Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults.

AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.

SCOPE: Surveillance of COVID-19 in pregnancy- results of a multicentric ambispective case-control study on clinical presentation and maternal outcomes in India between April to November 2020.

OBJECTIVE: To determine the clinical manifestations, risk factors, treatment modalities and maternal outcomes in pregnant women with lab-confirmed COVID-19 and compare it with COVID-19 negative pregnant women in same age group. DESIGN: Multicentric case-control study. DATA SOURCES: Ambispective primary data collection through paper-based forms from 20 tertiary care centres across India between April and November 2020. STUDY POPULATION: All pregnant women reporting to the centres with a lab-confirmed COVID-19 positive result matched with controls. DATA QUALITY: Dedicated research officers extracted hospital records, using modified WHO Case Record Forms (CRF) and verified for completeness and accuracy. STATISTICAL ANALYSIS: Data converted to excel files and statistical analyses done using STATA 16 (StataCorp, TX, USA). Odds ratios (ORs) with 95% confidence intervals (CI) estimated using unconditional logistic regression. RESULTS: A total of 76,264 women delivered across 20 centres during the study period. Data of 3723 COVID positive pregnant women and 3744 age-matched controls was analyzed. Of the positive cases 56·9% were asymptomatic. Antenatal complications like preeclampsia and abruptio placentae were seen more among the cases. Induction and caesarean delivery rates were also higher among Covid positive women. Pre-existing maternal co-morbidities increased need for supportive care. There were 34 maternal deaths out of the 3723(0.9%) positive mothers, while covid negative deaths reported from all the centres were 449 of 72,541 (0·6%). CONCLUSION: Covid-19 infection predisposed to adverse maternal outcomes in a large cohort of Covid positive pregnant women as compared to the negative controls.

A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India.

BACKGROUND: This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca. METHODS: This participant-blind, observer-blind study randomised participants 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (ChAdOx1 nCoV-19) (immunogenicity/reactogenicity cohort) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort). The study participants were enrolled from 14 hospitals across India between August 25 and October 31, 2020. Two doses of study products were given 4 weeks apart. The primary objectives were to demonstrate non-inferiority of SII-ChAdOx1 nCoV-19 to AZD1222 in terms of geometric mean titre (GMT) ratio of anti-SARS-CoV-2 spike IgG antibodies 28 days after the second dose (defined as lower limit of 95% CI >0·67) and to determine the incidence of serious adverse events (SAEs) causally related to SII-ChAdOx1 nCoV-19. The anti-spike IgG response was assessed using a multiplexed electrochemiluminescence-based immunoassay. Safety follow-up continued until 6 months after first dose. Trial registration: CTRI/2020/08/027170. FINDINGS: 1601 participants were enrolled: 401 to the immunogenicity/reactogenicity cohort and 1200 to the safety cohort. After two doses, seroconversion rates for anti-spike IgG antibodies were more than 98·0% in both the groups. SII-ChAdOx1 nCoV-19 was non-inferior to AZD1222 (GMT ratio 0·98; 95% CI 0·78-1·23). SAEs were reported in ≤ 2·0% participants across the three groups; none were causally related. A total of 34 SARS-CoV-2 infections were reported; of which 6 occurred more than 2 weeks after the second dose; none were severe. INTERPRETATION: SII-ChAdOx1 nCoV-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile. Pharmacovigilance should be maintained to detect any safety signals. FUNDING: SIIPL funded the contract research organisation and laboratory costs, while the site costs were funded by the Indian Council of Medical Research. The study vaccines were supplied by SIIPL and AstraZeneca.

Nurturing Care Interventions for Realizing the Development Potential of Every Child: From Pilot to Scale Up in Maharashtra.

The WHO-UNICEF nurturing care framework (NCF) for early childhood development provides a roadmap for action, focusing on pregnancy and the first three years of life. It emphasizes the need to invest in capacity building and empowerment of service providers, families and communities to create a conducive environment that promotes child development. We describe our experience of implementing nurturing care interventions, beginning with a pilot project in Maharashtra covering a population of 10000 to and scaling it up to a model called Aarambh (the beginning), catering to a population of 1,500,000. Opportunities available within the existing services across multiple sectors were used; Integrated Child Development Services (ICDS) scheme, the health sector, and others. It utilized multiple approaches for promoting NCF within families; home visits by frontline workers (FLWs), mothers' meetings, growth monitoring and promotion sessions, and community-based events as key opportunities. Joint training for FLWs, establishing supervisors of FLWs as their trainers, and an interactive training curriculum were critical elements identified for the success of the model. An environment of appreciation for the FLWs and their supervisors helped build their confidence and helped them own the interventions.

Validating the MUAC (Mid-upper arm circumference) Cut-off for Detection of Severe Acute Malnutrition in Children Aged 6-59 Months in Rural Maharashtra.

OBJECTIVE: To review the Mid-upper arm circumference (MUAC) cut-off currently being used to identify Severe Acute Malnutrition (SAM) as currently defined using Weight-for-Height. METHODS: Cross-sectional study conducted in 24 villages of a Primary Health Centre in Wardha district of Maharashtra among 2650 children between the ages of 6 to 59 months. RESULTS: For identifying SAM, sensitivity of MUAC was 23.5% and specificity was 99.7% for cut-off <11.5 cm. Using Youden index, best Mid-upper arm circumference cut-off point to identify SAM was <13 cm with sensitivity of 74.5% and specificity of 92.7%. Using Receiver operating characteristics curve, best MUAC cut-off point was 12.8 cm with 74.5% sensitivity and 92.7% specificity. Area under curve was 0.88 (95%CI: 0.85-0.91). CONCLUSION: The current MUAC cut-off of <11.5 cm for detecting SAM needs to be increased to ensure that children, who need referral for management of malnutrition, are not missed.

Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants.

BACKGROUND: A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency. METHODS: This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards. RESULTS: Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil® group was causally related. CONCLUSION: The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®. TRIAL REGISTRATION NUMBER: Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].

Efficacy and tolerability of treatment with single doses of diethylcarbamazine (DEC) and DEC plus albendazole (ABZ) for three consecutive years in lymphatic filariasis: a field study in India.

Lymphatic filariasis (LF) affects 73 countries, causes morbidity and impedes socioeconomic development. We had found no difference in safety and micro (Mf) and macro filarial action of single-dose diethylcarbamazine (DEC) and DEC + albendazole (ABZ) in an F01 study done in India (year 2000). There was a programmatic need to evaluate safety and efficacy of multiple annual treatments (F02). Subjects (155) from the F01 study, meeting inclusion-exclusion criteria, were enrolled in F02 and treated with further two annual doses of DEC or DEC + ABZ. Efficacy was evaluated for Mf positivity by peripheral smear (PS) and nucleopore (NP) filter, circulating filarial antigen (CFA) and filarial dance sign (FDS) positivity and Mf count at yearly follow-up. Safety was assessed for 5 days after drug administration. Total of 139 subjects evaluated for efficacy (69 DEC and 70 DEC + ABZ group). Mf positivity prevalence declined progressively by 95% (PS), 66% (NP), and 95% (PS) and 86% (NP); CFA positivity prevalence declined by 15% and 9%; FDS by 100% each; Mf count declined by 75.5 and 76.9% with three annual treatment of DEC and DEC + ABZ, respectively. Addition of ABZ did not show any advantage over DEC given as three annual rounds for LF. DEC and DEC + ABZ were well tolerated. There was no correlation between result of CFA and FDS, (both claimed to be indicative of adult worm). Analysis of published studies and our data indicate that macrofilaricidal effect of DEC/DEC + ABZ may be seen in children and not adults, with three or more annual dosing.

Perceptions of nonsurgical permanent contraception among potential users, providers, and influencers in Wardha district and New Delhi, India: Exploratory research.

BACKGROUND: New permanent contraceptive methods are in development, including nonsurgical permanent contraception (NSPC). OBJECTIVE: In the present study, perceptions of NSPC in India among married women, married men, mothers-in-law, providers, and health advocates in Eastern Maharashtra (Wardha district) and New Delhi were examined. METHODS: We conducted semi-structured interviews with 40 married women and 20 mothers-in-law; surveys with 150 married men; and focus group discussions with obstetrics/gynecology providers and advocates. Transcripts were coded and analyzed using a grounded theory approach, where emerging themes are analyzed during the data collection period. RESULTS: The majority of female respondents expressed support of permanent contraception and interest in NSPC, stating the importance of avoiding surgery and minimizing recovery time. They expressed concerns about safety and efficacy; many felt that a confirmation test would be necessary regardless of the failure rate. Most male respondents were supportive of female permanent contraception (PC) and preferred NSPC to a surgical method, as long as it was safe and effective. Providers were interested in NSPC yet had specific concerns about safety, efficacy, cost, uptake, and government pressure. They also had concerns that a nonsurgical approach could undermine the inherent seriousness of choosing PC. Advocates were interested in NSPC but had concerns about safety and potential misuse in the Indian context. CONCLUSION: Although perceptions of NSPC were varied, all study populations indicated interest in NSPC. Concerns about safety, efficacy, appropriate patient counseling, and ethics emerged from the present study and should be considered as NSPC methods continue to be developed.

Role of probiotics VSL#3 in prevention of suspected sepsis in low birthweight infants in India: a randomised controlled trial.

OBJECTIVES: To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants. DESIGN: Randomised, double-blind, placebo-controlled trial. SETTING: Community setting in rural India. PARTICIPANTS: LBW infants aged 3-7 days. INTERVENTIONS: Infants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months. MAIN OUTCOME MEASURE: Possible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians. RESULTS: 668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063). CONCLUSIONS: Daily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants. TRIAL REGISTRATION NUMBER: The study is registered at the Clinical Trial Registry of India (CTRI/2008/091/000049).

A comparative clinical study to assess safety and reactogenicity of a DTwP-HepB+Hib vaccine.

Hepatitis B and Haemophilus influenzae type b (Hib) infections are major public health problems in developing countries, including India. Hence, combination vaccines containing DTwP, recombinant hepatitis B and Hib conjugate vaccines have been developed. Here, we report a Phase IV study which assessed safety and reactogenicity of a new DTwP-HepB+Hib vaccine. Three doses of DTwP-HepB+Hib vaccine (Pentavac, Serum Institute of India Ltd) or Tritanrix-HB+Hib (GlaxoSmithKline Beecham) were administered to infants at 6, 10 and 14 weeks of age in 2:1 ratio. The subjects were followed till one month after the third dose for safety assessment. Adverse events were captured in structured diaries and physical examinations were performed on each visit. The study was conducted in 1510 infants. Both vaccines caused injection site local and systemic reactions and the incidence was similar in both the groups. The incidence of local solicited reactions was: tenderness 35.9 %-33.6 %; redness 18.1 %-17.2 %; swelling 23.7 %-22.4 %; induration 12.8 % -13.7 %. The percentage of systemic solicited reactions were: diarrhea 2.2 %-2.2 %; drowsiness 3.3 %-3.4 %; fever 14.0 %-11.2 %; irritability 28.1 %-25.4 %; loss of appetite 6.6 %-5.6 %; persistent crying 17.7 %-15.7 %; vomiting 3.5 %-3.0 %. No serious adverse event was caused by the vaccines. The new DTwP-HepB+Hib combination vaccine showed similar safety profile to that of an imported vaccine in Indian infants.

Interest in nonsurgical female permanent contraception among men in Portland, Oregon and eastern Maharashtra, India.

OBJECTIVE: We examined the men's attitudes and perceptions toward the concept of female nonsurgical permanent contraception (NSPC) or novel approaches to permanent contraception (PC) that do not require incisions or surgical equipment/hysteroscope. STUDY DESIGN: Cross-sectional survey of married/partnered men in Portland, OR, and rural eastern Maharashtra, India. Descriptive analysis was performed. RESULTS: In India (N=150), most men (80%) anticipated that their partners would undergo PC in the future, compared to 30% in Portland (N=170). About a third (39.6% in India, 82% in Portland) reported being uncomfortable with PC for partners due to the need for surgery. Most men (85% in India, 82% in Portland) expressed a preference for a hypothetical new method of female NSPC over surgery, if safe and effective. CONCLUSION: Most men sampled in two diverse settings expressed interest in NSPC for women. IMPLICATIONS: Men's perceptions of new female contraceptive methods are important to the contraceptive development process. Men may find a safe and effective nonsurgical method of permanent female contraception more acceptable than surgical PC.

Where and how breastfeeding promotion initiatives should focus its attention? A study from rural wardha.

BACKGROUND: In India, the practice of breastfeeding is almost universal, but initiation of breastfeeding is generally quite late and colostrum is discarded. Integrated Management of Neonatal and Childhood Illness (IMNCI) strategy recommended systematic assessment of breastfeeding and emphasized counseling of the mother on proper positioning and attachment of infant to the breast. OBJECTIVE: To assess breastfeeding among mothers of below six months children in rural Wardha. MATERIALS AND METHODS: The present cross-sectional study was undertaken in surrounding 23 villages of Kasturba Rural Health Training Center (KRHTC), Anji. Two Auxiliary Nurse Midwives (ANMs) trained in IMNCI paid house visits to 99 mothers during the study period and undertook the assessment of breastfeeding using IMNCI assessment form for young infants. Auxiliary Nurse Midwives observed and recorded the positioning and attachment of infant to the breast as per IMNCI guidelines. The data were entered and analyzed using Epi_Info (version 6.04d) software package. RESULTS: Most of the deliveries 94 (94.9%) took place in the healthcare facilities. Majority 61 (61.6%) newborn babies had received breastfeeding within half an hour. About half of the mothers had any of the feeding problems like feeding less than eight times in 24 h, giving any other food or drinks or is low weight for age. Significantly more mothers with feeding problems had problems in positioning and attachment of infant to the breast as compared with those mothers who did not have any feeding problems. CONCLUSIONS: In the settings, where practice of institutional delivery is high, the staff of healthcare facility should ensure education of the mothers regarding position and attachment of infant to the breast before discharge from the healthcare facility. At the village level, Village Health Nutrition Day (VHND) can be utilized for health education of future mothers and support for the breastfeeding mothers. The IMNCI assessment form for young infant should also include assessment of positioning of infant.

An evaluation of ROME Camp: forgotten innovation in medical education.

BACKGROUND AND OBJECTIVES: Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, India's first rural medical institute, has been implementing its community-based public health teaching with the aim of building a physician workforce for the rural poor. For the past four decades, the MGIMS has organized and run the Re-orientation of Medical Education (ROME) camp for final year medical undergraduates at one of the rural centres of the department of Community Medicine. The objectives of the present study were to learn students' perceptions of the value and effectiveness of various components of the ROME camp and learn the factors they perceive facilitate and inhibit learning. METHODS: A mixed-method research design of quantitative (survey) and qualitative (force field analysis) methods was used. The study participants were all 61 of the final year medical undergraduates participating in the ROME camp in 2008. The quantitative data was analyzed using SPSS software package and summative content analysis of the qualitative data was undertaken. RESULTS: Students were generally very positive about all aspects of the camp and its component parts. The greatest consensus (88.9%, on a 0 to 100% scale) was for the contribution to student learning of the visit to the Primary health centre and Sub-centre, as offering direct exposure and interaction with the village-level service providers. There was poorer consensus for students' involvement with the field-based clinics, as this was felt by some not to contribute significantly to their understanding of socio-economic and environmental factors related to cases (78.8%) and their ability to diagnose health problems in resource poor settings (76.5%). The major strength of the camp was felt to be its exposure visits and hands-on experiences in surveys and interaction with village-level health care providers. Students reported poor interactions with teachers in some educational sessions, including the field-based clinics and classes on theories of national health programs. CONCLUSIONS: The curriculum of the ROME camp was generally well regarded by students, but based on their views it should emphasize interactive theory sessions. The ROME scheme can be revitalized in all medical colleges as it is an effective practical approach for teaching public health principles and practice to medical students.

Childhood morbidity, household practices and health care seeking for sick children in a tribal district of Maharashtra, India.

OBJECTIVES: To find out the magnitude of childhood morbidities, health care seeking behavior and explore the status of 'some desired practices' at household level during episodes of illness in two tribal blocks of Chandrapur district. MATERIALS AND METHODS: The present explanatory mixed-method design of quantitative (survey) and qualitative (focus group discussions, FGDs )methods was undertaken in nine Primary health centers of Warora and Bhadrawati blocks in Chandrapur district. The information of 2,700 under-five children on morbidity, health care seeking behavior and some desired practices at household level was collected by paying home visits and using pre-designed and pre-tested questionnaire. The data was entered and analyzed by using SPSS 12.0.1 and C sample program of epi_info (version 6.04d) software package. The conventional content analysis of FGD data was undertaken. RESULTS: The prevalence of morbidities was high among newborns and children. About 1,811 (67%) children had at least one of the morbidities. Private health care providers and village level faith healers were preferred for seeking treatment of newborn danger sings and childhood morbidities. The status of some desired household practices such as frequent feeding and giving extra fluid to drink during episodes of illness was poor. CONCLUSIONS: In conclusion, considering high prevalence of child morbidities and poor status of some desired household practices of caregivers at household level for sick children, household and community IMNCI strategy needs to be implemented to promote child health and nutrition. Apart from this, health care delivery at village level should be strengthened.

Intestinal parasites prevalence and related factors among school children in the rural area of central India.

A cross sectional study was conducted to determine the prevalence of intestinal parasitic infections and its epidemiological correlates among rural Indian school going children and to find out the effect of hygiene education on personal hygiene of school children at village Karanji (Kaji) in Wardha district of central India. Out of 172, 87 (50.6%) boys and 85 (49.4%) girls were examined. The mean age of the school children was 10.37 +/- 2.71. The prevalence of intestinal parasite infection was 7.56%. The prevalence was significantly high among barefoot children (OR = 8.99; 95% CI: 2.14 - 43.49) followed by those having poor hand washing practices (OR = 4.90; 95% CI: 1.30 - 20.01), not using sanitary latrine (OR = 2.49; 95% CI: 0.6 - 11.91)) and dirty untrimmed nails (OR = 1.98; 95% CI: 0.56 - 7.04). One month after hygiene education, there was significant improvement in the key personal hygiene behavior (p < 0.05). The proportion of children having practice of hand washing with soap after defecation significantly improved. Health education on personal hygiene to the school children was effective for behavior change. A multisectoral control approach and hygiene education will help health authorities in strategy of control programs for intestinal parasites among school going children.

Acute childhood morbidities in rural Wardha: some epidemiological correlates and health care seeking.

BACKGROUND: In India, common morbidities among children under 3 years of age are fever, acute respiratory infections, diarrhea. Effective early management at the home level and health care-seeking behavior in case of appearance of danger signs are key strategies to prevent the occurrence of severe and life-threatening complications. OBJECTIVES: To find out the prevalence of acute child morbidities, their determinants and health-seeking behavior of the mothers of these children. SETTING AND DESIGN: The cross-sectional study was carried out in Wardha district of central India. MATERIAL AND METHODS: We interviewed 990 mothers of children below 3 years of age using 30-cluster sampling method. Nutritional status was defined by National Center for Health Statistics (NCHS) reference. Composite index of anthropometric failure (CIAF) was constructed. Hemoglobin concentration in each child was estimated using the 'filter paper cyanm ethemoglobin method.' Using World Health Organization guidelines, anemia was defined as hemoglobin concentration less than 110 g/L. Post-survey focus group discussions (FGDs) were undertaken to bridge gaps in information obtained from the survey. STATISTICAL ANALYSIS: The data was analyzed by using SPSS 12.0.1 software package. Chi-square was used to test the association, while odds ratios were calculated to measure the strength of association. Multiple logistic regression analysis was applied to derive the final model. RESULTS: Anemia was detected in 80.3% of children, and 59.6% of children were undernourished as indicated by CIAF. The overall prevalence of acute morbidity was 59.9%. Children with mild anemia, moderate anemia and severe anemia had 1.52, 1.61 and 9.21 times higher risk of being morbid, respectively. Similarly, children with single, 2 and 3 anthropometric failures had 1.16, 1.29 and 2.27 times higher risk of being morbid, respectively. Out of 594 (60%) children with at least one of the acute morbidities, 520 (87.5%) sought health care, where majority (66.1%) received treatment from private clinics. The final model suggested that anemia and mother's poor educational status are predictors of childhood morbidity. CONCLUSIONS: Nutritional anemia and mother's poor educational status are the most important risk factors of acute childhood morbidity. There is need to revitalize existing health care delivery and child health programs in rural India with emphasis on immediate correction of nutritional anemia.

Evaluation of WHO haemoglobin colour scale & palmar pallor for screening of anaemia among children (6-35 months) in rural Wardha, India.

BACKGROUND & OBJECTIVE: Anaemia is a public health problem in India, particularly in women and children. Clinical diagnosis by health workers may be inaccurate. It is therefore important to evaluate simple methods for diagnosis of anaemia in rural set up with no or minimal laboratory facilities. We carried out this study to evaluate the performance of haemoglobin colour scale and palmar pallor against filter paper cyanmethaemoglobin method as screening methods for anaemia in children 6-35 months of age. METHODS: A total of 772 children between 6-35 months were studied from three primary health centres of Wardha district, central India, by house-to-house visit. The child was examined for presence of palmar pallor and haemoglobin estimated by haemoglobin colour scale (HCS) and filter paper cyanmethaemoglobin method independently by two persons. RESULTS: Haemoglobin colour scale had sensitivity of 89 per cent and specificity of 97 per cent in detecting anaemia in children. Pallor had sensitivity of 73 per cent and specificity of 98 per cent. The predictive values were 99 per cent and 69 per cent for positive and negative HCS result. Similarly, the predictive values were 99 and 48 per cent for positive and negative pallor result. Correct diagnosis of anaemia was 34 and 0.1 times common if HCS test result was positive (Hb < 110.0 g/l) and negative (Hb > 110.0 g/l) for anaemia. INTERPRETATION & CONCLUSION: HCS fulfills the requirement of field test for screening of anaemia in resource poor country. It also has acceptable precision and accuracy and hence can be used in national anaemia control programmes.