A pre-post study of a multi-country scale up of resuscitation training of facility birth attendants: Does Helping Babies Breathe training save lives?

Background: Whether facility-based implementation of Helping Babies Breathe (HBB) reduces neonatal mortality at a population level in low and middle income countries (LMIC) has not been studied. Therefore, we evaluated HBB implementation in this context where our study team has ongoing prospective outcome data on all pregnancies regardless of place of delivery. Methods: We compared outcomes of birth cohorts in three sites in India and Kenya pre-post implementation of a facility-based intervention, using a prospective, population-based registry in 52 geographic clusters. Our hypothesis was that HBB implementation would result in a 20 % decrease in the perinatal mortality rate (PMR) among births ≥1500 g. Results: We enrolled 70,704 births during two 12-month study periods. Births within each site did not differ pre-post intervention, except for an increased proportion of <2500 g newborns and deliveries by caesarean section in the post period. There were no significant differences in PMR among all registry births; however, a post-hoc analysis stratified by birthweight documented improvement in <2500 g mortality in Belgaum in both registry and in HBB-trained facility births. No improvement in <2500 g mortality measures was noted in Nagpur or Kenya and there was no improvement in normal birth weight survival. Conclusions: Rapid scale up of HBB training of facility birth attendants in three diverse sites in India and Kenya was not associated with consistent improvements in mortality among all neonates ≥1500 g; however, differential improvements in <2500 g survival in Belgaum suggest the need for careful implementation of HBB training with attention to the target population, data collection, and ongoing quality monitoring activities. Trial registration: The study was registered at ClinicalTrials.gov: NCT01681017. The detailed study methods published elsewhere [8, 10–12] are summarized below. This pre-post study was conducted in three research sites of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Global Network for Women’s and Children’s Health Research (GN). The sites included semi-urban and rural communities in Belgaum and Nagpur, India, and rural communities in western Kenya. The GN's Maternal and Newborn Health Registry (registry) was established in 2008. It is a prospective, population-based registry of all pregnancy and neonatal outcomes through 42 days postpartum in 52 clusters (defined geographic catchment areas) with 300–500 annual births. Inclusion criteria included facilities that provided delivery services 24 h per day/7 days per week and represented a significant proportion of the births in Belgaum (47 %), Nagpur (44 %), and western Kenya (38 %). Belgaum’s participating health facilities included 19 primary level (no caesarean [c]-section), 12 secondary (c-section staff on call), and 2 tertiary (c-section staff in hospital 24 h/day) facilities; Nagpur had 2 primary, 4 secondary, and 9 tertiary facilities; Kenya had 18 primary and 5 secondary facilities (Table 1). Demographic and clinical characteristics of all registry births ≥1500 g pre-post HBB intervention a Deliveries indicate number of mothers b Birth weight measured or estimated within 7 days of delivery (N = 516 excluded). Birth weight values > 5500 g are excluded (n = 8) c Primary facilities do not perform c-sections; secondary facilities have c-section staff on call; tertiary facilities have 24 h/7 days per week c-section staff available All facilities and Master Trainers received HBB training materials and equipment (Laerdal NeoNatalie® equipment and materials and clean delivery kits) based on delivery volume. The American Academy of Pediatrics HBB core staff identified best HBB training practices, assisted in developing two tiers of training workshops, and co-led the initial Master Trainer (MT) workshops. The initial single-country MT courses provided intense, hands-on training to provide at least one MT per facility in order to preserve the integrity of the intervention and expedite startup. The newly-trained MTs then conducted multiple facility-level BA team trainings with standard HBB knowledge and skills evaluation before and after the initial and refresher training courses approximately 6 months later, using the same interactive format with a maximum ratio of 6 BAs per MT. Staff turnover was addressed by providing HBB training to each new BA. The monitoring activities included direct supervision, team building and accountability measures to maintain standardized delivery room records; daily checks of equipment availability and cleanliness, daily “low dose/high frequency” [13] bag and mask ventilation practice; resuscitation debriefings and death audits; observation of deliveries or HBB skills (using a neonatal simulator if no deliveries were available) during regular and unannounced site visits; review of monthly monitoring reports and biweekly data review calls between the individual site HBB coordinators and the central core staff (RTI International and NICHD), followed by feedback to facility MTs and BAs. The pre phase was defined as the 12-month period preceding the completion of initial BA training; the post period was defined as the subsequent 12 months. Sites were also trained in basic essential newborn care [14]. The primary hypothesis was that implementation of the HBB package in facilities with substantial proportions of eligible registry newborns would decrease the PMR by 20 % among all registry births ≥1500 g in the 52 clusters. Secondary outcomes included the pre-post difference in the (1) fresh stillbirth rate (FSBR); (2) death by 1 day, including FSBs; and (3) 7-day neonatal mortality rate (NMR) among all live registry births and registry births in HBB-trained facilities. SBs were considered intrapartum or FSBs if they were not macerated (MSB). The PMR was estimated by dividing the sum of FSBs and live births dying within 7 days by all births, a modification of the common PMR definition to exclude MSBs that cannot be resuscitated. Day 1 mortality rate included FSB plus deaths by 24 h in the numerator and FSB and live births in the denominator; 7-day NMR included deaths of live births in the numerator and all live births in the denominator. Primary outcome and key secondary outcome data were collected by an independent registry staff. The research staff at each site collected additional data to evaluate the HBB training program and monitoring activities in the facilities. Consistent with the overall study goal outlined earlier, the study was powered to detect the overall public health impact of the intervention based on an assumption that the intervention would improve access and increase the number of facility births. We therefore estimated the power to detect the impact of implementation of HBB training in facilities to improve the mortality rates at the population (registry) level. Assuming a PMR of 25/1000 among newborns ≥1500 g, a standard deviation of 10 between clusters, and a correlation across the periods of 0.3 (based on historic registry data), the study had an estimated power of 82 % to detect a 20 % reduction in PMR among newborns ≥1500 g. While the study was not powered to detect an interaction effect between intervention and site or to detect differences in secondary mortality outcomes, the study had sufficient sample size to provide valuable information about these secondary outcomes, e.g., the effect of the intervention based on the subset of deliveries that occurred at the HBB trained health facilities. Under the original design assumptions about heterogeneity of risk across clusters and the correlation within clusters over time, the sample sizes within the HBB-facility deliveries provided 80 % power to detect a 30 % risk reduction and a 90 % power to detect a 35 % reduction in mortality risk in these facilities. Absent significant differences in the primary outcome or this important secondary outcome, the analyses were constructed to provide point and interval estimates of the magnitude of both public health and in-facility benefit obtained from the intervention. The primary outcome was tested using a linear mixed model that incorporated a random cluster-effect term to account for correlation within clusters across time and a fixed binary-time effect (pre-post HBB) that represented the treatment effect. The dependent variable was the cluster PMR aggregated separately across the pre and post periods. Secondary mortality outcomes were analyzed using linear mixed models, incorporating both random-cluster effects and fixed effects for pre and post periods. The interaction between site and treatment was tested for the primary and secondary outcomes. Secondary parameter estimates of combinations of time and period evaluated whether the treatment effect changed over the course of the study.