Comparison of perinatal outcomes in facilities before and after Global Network’s Helping Babies Breathe Implementation Study in Nagpur, India

Neonatal deaths now account for around 46% of the under-5-years-old deaths and must be addressed to accelerate progress towards Sustainable Development Goal 3 (SDG3) [1‐4], because one of the targets under SDG3 is to reduce the neonatal mortality to 12 per 1000 livebirths by 2030 [5]. While neonatal deaths have fallen from 5 to 2.5 million from 1990 to 2017, the annual rate of reduction in neonatal mortality over this period (2.6% per year) is much lower than that for children aged 1–59 months (3.7%) [1]. Among live-born babies, the risk of death is greatest on the first day of life–about 1 million deaths a year and 36% of all neonatal deaths [2]. Many of these deaths are caused by birth asphyxia or failure to establish breathing at birth. Excluded from these deaths are the estimated 1.3 million intrapartum or “fresh” stillbirths [6] who are not breathing at birth and for some reasons, are subjected to either inadequate or no resuscitation at all. For all these reasons, there is an intense global focus on interventions for the estimated 10 million babies requiring assistance to initiate breathing [7, 8].

Around 85% of babies born at term initiate spontaneous respiration within 10 to 30 s of birth, an additional 10% require initial steps such as tactile stimulation or airway clearing or positioning [9‐13] and approximately 3% require positive-pressure ventilation by bag and mask [11, 13‐15]. Training in these basic resuscitation measures should be able to salvage 90% of the babies that do not initiate spontaneous respiration and is most needed in low resource settings where there is inadequate access to intrapartum and immediate post-partum care [13, 16, 17]. Helping Babies Breathe (HBB) is a simple hands-on training curriculum in basic newborn resuscitation for birth attendants [18]. The training focuses on appropriate resuscitation skills to be used within the first 60 s of life (the Golden Minute) including timely delivery of the essential interventions such as drying, providing warmth, and clearing the airway, providing additional stimulation to breathe and bag and mask ventilation, if needed. In past, studies have attempted to quantify the impact of resuscitation on new-born outcome and have shown the benefits of resuscitation training on newborn outcomes, including the Bang et al. study in which resuscitation training in India reduced the asphyxia-related mortality by 65% (p < 0.02, [19]). Carlo et al. used a “train-the-trainer” model to sequentially train midwives in urban, community health clinics in Zambia in Essential Newborn Care (ENC) and in the American Academy of Pediatrics Neonatal Resuscitation Program (NRP), and found a decrease in the all-cause 7-day neonatal mortality rates from 11.5 to 6.8 deaths per 1000 live births after ENC training, which was further lowered by NRP training. Recently the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network for Women’s and Children’s Health Research, and Research Triangle International (RTI) as the data coordinating center, conducted a pre-post study to evaluate the impact of HBB implementation in facilities serving rural communities (Maternal and Newborn Health Registry (MNHR)) located at three Global Network research sites - Nagpur and Belgaum in India and Eldoret in Kenya [18, 20]. MNHR enrolls pregnant women and records maternal and neonatal outcomes in catchment areas of rural primary health centers (study clusters). An additional file shows the flow diagram for the Nagpur Site of the Global Network HBB Implementation Study (GN-HBB-IS) [See Additional file 1]. All the births in the community based MNH registry were analyzed in the GN-HBB-IS. Around 45% of these did deliver in HBB trained facilities but rest delivered outside in other facilities. GN-HBB-IS did not find any effect of HBB implementation on day 7 perinatal mortality (PMR-D7). There are two plausible reasons for the failure to observe a reduction in PMR-D7 after facility-based health workers were trained in HBB implementation. Firstly, the reduction in PMR-D7 was estimated in all deliveries of pregnant women enrolled from the communities served by the trained facilities, not just those who delivered in HBB trained facilities. Secondly, the pre training period overlapped with the period of HBB training that was carried out in a step wise manner across the facilities and could have already started to reduce PMR-D7 in the pre-HBB implementation period (Table 1 and Additional file 1).

Since the GN-HBB-IS was not designed to evaluate facility based changes in day 1 perinatal mortality (PMR-D1), we planned this facility based study (Nagpur-HBB-FS) and collected data from the Nagpur facilities participating in GN-HBB-IS before any training had commenced and after the GN-HBB-IS training had been completed for all the births in the facilities irrespective of whether or not they belonged to the MNH registry. Our objective was to evaluate PMR-D1 in births occurring in facilities pre- compared to post- GN-HBB-IS implementation.

As shown in the flow diagram in Fig. 1, there were 78,948 births in the 13 HBB facilities in Nagpur – 38,078 in the pre-HBB and 40,870 in the post-HBB period. The majority of these births (71,489) took place in tertiary care facilities, 1731 took place in primary and 5728 in secondary facilities. Table 2 shows PMR-D1, SBR and NMR-D1 pre- and post-HBB, all of which were significantly reduced in the post-HBB period. The model yielded a significant incidence risk ratio (IRR) post to pre HBB of 0.85 (95% CI 0.73–0.98) for PMR-D1, of 0.86 (95% CI: 0.76–0.98) for SBR and of 0.79 (95% CI: 0.62–1.00) for NMR-D1. Figure 2 shows monthly PMR-D1, SBR and NMR-D1 pre- and post- HBB in the 13 facilities, all of which were significantly lower in the post vs. pre HBB period.

Among the PMR-D1, there was no significant difference in the pre vs post period for the baseline maternal and neonatal characteristics such as caesarian sections (10.8% vs 12.8%), prematurity (66.3% vs 68.2%), male gender (54.5% vs 53.2%), multiple gestations (7.3% vs 6.0%) and low birth weight (83.3% vs 86.8%). Maternal complications were present in 15.3% in pre and 11.1% in post period (p: 0.004).

This study showed that by focusing on day 1 perinatal and neonatal mortality just in trained facilities in one of the three GH-HBB-IS sites in Nagpur, India, HBB implementation significantly reduced PMR-D1 by 15.6%, SBR by 14.2% and NMR-D1 by 20.6%. By contrast, the NICHD GN-HBB-IS did not result in improvements in PMR-D7 in communities that were partially served by the facilities in which staff were trained in the GN-HBB-IS in the Nagpur or other GN sites [20]. There could be two likely reasons for this discrepancy. Firstly, there was an overlap of pre-HBB period and the training period in GN-HBB-IS which may have reduced PMR-D7 during the pre-period and may have led to the null result. Secondly, the GN-HBB-IS analyzed all births in a community-based registry. Around 45% of these births did take place in HBB trained facilities but the rest (more than 50% of babies) delivered outside in other facilities that were not trained in HBB implementation. Consequently, where the intervention did not happen, there was likely no effect and this diluted the effect in the overall population. In contrast the Nagpur-HBB-FS study analyzes ALL facility births- whether or not they belonged to the MNH registry- from 13 of the 15 facilities that had participated in the GN-HBB-IS. Since around 11% of these facility births belonged to the MNH registry, there was about 11% overlap in the births analyzed in GN-HBB-IS and Nagpur-HBB-FS (See Table 1, Fig. 1, and Additional file 1).

Similar to other studies, we also found a significant reduction in the SBR post HBB implementation, likely because HBB improves identification and resuscitation of neonates that appear to be lifeless at birth [23‐25].

The main strength of our Nagpur-HBB-FS is that it evaluated the direct impact of HBB implementation (HBB Training, equipment’s, and monitoring activities as explained in methods) with in a range of primary care facilities (where birth attendants may have minimal training) to tertiary care facilities (with high patient volumes and likely more complicated deliveries). Important limitations include lack of information on whether the study population changed in the pre to post period and the impact of HBB training on how perinatal mortality and stillbirths were recorded in the medical record in the two periods. Also, since many newborns get discharged from facilities before 7 days, in absence of any follow up information on the newborn’s status at home, we were unable to report PMR-D7 in the Nagpur-HBB-FS to assess whether the improvements seen in PMR-D1 were sustained through day 7.

So, where does this analysis fit in our understanding of the role of HBB implementation in neonatal resuscitation? Our study suggests that HBB improves PMR-D1 but may not translate to subsequent neonatal survival as the impact of neonatal resuscitation trainings on reduction of neonatal deaths will be highest for 1-day deaths and diminish subsequently. This fact has been endorsed in a recent meta-analysis of 20 studies that assessed impact of neonatal resuscitation trainings which showed a 42% reduction in 1-day mortality and 18% reduction in 7-day mortality [26]. Reduction of 28-days neonatal mortality will thus require, in addition to resuscitation trainings, provision of specialized care to the resuscitation survivors and various other existing intervention packages like improved hygiene at birth, breastfeeding and simple approaches to keep babies warm etc. [27, 28] as predominant causes of mortality after 24 h of life are prematurity, hypoxic ischemic encephalopathy, sepsis and congenital malformations [29, 30]. The GN-HBB-IS provides a bold target for where we need to go to improve global neonatal survival. Focus on facilities alone may not be sufficient to translate the gains achieved in neonatal survival to be generalized to population level gains.

This study addresses differences between facility based perinatal mortality rates on day 1 of life and community based perinatal mortality rates through day 7 of life. In this study (Nagpur-HBB-FS), facility based SBR, NMR-D1, and PMR-D1 were significantly lower after HBB implementation. In the previously published study (GN-HBB-IS), these facility based benefits did not translate to improvements in PMR-D7 in communities served by these facilities, possibly because all the community births did not occur in the facilities where HBB was implemented or because additional interventions are needed after day 1 of life. Benefits of HBB may thus be limited if births do not occur in facilities where HBB training has been provided. Increased access to facilities with HBB training will reduce perinatal mortality in that community.