Home-based management of neonatal sepsis: 23 years of sustained implementation and effectiveness in rural Gadchiroli, India, 1996-2019.

INTRODUCTION: Although hospitalisation remains the preferred management for neonatal sepsis, it is often not possible in resource-limited settings. The Home-Based Newborn Care (HBNC) study in Gadchiroli, India (1995-1998) was the first trial to demonstrate that neonatal sepsis can be managed in the community. HBNC continues to operate in Gadchiroli. In 2015, WHO recommended community-based management of neonatal sepsis when hospitalisation is not feasible but called for implementation research. We studied the implementation and effectiveness of home-based management of neonatal sepsis over 23 years in Gadchiroli. METHODS: In this cohort study (1996-2019), community health workers (CHWs) visited neonates at home in 39 villages in Gadchiroli, India. CHWs screened, diagnosed sepsis and offered home-based antibiotic treatment if hospitalisation was refused. We evaluated the implementation outcomes of coverage, diagnostic fidelity and adoption. We assessed the association between treatment type and odds of neonatal death using mixed effects logistic regression. Time trends were analysed using the Mann-Kendall test. RESULTS: CHWs screened 93.8% (17 700/18 874) of neonates (coverage) and correctly diagnosed 89% (1051/1177) of sepsis episodes (diagnostic fidelity). Home-based management was preferred by 88.4% (929/1051) of parents (adoption), with 5.6 percent of total neonates receiving antibioties at home. Compared with neonates treated at home, the adjusted odds of death was 5.27 (95% CI 1.91 to 14.58) times higher when parents refused all treatment, 2.17 (95% CI 1.07 to 4.41) times higher when CHWs missed the diagnosis and 5.45 (95% CI 2.74 to 10.87) times higher when parents accepted hospital referral. Implementation outcomes remained consistent over 23 years (coverage p=0.57; fidelity p=0.57; adoption p=0.26; mortality p=0.71). The rate of facility births increased (p<0.01) and the sepsis incidence decreased (p<0.05) over 23 years. CONCLUSION: Implementation of home-based management of neonatal sepsis was sustainable and effective over 23 years. During this period, the need for home-based management in Gadchiroli is declining. Home-based management is advised where sepsis remains a major cause of neonatal mortality and hospital access is limited.

Decline in the Incidence of Neonatal Sepsis in Rural Gadchiroli, India During the Twenty-one Years (1998-2019) Following the Home-based Neonatal Care Field-trial.

BACKGROUND: Sepsis is a leading cause of neonatal mortality globally. The home-based neonatal care (HBNC) field trial (1995-1998) in rural Gadchiroli demonstrated a reduction in the incidence of neonatal sepsis. The current study examines the trend of neonatal sepsis during the twenty-one years (1998-2019) following the trial's completion. METHODS: We conducted a retrospective cohort study based on the HBNC program data in rural Gadchiroli, India, from April 1998 to March 2019. All live-born neonates who spent all or part of the neonatal period in the 39 study villages and received HBNC were eligible for inclusion. Sepsis was diagnosed during regular home visits by trained village health workers if pre-specified clinical criteria were present. Sepsis incidence was computed for seven 3-year periods. Trend analyses were conducted using the Mann-Kendall test. RESULTS: Of the total 17,289 live births, 16,339 (94.5%) home visited were included. In this cohort, 1069 (65 per 1000 live births) neonates were diagnosed with sepsis. The incidence of neonatal sepsis declined from 111 per 1000 live births in 1998 to 2001 to 19 per 1000 live births in 2016 to 2019, an 82.9% decrease (P < 0.0001), mean 4% decrease per year. The incidence of neonatal sepsis declined for early-onset sepsis (P < 0.0001), late-onset sepsis (P < 0.0001), home births (P = 0.006), facility births (P < 0.0001), preterm neonates (P < 0.0001) and full-term neonates (P < 0.0001). CONCLUSIONS: The incidence of neonatal sepsis in rural Gadchiroli has continued to decline during the past twenty-one years. We hypothesize that the decline is due to the ongoing practice of HBNC, improved socioeconomic conditions, and new governmental health policies.

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.

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.

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.

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.

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.

Maternal morbidity during labour and the puerperium in rural homes and the need for medical attention: A prospective observational study in Gadchiroli, India.

OBJECTIVES: To estimate the incidence of maternal morbidity during labour and the puerperium in rural homes, the association with perinatal outcome and the proportion of women needing medical attention. DESIGN: Prospective observational study nested in a neonatal care trial. SETTING: Thirty-nine villages in the Gadchiroli district, Maharashtra, India. SAMPLE: Seven hundred and seventy-two women recruited over a one year period (1995-1996) and followed up from the seventh month in pregnancy to 28 days postpartum (up to 10 visits in total). METHODS: Observations at home by trained village health workers, validated by a physician. Diagnosis of morbidities by computer program. MAIN OUTCOMES: Direct obstetric complications during labour and the puerperium, breast problems, psychiatric problems and need for medical attention. RESULTS: The incidence of maternal morbidity was 52.6%, 17.7% during labour and 42.9% during puerperium. The most common intrapartum morbidities were prolonged labour (10.1%), prolonged rupture of membranes (5.7%), abnormal presentation (4.0%) and primary postpartum haemorrhage (3.2%). The postpartum morbidities included breast problems (18.4%), secondary postpartum haemorrhage (15.2%), puerperal genital infections (10.2%) and insomnia (7.4%). Abnormal presentation and some puerperal complications (infection, fits, psychosis and breast problems) were significantly associated with adverse perinatal outcomes, but prolonged labour was not. A third of the mothers were in need of medical attention: 15.3% required emergency obstetric care and 24.0% required non-emergency medical attention. CONCLUSIONS: Nearly 15% of women who deliver in rural homes potentially need emergency obstetric care. Frequent (43%) postpartum morbidity, and its association with adverse perinatal outcome, suggests the need for home-based postpartum care in developing countries for both mother and baby.