95% C.I 4.6 to 25.0) and low birth weight newborn care (58.1% vs. 40.9%, AOR 2.4, 95% C.I 1.2 to 4.7). The case sheet audits revealed that providers in the intervention arm showed greater compliance with the protocols during labour monitoring (77.3% vs. 32.1%, AOR 25.8, 95% C.I 9.6 to 69.4); delivery and immediate post-partum care for mothers (78.6% vs. 31.8%, AOR 22.1, 95% C.I 8.0 to 61.4) and for newborns (73.9% vs. 32.8%, AOR 24.1, 95% C.I 8.1 to 72.0). The cost analysis showed that the intervention cost an additional $5.60 overall per delivery. CONCLUSIONS: The mentoring program successfully improved provider preparedness and facility readiness to deal with institutional births and associated complications. It is feasible to improve the quality of institutional births at a large operational scale, without substantial incremental costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02004912.

Availability of emergency neonatal care in eight districts of Karnataka state, southern India: a cross-sectional study.

BACKGROUND: Emergency Neonatal Care (EmNC) is an important service for the health and survival of newborns. The objective of our study was to assess the availability of emergency neonatal care services in the north-eastern region of Karnataka state in India. METHODS: We undertook a cross-sectional epidemiologic study in the year 2010. We assessed the provision of eight life-saving 'signal functions' (Comprehensive EmNC) or at least five 'signal functions' (Basic EmNC) by self-reporting through a structured questionnaire, coupled with verification by direct observation for presence of drugs and equipment in the prior three months. The assessment was undertaken in 443 government and 422 private healthcare facilities of eight districts of Karnataka. RESULTS: There was an average of 3.6 EmNC facilities available per 500,000 population for the entire region. Only three out of eight districts and 10 of 42 sub-districts in the region had the recommended [greater than or equal to 5] EmNC facilities per 500,000. Further, over 95 % of CEmNC facilities and 88 % of BEmNC facilities were within the private sector. About 80 % of government hospitals at district and sub-district levels did not have EmNC capability. CONCLUSIONS: This study demonstrates the feasibility of using a simple assessment tool to measure health facility availability of life-saving services for newborn care. EmNC availability was seen to be suboptimal at the regional, district and sub-district levels within the northern part of Karnataka state. There is a need to improve availability of emergency newborn care in health facilities, with special emphasis on equity at population level.

Comparison of efficacy of three devices of manual positive pressure ventilation: a mannequin-based study.

BACKGROUND: We compared the efficacy of and consistency in manual ventilation by trained healthcare professionals using three devices: self-inflating bag, flow-inflating bag, and T-piece resuscitator. METHODS: Prospective analytical study at a level III Neonatal unit of a tertiary care hospital. Forty participants (consultants, postgraduates, interns, and neonatal nurses - 10 each) manually ventilated a mannequin with the above three devices for three minutes each. This procedure was video recorded. The pressure delivered during the three minutes and the breath rates for the first minute, second minute, and third minute were analyzed. Descriptive statistics were used to describe the study population and group statistics were used for various parameters of interest. Factorial analysis of variance was conducted to determine the main effects of device and specialty of users. RESULTS: The mean (SD) peak inspiratory pressure of T-piece resuscitator was 16.5 (1.2), self-inflating bag (SIB) was 20.7 (4.4), and flow-inflating bag (AB) was 21.2 (5.0). The mean (SD) positive end expiratory pressure of T-piece resuscitator was 4.7 (0.9) cm of H2O and AB was 1.8 (1.7) cm of H2O. The maximum pressure delivered by T-piece resuscitator was 17.5, AB was 26.2, and SIB was 25.2 cm of H2O. Clinically appropriate breath rates were delivered using all of the devices. More effective breath rates were delivered using T-piece. There was no significant difference among the professional groups. CONCLUSIONS: The T-piece resuscitator provides the most consistent pressures and is most effective. Level of training has no influence on pressures delivered during manual ventilation.

Variability in survival of very low birth weight neonates in hospitals of India.

This prospective cohort study was conducted to evaluate variability in mortality of very low birth weight (VLBW) neonates during their birth hospitalization in different hospitals of India. A liveborn neonate was eligible for inclusion in the study if it was born or admitted in a participating hospital between 1st January and 31st December 2012 and weighed 1500g or less at birth. Neonates were given clinical care as per standard protocols. Standardized neonatal mortality ratio (SNMR) was calculated as the ratio of the observed mortality to the expected mortality. Expected mortality rate for each unit was calculated by adjusting for various prognostic factors at the time of birth or admission in the participating unit. Among 1345 neonates [mean birth weight: 1168 ± 240g, median gestation: 30wk (IQR: 28-32)] enrolled in the study 199 (14.8%) died before hospital discharge. Although variation in inter-hospital SNMR was statistically insignificant (P 0.49), 95% CI of SNMR of most hospitals was broad reaching level of clinical significance on both sides of line of equivalence. This indicates the need to establish an ongoing quality-improvement collaborative network to identify and adopt clinical practices associated with decreased mortality.

Topical anesthesia or oral dextrose for the relief of pain in screening for retinopathy of prematurity: a randomized controlled double-blinded trial.

OBJECTIVE: Compare efficacy of 0.5% proparacaine eye drops and oral 25% dextrose in reducing pain during screening for retinopathy of prematurity (ROP). PATIENTS AND METHODS: Double-blinded randomized controlled trial. Twenty eligible babies were randomized. Group I received 0.5% proparacaine eye drops at first ROP screening, while Group II received 25% dextrose orally. At second examination, babies received no intervention. Pain was assessed using Premature Infant Pain Profile (PIPP) score. RESULTS: The mean ( ± SD) PIPP during procedure in Group I were 15.5 ± 2.06 and 14 ± 2.4 at first and second screening (p = 0.259). The mean ( ± SD) PIPP in Group II were 14.2 ± 1. 8 and 14.9 ± 2.5 at the first and second screening (p = 0.428). Differences were not statistically significant. The PIPP scores of Group I and Group II at the first screening were also not significantly different (p = 0.165). CONCLUSION: ROP screening causes moderate to severe pain and neither proparacaine nor dextrose is an effective analgesic.

Efficacy of expressed breast milk in reducing pain during ROP screening--a randomized controlled trial.

OBJECTIVE: To assess the effectiveness of expressed breast milk (EBM) on neonatal pain during screening for retinopathy of prematurity (ROP). METHODS: Neonates who were on oral feeds undergoing ROP screening were included. Babies were randomized into intervention group (EBM + Standard practice) and control group. The standard practice is proparacaine, nesting and swaddling. Pain was assessed by PIPP scale, during and at 1 and 5 min after the procedure by the principal investigator who was blinded. RESULTS: The groups were similar in baseline characteristics. The group receiving EBM had significantly lower PIPP scores during the procedure 12.7 ± 1.69 compared to the control group 15.5 ± 1.78 (p < 0.05). The beneficial effect persisted at 1 min and 5 min after the procedure 6.20 ± 1.9 vs. 12.4 ± 2.54 (p ≤ 0.05) at 1 min; 3.2 ± 1.5 and 6.85 ± 2.4 (p < 0.05) at 5 min. CONCLUSION: Oral EBM significantly reduces pain during and after ROP screening.

Effect of early versus delayed cord clamping on hematological status of preterm infants at 6 wk of age.

OBJECTIVE: To compare the effect of early cord clamping (ECC) vs. delayed cord clamping (DCC) on hematocrit and serum ferritin at 6 wk of life in preterm infants. METHODS: This randomized controlled trial was conducted in the delivery room and neonatal intensive care unit of a tertiary hospital. One hundred preterm infants born between 30 (0)/7 and 36 (6)/7 wk were randomized to either early or delayed cord clamping groups. Parental informed consent was obtained prior to the delivery. In the ECC group, the cord was clamped immediately after the delivery of the baby and in the DCC group; the cord was clamped beyond 2 min after the baby was delivered. Hematocrit and serum ferritin at 6 wk of life were the primary outcomes. Incidence of anemia, polycythemia and significant jaundice were the main secondary outcomes. RESULTS: The mean hematocrit (27.3 ± 3.8 % vs. 31.8 ± 3.5 %, p value 0.00) and the mean serum ferritin (136.9 ± 83.8 ng/mL vs. 178.9 ± 92.8 ng/mL, p value 0.037) at 6 wk of age were significantly higher in the infants randomized to DCC group. The hematocrit on day 1 was also significantly higher in the DCC group (50.8 ± 5.2 % vs. 58.5 ± 5.1 %, p value 0.00). The DCC group required significantly longer duration of phototherapy (55.3 ± 40.0 h vs. 36.7 ± 32.6 h, p value 0.016) and had a trend towards higher risk of polycythemia. CONCLUSIONS: Delaying the cord clamping by 2 min, significantly improves the hematocrit value at birth and this beneficial effect continues till at least 2nd mo of life.

PAIN--perception and assessment of painful procedures in the NICU.

This prospective cross-sectional study was undertaken to determine the frequency of procedural pain among 101 neonates in the first 14 days of admission to a neonatal intensive care unit (NICU) in South India and to study the perception of health-care professionals (HCP) about newborn procedural pain. The total number of painful procedures was 8.09 ± 5.53 per baby per day and 68.32 ± 64.78 per baby during hospital stay. The most common procedure was heel prick (30%). The HCP were administered a questionnaire to assess their perception of pain for various procedures. Procedures were perceived as more painful by nurses than by doctors. Chest tube placements and lumbar puncture were considered most painful. This study shows that the neonates in the NICU in developing countries experience many painful procedures. The awareness about this intensity of pain should provide a valuable tool in formulating pain-reduction protocols for management in low resource settings.

Breast milk zinc transfer and early post-natal growth among urban South Indian term infants using measures of breast milk volume and breast milk zinc concentrations.

Zinc (Zn) deficiency in infancy and early childhood is of public health concern in developing countries. This study aimed to longitudinally assess Zn intake of urban South Indian term infants in the first 6 months of life using measures of breast milk (BM) volume and BM Zn concentrations and, additionally, to study the effect of BM Zn intake on infant length and weight gain. BM intake by the deuterium dilution technique, BM Zn concentration at months 1, 3 and 6, as well as serum Zn level at months 3 and 6 were assessed in 50 mother-infant pairs. BM intake significantly declined from 627 mL day(-1) at month 1 to 608 mL day(-1) at month 6 (P < 0.01). BM Zn concentration and intake significantly declined from month 1 to month 6 (P < 0.001 for both). Mean infant serum Zn level at months 3 and 6 were 93.0 ± 27.1 and 99.6 ± 30.1 µg dL(-1), respectively. Infant BM Zn intake at months 1 and 3 was not associated with the weight and length gain between 1-3 and 3-6 months, respectively. Zn intake from BM, maternal BM Zn content and serum Zn levels were not significantly different between small-for-gestational age and appropriate-for-gestational age infants. Therefore, among urban south Indian term infants less than 6 months of age, BM Zn intakes were low, owing to low volumes of BM intake, despite BM Zn concentrations being in the normal range. Promotion of breastfeeding and thereby increasing the volumes of milk produced is a first important step towards improving Zn intake among infants.

High folate and low vitamin B-12 intakes during pregnancy are associated with small-for-gestational age infants in South Indian women: a prospective observational cohort study.

BACKGROUND: Folic acid supplementation in those with a low vitamin B-12 intake or status may have adverse effects. These effects are unknown with regard to birth outcome in pregnant Indian women who are routinely supplemented with high doses of folic acid. OBJECTIVE: The objective was to examine the association of unbalanced vitamin B-12 and total folate (folic acid supplement + dietary folate) intakes during pregnancy with outcomes in small-for-gestational-age (SGA) infants. DESIGN: This was a prospective observational cohort study of 1838 pregnant women in South India. Low intake of dietary vitamin B-12 in the presence of high total folate intake was examined as the ratio of vitamin B-12 intake to total folate intake. RESULTS: The inadequacy of vitamin B-12 intake (<1.2 µg/d) assessed by a food-frequency questionnaire in the first, second, and third trimesters of pregnancy was 25%, 11%, and 10%, respectively. Multivariate log binomial regression showed that low vitamin B-12 and folate intakes in the first trimester were independently associated with a higher risk of SGA. In a subgroup of women with high supplemental folic acid intakes in the second trimester, those with the lowest tertile of vitamin B-12:folate ratio had a higher risk of SGA outcome than did those in the highest tertile (adjusted RR: 2.73; 95% CI: 1.17, 6.37). A similar trend was observed in the analysis of blood micronutrient status in a random subset (n = 316) of the sample. CONCLUSIONS: These findings suggest that, in addition to vitamin B-12 and folate deficiencies alone, there may be adverse birth outcomes associated with unbalanced vitamin B-12 and folate intakes or status during pregnancy. These findings have important implications for the antenatal B vitamin supplementation policy in India. This trial was registered at the Clinical Trial Registry of India as 2013/07/005342.

Comparison of New Ballards score and Parkins score for gestational age estimation.

This prospective analytical study was done to compare the accuracy of New Ballards score (NBS) and Parkins score (PS) in assessing the gestational age (GA) in newborns. The GA of 284 babies was assessed by the NBS and PS within 24 hours of birth. The two methods of assessment were compared using the Bland Altmann Plot. The mean difference between the two measurements was 1.530576. 95% of the values lay within the limits of agreement which are -1.82982 and 4.890974. The two methods are found to be in acceptable agreement. Parkins score enables us to easily assess the gestational age of babies within ±12 days, especially in sick and preterm babies.

Expressed breast milk vs 25% dextrose in procedural pain in neonates, a double blind randomized controlled trial.

OBJECTIVE: To compare the effect of expressed breast milk (EBM), 25% dextrose (25 D) and sterile water (SW) on procedural pain in neonates as assessed by the premature infant pain profile (PIPP), changes in heart rate (HR), oxygen saturation (SpO2) and duration of crying. DESIGN: Prospective, double blind, randomized controlled trial. SETTING: Postnatal ward of a tertiary-care hospital. PARTICIPANTS: 210 babies who required venipuncture for blood sampling and who were on oral feeds were recruited into the study after parental informed consent. METHODS: The enrolled babies were randomized into intervention groups (EBM, 25% dextrose) and control group (sterile water). Two ml of test solution was given to baby by paladay (a traditional cup with a spout) 2 min before venipuncture. The face and crying of baby were video graphed by an independent, blinded observer. The facial response to pain (brow bulge, eye squeeze, nasolabial furrow) was analysed from the video. Maximum HR and minimum SpO2 were recorded during, and 1, 3 and 5 min after venipuncture by another blinded observer. OUTCOME VARIABLE: PIPP score, HR, SpO2 and crying time at 0/1/3/5 min after sampling. RESULTS: 160 babies were considered for final analysis with 50 in 25 D, 62 in EBM and 48 in SW group. The mean PIPP score in the 3 groups were 5.22, 6.84 and 11.22 at 0-30 sec after venipuncture; 4.52, 6.34, and 10.88 at 1-1½ min; 3.96, 6.15 and 9.35 at 3-3½ min; and 3.12, 4.68 and 7.83 at 5-5½ min; respectively (P<0.001). The median crying time was 10, 37.5 and 162 seconds in 25 D, EBM and SW groups, respectively (P<0.001). CONCLUSIONS: EBM significantly reduces procedural pain in neonates though to a lesser extent as compared to 25% dextrose.

Potential factors related to waist circumference in urban South Indian children.

OBJECTIVES: To identify important factors (linked to lifestyle, eating and sedentary behaviors) relating to waist circumference among urban South Indian children aged 3 to 16 years. DESIGN: Cross sectional. SETTING: Urban schools of Bangalore, from August 2008 to January 2010. PARTICIPANTS: 8444 children; 4707 children aged 3-10 years and 3737 children aged 10-16 years. METHODS: Data were collected on the frequency of consumption of certain foods, physical activity patterns, sedentary habits at home, sleep duration and behaviors such as habits of snacking, skipping breakfast, eating in front of television and frequency of eating out. Simple linear regression analysis of waist circumference on various food items, physical activity, behavior and parental BMI were performed. A path model was developed to identify potential causal pathways to increase in waist circumference. RESULTS: Increased consumption of bakery items, non vegetarian foods, increased television viewing, decreased sleep duration, eating while watching television, snacking between meals, family meals, skipping breakfast (in older children), and parental BMI were found to be related to waist circumference. Older children possibly under-reported their intake of unhealthy foods, but not behaviors. CONCLUSIONS: This study identified potential behaviors related to waist circumference in urban school children in India. Longitudinal studies with better measures of morbidity and adiposity are warranted in order to derive casual relationships between various determinants and waist circumference.

Waist circumference and waist for height percentiles in urban South Indian children aged 3-16 years.

OBJECTIVES: To develop age and gender specific waist circumference references for urban Indian children aged 3 -16 years. DESIGN: Cross-sectional study. SETTING: Urban preschools and schools of Bangalore. PARTICIPANTS: 9060 children (5172 boys and 3888 girls) in the age group of 3-16 years. METHODS: Weight, height, and waist circumference were measured using standard anthropometric methodology. Percentiles for waist circumference and Waist/height ratio (W/Ht) for each age and gender were constructed and smoothed using the LMS method. RESULTS: Mean waist circumference increased with age for both girls and boys. The upper end of curve in boys continued to increase, whereas in the girls it tended to plateau at 14 years. The waist circumference of the Indian children from the present study was higher than age and sex matched European children. The proportion of children with W/Ht ratio greater than 0.5 decreased as their age increased. CONCLUSIONS: These curves represent the first waist and waist height ratio percentiles for Indian children and could be used as reference values for urban Indian children. We suggest that for a start, the 75th percentile of waist circumference from this study be used as an action point for Indian children to identify obesity (as a tautological argument), while retaining the cut-off of 0.5 for the W/Ht ratio; however this underlines the need to derive biologically rational cut-offs that would relate to different levels of risk for adult cardiovascular disease.

Evaluation of the immunogenicity and safety of an indigenously developed DTwP-Hib tetravalent combination vaccine (Shan 4) with EasyFourTM in Indian infants administered per EPI schedule: a phase III trial.

The study was planned to assess and compare immunogenicity and safety of an indigenous DTPw-Hib combination vaccine (Shan 4) with EasyFour, the available DTwP-Hib vaccine in India. Overall 210 healthy infants, six to eight weeks of age, were randomized to receive three doses of either Shan 4 or EasyFour at 6, 10 and 14 weeks of age. Antibodies were analyzed prior to and four to six weeks post third vaccine dose. Solicited and unsolicited local and systemic events in the follow up period after each dose were recorded. Post vaccination 100% of the infants in Shan 4 and EasyFour groups had seroprotective concentrations of Anti PRP-T IgG antibodies, IgG anti-diphtheria toxoid antibodies and IgG anti-tetanus toxoid antibodies. Following third dose of vaccination 86.99% subjects in the Shan 4 group and 73.85% subjects in the EasyFour group seroconverted for anti-pertussis antibody titres. Two Serious Adverse Events (SAE s) were reported during the course of the study, all unrelated to the respective vaccine administered. Most commonly reported adverse events in both the groups were pain at injection site, mild fever (<103°F) and minor swelling at injection site. The study proved that Shan 4 was safe and immunogenic compared to the available licensed vaccine.

The relationship between maternal physical activity during pregnancy and birth weight.

INTRODUCTION: Earlier studies in India have demonstrated an inverse relationship between physical activity and birth weight in rural women who had high levels of physical activity related to agricultural and domestic activities. There are no data on urban Indian women from a wide range of socio-economic backgrounds with varying levels of physical activity. This study assessed the role of different domains of physical activity during pregnancy and its relation to birth weight. METHODS: Data on maternal anthropometry and maternal physical activity level were collected at the 1st trimester (baseline), the 2nd trimester and the 3rd trimester of pregnancy. Birth weight for 546 live born babies was measured immediately after delivery. RESULTS: The time spent in sedentary activities (median "cut-off" of 165 min/d) was significantly associated with maternal body weight in the first trimester of pregnancy (51.2 kg vs. 54.1 kg, p < 0.001). Women in the highest tertile of physical activity level in the 1st trimester were 1.58 times (95% CI: 1.02-2.44) more likely of having a baby in the lowest tertile of birth weight with reference to the first tertile. This significant association continued after adjustment for maternal weight and energy intake. CONCLUSION: The present study shows that physical activity in the first trimester is associated with low birth weight in Indian babies.