Burden of pain in back and extremities in rural population: A community-based estimation of 12-month prevalence, distribution and duration of pain in rural Gadchiroli, India.

BACKGROUND: Population based estimates of the burden of pain in back and extremities (PBE) are lacking from rural India. We estimated this burden, measured as a) 12-month prevalence, b) site specific prevalence c) total number of painful sites per adult, d) severity of pain and e) duration of pain in the rural adult population in Gadchiroli, India, over a period of 12 months. METHODS: This population-based, cross-sectional study was conducted in two villages randomly selected from a cluster of 7 eligible villages in Gadchiroli district of India. All adults ≥20 years in these villages were surveyed by the trained community health workers in January 2010 by making household visits. The data were collected using a structured, pretested questionnaire on the history of pain in back and extremities (PBE) at various anatomical sites and its features during the previous 12 months. RESULTS: Out of 2535 eligible adults in two villages, 2259 (89%) were interviewed, of which 1876 (83%) had an episode of PBE in the preceding 12 months. The period prevalence of pain was 76% in back (including lower back, thoracic and neck) and 71% in the extremities. Highest site specific prevalence was at lower back (70%), knee (46%), neck (44%), leg/calf (39%) and mid-back (39%). The mean number of painful sites per adult was 4.57 (standard deviation (SD) = 4.17). The prevalence of severe pain was 15%. The mean number of painful days due to PBE was 166 days. Female gender (odds ratio (OR) = 2.8, 95% confidence interval (CI) = 2.1-3.6), farming/labour occupation (OR = 1.8, 95% CI = 1.4-2.4), increasing age (more than 60 years OR = 6.3, 95% CI = 3.3-11.9) were significantly associated with the risk of PBE. CONCLUSION: Nearly five out of six adults in rural Gadchiroli suffered from pain in back or extremities during the preceding 12 months. Pain was at multiple sites and was present on a mean 166 days in the year. Female gender, farming / manual labor as occupation and increasing age were the key risk factors identified. The pain in back and extremities emerges as a public health priority in rural communities.

Activity limitation and disability due to pain in back and extremities in rural population: A community-based study during a period of twelve months in rural Gadchiroli, India.

BACKGROUND: Population based estimates of the extent of the activity limitation due to back pain and disability due to musculoskeletal pains are lacking from rural India. We estimated this burden as a) extent of activity limitation due to back pain, b) disability due to musculoskeletal pains, c) grading of the limitation of each activity due to back and musculoskeletal pain in the rural adult population in Gadchiroli, India. METHODS: This population-based, cross-sectional study was conducted in two villages randomly selected from a cluster of 7 eligible villages in Gadchiroli district of India. All adults ≥20 years in these villages were surveyed by the trained community health workers in January 2010. Disability due to back pain was evaluated using newly developed questionnaire for women and men which assessed limitations in the gender-specific daily household and occupational activities in a rural area. Disability due to pain in extremities was assessed using the Health Assessment Questionnaire (HAQ). RESULTS: The total population of the two villages was 3735 out of which 2535 (67.9%) were adults ≥20 years of age and were eligible to participate in the study. Of these, 2259 (89%) were interviewed and 1247 participants (55%) had any pain on the day of the survey. Activity limitation questionnaire was filled for 716 (91.4%) out of 783 patients with back pain. HAQ scale was filled for 524 (85.2%) out of 615 patients with pain in extremities. Among men with back pain, respectively 11%, 19%, 60% and 11% had no, mild, moderate to severe difficulty or were completely unable to perform agrarian work, while among women, respectively 6%, 20%, 69% and 4% had no, mild, moderate to severe difficulty or were completely unable to perform household activities. Based on the HAQ score, respectively 1%, 67%, 18% and 14% of the participants had no, mild, moderate to severe disability or were completely unable to perform the activities. CONCLUSIONS: This community-based study in rural Gadchiroli demonstrates significant mild to moderate disability and activity limitation, due to pain in back and extremities in a population involved in hard manual work, especially agricultural and underlines the need to address the problem through appropriate interventions. The study also employs for the first time an indigenously developed questionnaire to identify activity limitation due to back pain, and demonstrates the method as well as the questionnaire.

Epidemiology of pain in back and extremities in rural population: A community-based estimation of age- and sex-specific prevalence, distribution, duration and intensity of pain, number of painful sites and seasonality of pain during twelve months in rural Gadchiroli, India.

BACKGROUND: Population-based estimates of the burden of pain in back and extremities (PBE) by sex, age, intensity, seasonality and site are lacking from rural India. METHODS: Two villages were randomly selected from a cluster of 39 villages in Gadchiroli district in India. All residents'≥20 years of age were surveyed in January 2010 by trained surveyors by making household visits. Information on PBE in the 12 months prior to survey was obtained using a structured, pretested questionnaire. RESULTS: The 12-month period prevalence of PBE was 75% (95% confidence interval CI = 72.54-77.73) in men and 91% (95% CI = 88.66-92.13) in women. The prevalence of PBE in the participants >50 years was 94% while that in the age group 20 to 50 years was 79% (P < 0.05). The site with the highest prevalence of pain was low back (women 80%, men 59%). The mean number of painful sites per person was 5.42 (95% CI = 5.17-5.67) in women, 3.68 (95% CI = 3.45-3.90) in men, 3.89 (95% CI = 3.71-4.07) in participants aged 20 to 50 years and 6.48 (95% CI = 6.11-6.85) in those >50 years. Among participants across the age and sex groups, the prevalence of mild pain was higher than severe pain at all the anatomical sites. Among various seasons, the highest prevalence of pain was in the rainy season (14%). CONCLUSION: The prevalence and the number of painful sites were higher among women and in those >50 years of age. The public health interventions for PBE need to focus on these two high risk groups.

Clinical patterns and their prevalence among adult population with back pain: A community-based cross-sectional study in rural Gadchiroli, India.

BACKGROUND: Evaluating clinical patterns and their prevalence of back pain, a common problem in rural areas, can help develop treatment strategies to address this leading cause of disability. METHODS: We conducted a population-based study in rural Gadchiroli, India. In this, two-phase study, trained surveyors conducted a door to door survey (Phase 1) to identify individuals with pain in the back and extremities in two villages randomly selected using pre-defined criteria. Those with pain were evaluated by a team of spine surgeons and rheumatologists to diagnose clinical conditions among these patients (Phase 2). RESULTS: Of the 2535 eligible adults, 2259 (89%) were screened, 1247 (55%) reported pain in back and limb and were referred to the specialist clinic. Out of the 906 (73%) participants who attended the clinics, 783 (89%) had back/neck pain. The point prevalence of back/neck pain among adults was 49% (95% confidence interval (CI) = 49%-51%), non-specific low back pain 45% (95% CI = 43.4%-47.5%); non-specific neck pain 21% (95% CI = 18.9-22.4), radiculopathy 12 (95% CI = 10.4-13.1), myelopathy 0.4 (95% CI = 0.1-0.7) and other serious spinal disorders 0.2 (95% CI 0.048-0.45). The prevalence of non-specific back/neck pain and radiculopathy was higher among females. CONCLUSIONS: Non-specific back and neck pain are the commonest diagnoses among those with pain in the back and extremities, followed by radiculopathy. Serious disorders are rare. Given the high prevalence of non-specific back and neck pain, community health workers and physicians working in rural areas need to be trained systematically to manage these conditions.

Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial in India.

BACKGROUND: Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates. METHODS: This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters. FINDINGS: A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm. INTERPRETATION: Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births. TRIAL REGISTRATION NUMBER: The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).

Simple clinical criteria to identify sepsis or pneumonia in neonates in the community needing treatment or referral.

BACKGROUND: Sepsis, meningitis and pneumonia annually kill 1.1 million neonates in developing countries; most deaths occur at home. OBJECTIVES: To develop simple clinical criteria, enabling health workers in communities to identify neonates with potentially fatal sepsis; and to identify the danger signs alerting mothers to seek care. METHODS: In a field trial in 39 villages in Gadchiroli, India, trained health workers visited all neonates at home 8 times during the first 28 days of life, recording signs and outcome without interventions during 1995-1996 and with home-based management of sick neonates during 1996-1999. An independent neonatologist assigned the cause of death. We use the term "sepsis" to include sepsis, meningitis and pneumonia. We evaluated 31 signs as predictors of 43 sepsis deaths among 3567 neonates. We also evaluated mothers' observations as the danger signs to seek care. RESULTS: Simultaneous presence of any 2 of 7 signs (reduced or stopped sucking; weak or no cry; limbs becoming limp; vomiting or abdominal distension; baby cold to touch; severe chest indrawing; umbilical infection) predicted sepsis death with sensitivity 100%, specificity 92%, positive predictive value 27.2% and negative predictive value 100% in the nonintervention period. The criteria identified 10.6% of the neonates in the community as suspected sepsis, at a mean of 5.4 days before death. The criteria remained valid in the postintervention period. Any 1 of the 5 maternally observed danger signs (reduced sucking, drowsy or unconscious, baby cold to touch, fast breathing and chest indrawing) gave 100% sensitivity and identified 23.9% neonates for seeking care. CONCLUSION: These criteria identify neonates in the community who are at risk for dying of infection with excellent sensitivity, specificity and negative predictive value but a moderate positive predictive value. They can be used by health workers to select sick neonates for treatment or referral. One potentially fatal case would be treated per 4 presumptive cases treated.

Background of the field trial of home-based neonatal care in Gadchiroli, India.

The field trial of home-based neonatal care was conducted in Gadchiroli, India during 1993 to 1998. Owing to its new approach and the success in reducing newborn mortality in a rural area, it has attracted considerable attention. In this article, we describe the background of the trial -- the situation in 1990, why the problems of neonatal mortality and neonatal infection were selected for research, the area -- Gadchiroli district -- where the study was conducted, and the background work and philosophy of the organization, SEARCH, which conducted the study. This history and background will help readers understand the origins and the context of the field trial and the subsequent research papers in this supplement. We also hope that sharing this will be of use to other researchers and program managers working with communities in developing countries.

How to identify neonates at risk of death in rural India: clinical criteria for the risk approach.

OBJECTIVE: Majority of neonates in developing countries are born at home and most neonatal deaths occur without receiving medical care. This retrospective analysis was undertaken to develop simple clinical criteria for use in rural community to identify neonates at risk of death. STUDY DESIGN: By analyzing the observational data on two cohorts of neonates in 39 villages in different years of the Gadchiroli field trial, we selected a minimum set of clinical features. We evaluated this set for its sensitivity, specificity and predictive value to detect eventual neonatal death, the primary study outcome. RESULTS: The cohorts included 763 neonates with 40 deaths in 1995 to 1996, a year with minimum interventions, and 1598 neonates with 38 deaths in 1996 to 1998, the years of intensive interventions. On the day of birth, presence of any one of the three: (1) birth weight <2000 g, (2) preterm birth or (3) baby not taking feeds; or, during the rest of neonatal life, mother's report of reduced or stopped sucking by baby, were identified as the predictors of neonatal deaths. The combined set gave a sensitivity of 95%, specificity, 77.3%; predictive value, 18.8%; and the yield, 26.5% in 1995 to 1996 and, respectively, 86.8, 78, 8.8, and 23.5% in 1996 to 1998. The mean lead time gained was 3.4 to 6.6 days. CONCLUSION: Presence of any one of the four predictors will identify with high sensitivity and moderate specificity nearly a quarter of the neonates in rural community as high risk, 3.4 to 6.6 days in advance, for intensive attention at home or referral.

Home-based neonatal care: summary and applications of the field trial in rural Gadchiroli, India (1993 to 2003).

High levels of neonatal mortality and lack of access to neonatal health care are widespread problems in developing countries. A field trial of home-based neonatal care (HBNC) was conducted in rural Gadchiroli, India to develop and test the feasibility of a low-cost approach of delivering primary neonatal care by using the human potential available in villages, and to evaluate its effect on neonatal mortality. In the first half of this article we summarize various aspects of the field trial, presented in the previous 11 articles in this issue of the journal supplement. The background, objectives, study design and interventions in the field trial and the results over 10 years (1993 to 2003) are presented. Based on these results, the hypotheses are tested and conclusions presented. In the second half, we discuss the next questions: can it be replicated? Can this intervention become a part of primary health-care services? What is the cost and the cost-effectiveness of HBNC? The limitations of the approach, the settings where HBNC might be relevant and the management pre-requisites for its scaling up are also discussed. The need to develop an integrated approach is emphasized. A case for newborn care in the community is made for achieving equity in health care.

Methods and the baseline situation in the field trial of home-based neonatal care in Gadchiroli, India.

In this paper, we describe the planning of the field trial and the methods used for collecting baseline health and ethnographic data in a rural field study site. We describe the study hypotheses, specific objectives, study design, sample size estimates, selection of study area, community consent, the organization of study teams, review mechanism, financial support and baseline data collection. Baseline population characteristics and vital statistics are presented. The qualitative information on traditional beliefs and practices prevalent in the study area revealed that parents felt powerless about newborn health and sickness. There was an enormous unmet need to reach the home-delivered neonates and their care-givers with the correct knowledge and health-care practices.

The incidence of morbidities in a cohort of neonates in rural Gadchiroli, India: seasonal and temporal variation and a hypothesis about prevention.

BACKGROUND: The incidence of morbidities among home-cared neonates in rural areas has not been studied. OBJECTIVES: To estimate the incidence of various neonatal morbidities and the associated risk of death in home-cared neonates in rural setting. To estimate the variation in the incidence of neonatal morbidities by season and by day of life. To identify the scope for prevention of morbidities and suggest a hypothesis. STUDY DESIGN: A prospective observational study nested in the first year of the field trial in rural Gadchiroli, India. Trained village health workers in 39 villages observed neonates at the time of birth and in subsequent eight home visits up to 28 days. We diagnosed 20 neonatal morbidities by using clinical definitions. The data were analyzed for the incidence, case fatality, and relative risk of death and for the seasonal and day-wise variation in the incidence of morbidities. RESULTS: We observed total 763 neonates in 1 year. The incidence of morbidities was a mean of 2.2 morbidities per neonate. The case fatality in 13 morbidities was >10%. Only 2.6% neonates were seen or treated by a physician, and 0.4% were hospitalized. Hypothermia, fever, upper respiratory symptoms, umbilical and skin infections, and conjunctivitis showed statistically significant seasonal variation. Although the morbidities were concentrated in the first week of life, new cases continued to appear throughout the neonatal period. Various morbidities showed different distribution of incidence during 1 to 28 days. CONCLUSIONS: A large burden of disease occurs in rural home-cared neonates, and many morbidities are associated with high case fatality. Some morbidities show strong seasonal and day-wise variation in incidence, indicating poor care at home. We hypothesize that changes in practices and better home-based care will prevent the seasonal and temporal increase in morbidities. Some morbidities may not be preventable and will need early detection and treatment. Therefore, frequent home visits by a health worker are necessary to identify sick neonates.

Why do neonates die in rural Gadchiroli, India? (Part I): primary causes of death assigned by neonatologist based on prospectively observed records.

OBJECTIVE: To determine the primary causes of death in home-cared rural neonates by using prospectively kept health records of neonates and a neonatologist's clinical judgment. STUDY DESIGN: In the first year (1995 to 1996) of the field trial in Gadchiroli, India, trained village health workers observed neonates in 39 villages by attending home deliveries and making eight home visits during days 0 to 28. The recorded data were validated in the field by a physician. An independent neonatologist assigned the most probable single primary cause of death based on these recorded data. FINDINGS: A total of 763 neonates were observed, of whom 40 died (NMR 52.4/1000). The primary causes of death were sepsis/pneumonia 21 (52.5%), asphyxia 8 (20%), prematurity <32 weeks 6 (15%), hypothermia 1 (2.5%), and other/not known 4 (10%). Most of the prematurity or asphyxia deaths occurred during the first 3 days of life. All 21 sepsis/pneumonia deaths occurred during days 4 to 28. A similar picture existed in England before the antibiotic era. CONCLUSION: Sepsis/pneumonia is the primary cause in half the deaths in rural neonates cared for at home in Gadchiroli, followed by asphyxia and prematurity. Infections cause a larger proportion of deaths in neonates in the community compared to the reported proportion in hospital-based studies.

Why do neonates die in rural Gadchiroli, India? (Part II): estimating population attributable risks and contribution of multiple morbidities for identifying a strategy to prevent deaths.

OBJECTIVES: The understanding about why neonates die in rural areas in developing countries is limited. In the first year (1995 to 1996) of the field trial of home-based neonatal care in rural Gadchiroli, India, we prospectively observed a cohort of neonates in 39 villages. In Part I of this article, we presented the primary causes of death. The data were further analyzed: To estimate the population attributable risk (PAR) of death for the main causes of neonatal mortality. To evaluate the effect of a multiplicity of morbidities and to identify which morbidity combinations cause neonatal deaths. To develop a hypothesis about how best to reduce neonatal mortality. STUDY DESIGN: We analyzed the observational data by logistic regression to estimate the PAR of death for six major morbidities. The effect of the number of morbidities per neonate on case fatality (CF) was estimated. Then we identified the main combinations of morbidities as the component causes leading to death. We estimated the excess deaths attributable to sepsis. RESULTS: This cohort included 763 neonates among whom 40 neonatal deaths occurred. Six major morbidities were associated with the following proportion of deaths: preterm, 62.5%; sepsis, 60%; intrauterine growth restriction (IUGR), 27.5%; asphyxia, 25%; hypothermia, 22.5%, and feeding problems, 15%. The estimated PARs were: preterm, 0.74; IUGR, 0.55; sepsis, 0.55; asphyxia, 0.35; hypothermia, 0.08, and feeding problems, 0.04. The CF associated with the number of morbidities per neonate was: with no morbidity, 0.3%; one morbidity, 2.1%; two morbidities, 15.3%; three or more morbidities, 41.4% (p<0.001). In all, 82.5% of all deaths occurred in neonates with two or more morbidities. The proportion of total deaths associated with only preterm was 7.5%, and with only IUGR was 2.5%; however, with the main morbidity combinations it was preterm+sepsis, 35%; IUGR+sepsis, 22.5%; preterm+asphyxia, 20%; preterm+hypothermia, 15%; and preterm+feeding problem, 12.5%. The % CF with low birth weight (LBW) <2500 g alone was 5.2% and with infection alone was 1.9%, but with LBW+infection it was 31.9%. The estimated excess deaths caused by sepsis over and above LBW was 44% of the total deaths. CONCLUSIONS: Preterm and IUGR are ubiquitous components, but usually not sufficient to cause death. Most deaths occur due to a combination of preterm or IUGR with other comorbidities. If preterm birth or IUGR cannot be prevented, the strategy should be to ensure neonatal survival by addressing comorbidities, that is, infections, asphyxia, hypothermia, and feeding problems in that order of priority. We hypothesize that the prevention and/or management of neonatal infections will reduce neonatal mortality by 40 to 50%.

Reduced incidence of neonatal morbidities: effect of home-based neonatal care in rural Gadchiroli, India.

OBJECTIVE: We found a high burden of morbidities in a cohort of neonates observed in rural Gadchiroli, India. We hypothesised that interventions would reduce the incidence of neonatal morbidities, including the seasonal increase observed in many of them. This article reports the effect of home-based neonatal care on neonatal morbidities in the intervention arm of the field trial by comparing the early vs late periods, and the possible explanation for this effect. METHODS: During 3 years (1995 to 1998), trained village-health-workers (VHWs) in 39 villages prospectively collected data by making home visits during pregnancy, home-delivery and during neonatal period. We estimated the incidence and burden of neonatal morbidities over the 3 years from these data. In the first year, the VHWs made home visits only to observe. From the second year, they assisted mothers in neonatal care and managed the sick neonates at home. Health education of mothers and family members, individually and in group, was added in the third year. We measured the coverage of interventions over the 3 years and evaluated maternal knowledge and practices on 21 indicators in the third year. The effect on 17 morbidities was estimated by comparing the incidence in the first year with the third year. RESULTS: The VHWs observed 763 neonates in the first year, 685 in the second and 913 in the third year. The change in the percent incidence of morbidities was (i) infections, from 61.6 to 27.5 (-55%; p<0.001), (ii) care-related morbidities (asphyxia, hypothermia, feeding problems) from 48.2 to 26.3 (-45%; p<0.001); (iii) low birth weight from 41.9 to 35.2 (-16%; p<0.05); (iv) preterm birth and congenital anomalies remained unchanged. The mean number of morbidities/100 neonates in the 3 years was 228, 170 and 115 (a reduction of 49.6%; p<0.001). These reductions accompanied an increasing percent score of interventions during 3 years: 37.9, 58.4 and 81.3, thus showing a dose-response relationship. In the third year, the proportion of correct maternal knowledge was 78.7% and behaviours was 69.7%. The significant seasonal increase earlier observed in the incidence of five morbidities reduced in the third year. CONCLUSION: The home-based care and health education reduced the incidence and burden of neonatal morbidities by nearly half. The effect was broad, but was especially pronounced on infections, care-related morbidities and on the seasonal increase in morbidities.

Low birth weight and preterm neonates: can they be managed at home by mother and a trained village health worker?

OBJECTIVE: Observations on a cohort of neonates in the preintervention year of the field trial of home-based neonatal care (HBNC) in rural Gadchiroli, India, showed that preterm birth and low birth weight (LBW), <2500 g, constituted the most important risk factors. Owing to a limited access to hospital care, most neonates were managed at home in the subsequent intervention years. The objective of this paper is to evaluate the feasibility and effectiveness of managing LBW and preterm neonates in home setting. DESIGN: We retrospectively analyzed data from the intervention arm (39 villages) in the HBNC trial. Feasibility was assessed by coverage and by quality (19 indicators) of care. Effectiveness was evaluated by change in case fatality (CF) and in the incidence of comorbidities in LBW or preterm neonates by comparing the preintervention year (1995 to 1996) with the intervention years (1996 to 2003). RESULTS: During 1996 to 2003, total 5919 live births occurred in the intervention villages, out of whom 5510 (93%) received HBNC. These included 2015 LBW neonates and 533 preterm neonates, out of whom 97% received only home-based care. The coverage and quality of interventions assessed on 19 indicators was 80.5%. The CF in LBW neonates declined by 58% (from 11.3 to 4.7%, p<0.001), and in preterm neonates, by 69.5% (from 33.3 to 10.2%, p<0.0001). Incidence of the major comorbidities, viz., sepsis, asphyxia, hypothermia and feeding problems, declined significantly. Preterm-LBW neonates without sepsis (270) received only supportive care -- CF in them decreased from 28.2 to 11.5% (p<0.01), and those with sepsis (53) received supportive care and antibiotics -- CF in them decreased from 61 to 13.2% (p<0.005). Supportive care contributed 75% and treatment with antibiotics 25% in the total averted deaths in preterm-LBW neonates. The intrauterine growth restriction (IUGR)-LBW neonates without sepsis (1409) received only supportive care -- the CF was unchanged, and 181 with sepsis received supportive care and antibiotics -- the CF decreased from 18.4 to 8.8% (p<0.05). Treatment with antibiotics explained entire reduction in mortality in IUGR neonates. In total, 55 deaths in LBW neonates were averted by supportive care and 35 by the treatment with antibiotics. CONCLUSIONS: Home-based management of LBW and the preterm neonates is feasible and effective. It remarkably improved survival by preventing comorbidities, by supportive care, and by treating infections.

Management of birth asphyxia in home deliveries in rural Gadchiroli: the effect of two types of birth attendants and of resuscitating with mouth-to-mouth, tube-mask or bag-mask.

OBJECTIVES: To evaluate the effect of home-based neonatal care on birth asphyxia and to compare the effectiveness of two types of workers and three methods of resuscitation in home delivery. STUDY DESIGN: In a field trial of home-based neonatal care in rural Gadchiroli, India, birth asphyxia in home deliveries was managed differently during different phases. Trained traditional birth attendants (TBA) used mouth-to-mouth resuscitation in the baseline years (1993 to 1995). Additional village health workers (VHWs) only observed in 1995 to 1996. In the intervention years (1996 to 2003), they used tube-mask (1996 to 1999) and bag-mask (1999 to 2003). The incidence, case fatality (CF) and asphyxia-specific mortality rate (ASMR) during different phases were compared. RESULTS: During the intervention years, 5033 home deliveries occurred. VHWs were present during 84% home deliveries. The incidence of mild birth asphyxia decreased by 60%, from 14% in the observation year (1995 to 1996) to 6% in the intervention years (p<0.0001). The incidence of severe asphyxia did not change significantly, but the CF in neonates with severe asphyxia decreased by 47.5%, from 39 to 20% (p<0.07) and ASMR by 65%, from 11 to 4% (p<0.02). Mouth-to-mouth resuscitation reduced the ASMR by 12%, tube-mask further reduced the CF by 27% and the ASMR by 67%. The bag-mask showed an additional decrease in CF of 39% and in the fresh stillbirth rate of 33% in comparison to tube-mask (not significant). The cost of bag and mask was US dollars 13 per averted death. Oxytocic injection administered by unqualified doctors showed an odds ratio of three for the occurrence of severe asphyxia or fresh stillbirth. CONCLUSIONS: Home-based interventions delivered by a team of TBA and a semiskilled VHW reduced the asphyxia-related neonatal mortality by 65% compared to only TBA. The bag-mask appears to be superior to tube-mask or mouth-to-mouth resuscitation, with an estimated equipment cost of US dollars 13 per death averted.

Neonatal and infant mortality in the ten years (1993 to 2003) of the Gadchiroli field trial: effect of home-based neonatal care.

OBJECTIVES: To evaluate the effect on neonatal and infant mortality during 10 years (1993 to 2003) in the field trial of home-based neonatal care (HBNC) in Gadchiroli. To estimate the contribution of the individual components in the intervention package on the observed effect. STUDY DESIGN: The field trial of HBNC in Gadchiroli, India, has completed the baseline phase (1993 to 1995), observational phase (1995 to 1996) and the 7 years of intervention (1996 to 2003). We measured the stillbirth rate (SBR), neonatal mortality rate (NMR), perinatal mortality rate (PMR), postneonatal mortality rate (PNMR) and the infant mortality rate (IMR) in the intervention area and the control area. The effect of HBNC on all these rates was estimated by comparing the change from baseline (1993 to 1995) to the last 2 years of intervention (2001 to 2003) in the intervention area vs in the control area. For other estimates, we made a before-after comparison of the rates in the intervention arm in the observation year (1995 to 1996) vs intervention years (1996 to 2003). We evaluated the effect on the cause-specific NMRs. By using the changes in the incidence and case fatality (CF) of the four main morbidities, we estimated the contribution of primary prevention and of the management of sick neonates. The proportion of deaths averted by different components of HBNC was estimated. RESULTS: The baseline population in 39 intervention villages was 39,312 and in 47 control villages it was 42,617, and the population characteristics and vital rates were similar. The total number of live births in 10 years (1993 to 2003) were 8811 and 9990, respectively. The NMR in the control area showed an increase from 58 in 1993 to 1995 to 64 in 2001 to 2003. The NMR in the intervention area declined from 62 to 25; the reduction in comparison to the control area was by 44 points (70%, 95% CI 59 to 81%). Early NMR decreased by 24 points (64%) and late NMR by 20 points (80%). The SBR decreased by 16 points (49%) and the PMR by 38 points (56%). The PNMR did not change, and the IMR decreased by 43 points (57%, 95% CI 46 to 68%). All reductions were highly significant (p<0.001) except for SBR it was <0.05. The cause-specific NMR (1995 to 1996 vs 2001 to 2003) for sepsis decreased by 90%, for asphyxia by 53% and for prematurity by 38%. The total reduction in neonatal mortality during intervention (1996 to 2003) was ascribed to sepsis management, 36%; supportive care of low birth weight (LBW) neonates, 34%; asphyxia management, 19%; primary prevention, 7% and management of other illnesses or unexplained, 4%. CONCLUSIONS: The HBNC package in the Gadchiroli field trial reduced the neonatal and perinatal mortality by large margins, and the gains were sustained at the end of the 7 years of intervention and were carried forward as improved survival through the first year of life. Most of the reduction in mortality was ascribed to sickness management, that is, management of sepsis, supportive care of LBW neonates and management of asphyxia, in that order, and a small portion to primary prevention.

Is home-based diagnosis and treatment of neonatal sepsis feasible and effective? Seven years of intervention in the Gadchiroli field trial (1996 to 2003).

OBJECTIVES: To further evaluate our earlier findings on the feasibility and effectiveness of home-based management of neonatal sepsis by analysing 7 years data (1996 to 2003) from the field trial in Gadchiroli, India. STUDY DESIGN: Neonates in 39 villages were monitored by trained village health workers (VHWs) from 1995 onwards. In 1996, we trained VHWs to diagnose sepsis by using a clinical algorithm and provide domiciliary treatment using intramuscular gentamicin and oral co-trimoxazole. Health records for all neonates were kept by the VHWs, checked by field supervisors, and computerized. Live births and neonatal deaths were recorded by an independent vital statistics collection system. We evaluated the feasibility and effectiveness of this approach. RESULTS: During September 1996 to March 2003, VHWs monitored 93% of all neonates in 39 villages (N=5268). As compared to 552 cases of sepsis diagnosed by computer algorithm, VHWs correctly diagnosed 492 cases (89%). Parents agreed to home-based treatment for the majority of infants (448, 91%), refused treatment in 31 (6.4%) cases, and hospitalized 13 infants (2.6%). VHWs treated 470 neonates with antibiotics, that is, 8.9% of all neonates in community. Of 552 cases diagnosed by computer, VHWs correctly treated 448 (81.2%) and gave unnecessary treatment to 22/470 (4.7%) of treated neonates. The case fatality (CF) was 6.9% in treated cases vs 22% in untreated or 16.6% in the pre-intervention period (p<0.001). Home-based treatment resulted in 67.2% reduction in %CF among preterm and a 72% reduction among LBW neonates. CONCLUSIONS: Home-based management of neonates with suspected sepsis is acceptable to most parents, safe, and effective in reducing sepsis case fatality by nearly 60%. With proper selection, training, and supervision of health workers, this method may be applicable in areas in developing countries where access to hospital care is limited.