Abstract
BACKGROUND AND OBJECTIVE: Newborns are at the highest risk of dying around the time of birth, due to intrapartum-related complications. Our study’s objective was to improve adherence to the Helping Babies Breathe (HBB) neonatal resuscitation protocol and reduce perinatal mortality by using a quality improvement cycle (QIC) in a tertiary hospital in Nepal.
METHODS: The HBB QIC was implemented through a multifaceted approach, including the formation of quality improvement teams; development of quality improvement goals, objectives, and standards; HBB protocol training; weekly review meetings; daily skill checks; use of self-evaluation checklists; and refresher training. A cohort design, including a nested case-control study was used to measure changes in clinical outcomes and adherence to the resuscitation protocol through video recording, before and after implementation of the QIC.
RESULTS: The intrapartum stillbirth rate decreased from 9.0 to 3.2 per thousand deliveries, and first-day mortality from 5.2 to 1.9 per thousand live births after intervention, demonstrating a reduction of approximately half in the odds of intrapartum stillbirth (adjusted odds ratio [OR] 0.46, 95% confidence interval [CI] 0.32–0.66) and first-day mortality (adjusted OR 0.51, 95% CI 0.31–0.83). After intervention, the odds of inappropriate use of suction and stimulation decreased by 87% (OR 0.13, 95% CI 0.09–0.17) and 62% (OR 0.38, 95% CI 0.29–0.49), respectively. Before intervention, none of the infants received bag-and-mask ventilation within 1 minute of birth, compared with 83.9% of infants after.
CONCLUSIONS: The HBB QIC reduced intrapartum stillbirth and first-day neonatal mortality and led to use of suctioning and stimulation more frequently. The HBB QIC requires further testing in primary settings across Nepal.
- ANC —
- antenatal care
- CI —
- confidence interval
- HBB —
- Helping Babies Breathe
- OR —
- odds ratio
- QIC —
- quality improvement cycle
- QIT —
- quality improvement team
The time between a hypoxic event during labor or delivery and death can be short; an infant who does not breathe at birth could die in less than an hour.1 Globally, an estimated 1.2 million stillbirths occur after the onset of labor and 1 million live-born infants die on their birth day, indicating the importance of timely, high-quality care around the time of birth.2,3 In Nepal, 36% of neonatal deaths are due to intrapartum-related complications and 23% of stillbirths occur during the intrapartum period.1
The first minute after an infant is born is the crucial window for neonatal resuscitation for the 10 million nonbreathing infants born annually.4 Resuscitation training in facilities can reduce intrapartum-related neonatal deaths by 30%.5 A basic neonatal resuscitation protocol called Helping Babies Breathe (HBB) has been developed for use in low-resource settings.6,7 It was designed to improve health workers’ awareness of the need to initiate neonatal resuscitation within the so-called “Golden Minute,” to improve their clinical skills, and to increase adherence to neonatal resuscitation protocol.
Given the context of inadequate use of neonatal resuscitation and care at the time of birth at Paropakar Maternity and Women’s Hospital, and with the availability of the HBB protocol for neonatal resuscitation, we developed and implemented a quality improvement cycle (QIC).1 Our objective was to improve adherence to the HBB neonatal resuscitation protocol and reduce perinatal mortality by using a QIC in a tertiary hospital in Nepal.
Methods
Ethical Consideration
This study was approved by the hospital’s institutional review committee, Nepal Health Research Council, and Uppsala University, and was registered as a clinical trial.8
Study Design
All women delivering at ≥22 weeks of gestation in the hospital during the study period were included in the study. A prospective cohort study was conducted to evaluate the change in mortality and stillbirth rate before and after implementation of the HBB QIC. A case-control design was nested within this cohort to evaluate the odds of change in mortality before and after implementation of the HBB QIC. For the nested case-control design, all women with stillbirths and neonatal deaths were included as cases and 20% of women were randomly selected to be controls on admission. Any woman with a death or stillbirth in the control population was recategorized and included in the case population. The random selection of women for the control population was done by using a lottery technique at the time of admission. The lottery was done by using an opaque jar with 20 yellow balls and 80 white balls; for each woman admitted for delivery a ball was drawn, if a yellow ball was selected, the woman was selected as the control population. To evaluate the change in health worker performance of neonatal resuscitation by using video recording, all the infants of the control population were taken.
Setting
Paropakar Maternity and Women’s Hospital is a tertiary hospital with 415 beds, providing obstetric and gynecologic services in Kathmandu, Nepal. In 2012, there were ∼22 000 deliveries at the hospital, with a stillbirth rate of 19 per 1000 deliveries and an early neonatal mortality rate of 9 per 1000 live births.9 Three units are assigned to provide delivery services: the Maternal and Newborn Service Center, the Labor Room, and the Operation Theater. The 3 units each have a different mix of human resources (Table 1).
Human Resources and Set-up of Each Delivery Unit
This study comprised 2 phases. The first was a baseline period from July until December 2012 that also included the planning of the QIC for HBB. The second phase was the implementation of the HBB QIC from January until September 2013.
Planning of the QIC
In November 2012, the process of development of HBB QIC was initiated with a workshop with hospital leadership to review the current adherence to neonatal resuscitation and develop interventions to improve practice. A quality improvement team (QIT) was formed to develop a QIC to improve adherence to neonatal resuscitation with staff at each delivery unit. The QIT finalized the QIC as HBB QIC, which included HBB training, weekly review and reflection meetings, daily bag-and-mask skill checks, self-evaluations, peer review of the HBB protocol adherence, daily debrief, and refresher training. Please refer to Table 2 for detail of process of development of HBB QIC.
Process for Development of HBB QIC and Detail of Activities, Facilitators, and Participants Involved in Each Component of HBB QIC
Implementation of HBB QIC
From the first week of January 2013, the HBB QIC implementation was initiated with a 2-day training on the HBB QIC. Directly after the training, bag-and-mask kits and penguin suction devices were provided to each delivery unit. Additionally, an HBB mannequin was placed at the entry of each delivery unit for daily skill checks; self-evaluation checklists were attached to each clinical record form; and HBB schematic posters were placed in front of each resuscitation table for peer review. Weekly review and reflection meetings were conducted to discuss progress on the implementation of HBB QIC standards. During the daily debriefing by the unit in-charge to the QIT, the progress on implementation of QIC standards was reviewed. HBB refresher training was conducted after 6 months with staff in all delivery units.
Measures
Outcome measures included perinatal mortality, stillbirth, antepartum stillbirth, intrapartum stillbirth, and first-day neonatal mortality (Table 3). The process outcomes related to clinical adherence included use of stimulation or suction and initiation of bag-and-mask ventilation within 60 seconds of birth.
Definition of Primary Outcomes
For data collection, a surveillance system was established in the admission, delivery, and postnatal units. Twelve surveillance officers who were trained on tracking, data retrieval, and interviews were stationed in these units 24 hours a day. Data on obstetric history, intrapartum and postpartum clinical progress, and outcomes for the case and control populations were retrieved from clinical journals. Information on the infant’s birth weight, gestational age, Apgar score at 1 and 5 minutes, and gender was collected. Interviews were conducted with mothers to obtain information on education, socioeconomic background, and antenatal care (ANC) attendance.
To evaluate clinical adherence, a motion-triggered video recorder was mounted on the radiant warmer above each resuscitation table. The recorder was positioned to provide a field of view that included the entire infant but only the hands of resuscitation team members. It was connected to a 24-hour clock to time-stamp images. Surveillance officers who were trained in reviewing the tapes evaluated the immediate care of infants who were brought to the table for resuscitation. The evaluation was based on a video-record form, which included time of delivery, time the infant was brought to the table, use of suction and/or stimulation and their duration, time when bag-and-mask ventilation began and duration of ventilation, additional resuscitation measures provided, and time of the newborn’s first cry. To reduce interobserver variation, a blinded assessment of video recording was done for each of the control group infants by a second officer.10
All the record forms, interviews, and video-record forms were reevaluated by a research coordinator (RV) and rechecked for discrepancies by a data entry officer before data entry occurred. Ten percent of all forms were verified against the primary source of data. Census and Survey Processing System was used for data entry and a data management officer cleaned the data before transferring it into the Statistical Package for the Social Sciences (IBM SPSS Statistics, IBM Corporation, Chicago, IL) for statistical analysis. To ensure data privacy, each control and case population participant was recoded and indexed. Video records were backed up every week to prevent data loss. An independent data-monitoring committee, which was formed before the study started in June 2012, performed quarterly reviews of interim data for completeness, quality, and adherence to ethical requirements.
The background characteristics were categorized as follows. Maternal education was categorized as secondary education or higher versus primary school or lower. Wealth quintile was categorized as a measure of socioeconomic position, constructed as 1 to 5 with first being the poorest and fifth being the wealthiest.11–13 A binary variable was then created to categorize women as poor (ie, those belonging to the poorest quintile) and nonpoor, and those belonging to any of the other 4 quintiles for regression analysis. Maternal age was categorized into 5-year interval categories; parity as primiparous, multiparous (1–2), or multiparous (≥3); ANC attendance, as having attended the recommended 4 (or more) visits compared with <4; gender as boys or girls; number of births as singleton or multiple; birth weight as <1500, 1500–2499, or ≥2500 g; and gestational age as ≤32, 33–36, or ≥37 weeks, based on last menstrual period.
Analysis
A power analysis based on the prestudy perinatal mortality and delivery rate at the hospital indicated that a reduction of 20% in perinatal mortality would be detectable within the set time frame (α 0.05, β 0.20).
Pearson’s χ2 test was used to compare stillbirth and mortality rates among the cohort population during the baseline and intervention periods. Background characteristics of the control population were compared between baseline and intervention groups by using Wilcoxon rank-sum tests and Pearson’s χ2 test. Statistical significance was decided at P < .05.
Multiple logistic regression analysis was used to determine if the implementation of the HBB QIC was associated with a change in outcome measures of cases, compared with the control population. To create the multiple logistic regression models, adjustments were made for the background characteristics that were significantly different between the baseline and intervention control populations. Univariate logistic regression analysis was conducted within the control population to identify any change in health workers’ practice of neonatal resuscitation after implementation of HBB QIC.
We used run charts to assess outcome measures on intrapartum stillbirth rate, first-day neonatal mortality, and bag-and-mask ventilation within 1 minute on a monthly basis over the time with the median line. The run charts were annotated with the activities conducted during different times. For missing data, a multiple imputation method was used.14
Results
The run charts showed the decline in the intrapartum stillbirth and first-day neonatal mortality rates (Fig 1) and the increase in the bag-and-mask ventilation within 1 minute (Fig 2), in relation to the introduction of different HBB QIC activities. In the first 3 months of the intervention period, there was a sharp decline in mortality when the HBB QIC training and HBB QIC were conducted. This change was sustained until 6 months, when the HBB QIC was continued. There was a slight decline in mortality and a slight increase in bag-and-mask ventilation within 1 minute when the refresher HBB training was conducted in the seventh month, and when other HBB QIC components were continued.
Flowchart showing the baseline and intervention populations.
The run chart. The intrapartum stillbirth rate, first-day neonatal mortality rate on a monthly basis over time with median line. The run chart is annotated with the activities conducted during different times.
A total of 9588 and 15 520 deliveries took place at the hospital in the baseline and intervention periods, respectively (Fig 3). During this study, perinatal mortality was lower in the intervention than in the baseline period (23.3 vs 30.9/1000 deliveries). A total of 443 stillbirths occurred throughout both periods, of which 307 were antepartum stillbirths and 136 were intrapartum stillbirths. The intrapartum stillbirth rate was lower in the intervention period compared with baseline (3.2 vs 9.0/1000 deliveries). The first-day mortality rate decreased from 5.2 to 1.9 per 1000 live births from the baseline to the intervention period. During the study period, 299 neonatal deaths occurred, with 209 dying in the first 7 days of life and 78 in the first 24 hours (Table 4).
The run chart. The percentage of bag-and-mask ventilation within 1 minute on a monthly basis over time with median line. The run chart is annotated with the activities conducted during different times.
Birth Outcomes in Baseline and Intervention Populations Among the Cohort Population
During the baseline and intervention periods, 488 and 588 infants were resuscitated, respectively, in the control population. The odds of performing stimulation or suction decreased by 62% (odds ratio [OR] 0.38, 95% confidence interval [CI] 0.29–0.49) and 87% (OR 0.13, 95% CI 0.09–0.17), respectively, after HBB QIC implementation. The odds for bag-and-mask ventilation increased >2 times (OR 2.56, 95% CI 1.67–3.93) (Table 5). In the control population, during the baseline period, none of the nonbreathing infants (0/31) received bag-and-mask ventilation within 1 minute. In the control population, during the intervention period, 83.9% (73/87) of the infants received ventilation within 1 minute.
Use of Stimulation, Suction, and Bag-and-Mask Before and After HBB QIC Among the Control Population That Received Resuscitation Observed by Using Video (Charge-Coupled Device) Recording
During the entire study period, 4891 women were selected to be part of the control group. Of them, 360 women were discharged without delivery and therefore the control population included 4531 deliveries. Comparison of the background characteristics for the 1903 and 2628 women in the baseline and intervention control population groups showed no differences in maternal education, wealth status, ethnicity, maternal age, parity, gender of newborn, number of newborns, or birth weight. The baseline and intervention control populations were different in attendance of ANC visits and gestational age of the infant (Table 6).
Background Characteristics of the Control Population (n = 4531) During the Baseline and Intervention Periods
Multiple regression analysis was conducted to assess the change in outcome measures before and after implementation of the HBB QIC. The analysis showed that the risk for intrapartum stillbirth decreased by 54% (adjusted OR 0.46, 95% CI 0.32–0.66), and for first-day neonatal mortality by 49% (adjusted OR 0.51, 95% CI 0.31–0.83), after adjusting for ANC attendance and gestational age. There was no change in overall stillbirth or neonatal mortality after adjusting for potential confounders (Table 7).
Risk of Mortality Outcomes Before and After HBB Intervention in the Case-Control Population
Discussion
We demonstrated that the implementation of an HBB QIC was associated with an improvement in the adherence of health workers’ practice to neonatal resuscitation protocols, with reduction in intrapartum stillbirth and first-day neonatal mortality. The current study further demonstrated the association between implementation of an HBB QIC and a decline in the overuse of suctioning and stimulation in breathing infants, as well as in those nonbreathing infants, for which the health worker moved more quickly to initiate bag-and-mask ventilation. This is the first study that provided, through the use of video recordings, clear evidence on the improvement of health workers’ performance after intervention. Bag-and-mask ventilation within the Golden Minute increased by 84% from before to after implementation. Most importantly, we demonstrated that a quality improvement approach to enhance neonatal resuscitation practices in a tertiary hospital is feasible and can result in substantial improvement in clinical outcomes. The overall neonatal mortality rate did not appear to have been impacted by the intervention, suggesting more effective intervention to be implemented beyond the immediate newborn period to change the overall outcome.
A previous study looking at the impact of the implementation of an HBB program in health facilities in Tanzania found a significant reduction in the rate of intrapartum stillbirth (relative risk 0.76, 95% CI 0.64–0.90).15 Similarly, another study from India found that implementation of HBB training was associated with a significant reduction in intrapartum stillbirth (OR 0.54, 95% CI 0.37–0.78).16 The reduction of intrapartum stillbirths in both of these studies was less pronounced, however. This is potentially due to the QIC component in our study, as the HBB protocol was continuously reinforced throughout the intervention period. Furthermore, the combination of a reduction in unnecessary practices with the timely initiation of indicated assisted ventilation suggests retention and fidelity of resuscitation techniques at a higher level than previously reported.16
Our study has some limitations. First, as a prospective cohort study with a nested case-control design, we can make inferences on the association between the intervention and the desired effects; however, causation cannot be established. Second, a package of interventions made up the QIC, and thus we could not unbundle the package to demonstrate the association of individual components with the outcome. Third, there might have been measurement bias based on the inaccurate identification and/or documentation of an infant as stillborn rather than live-born with neonatal death, thus leading to differential misclassification of individual outcomes and exposures. Multivariate logistic regression analysis was used to control the potentially confounding background characteristics that were significantly different between baseline and intervention control populations. Additionally, because the surveillance officers were aware of the study hypothesis, there might have been selective gathering of interview data, either consciously or subconsciously.
There are several potential reasons that we were able to improve adherence to neonatal resuscitation by using the HBB QIC approach. First, the hospital leadership recognized the inadequate adherence to standard protocols within the hospital, and thus identified a need for change. Furthermore, the multidisciplinary QIT, which included hospital staff members, was responsible for developing the quality improvement plan and conducting daily debriefings of the HBB QIC implementation progress. There are several previous studies that have shown that leadership plays a crucial role in the quality improvement process.17,18
Second, the unit-based review and reflection on the root causes of poor performance of neonatal resuscitation and development of the quality improvement goals, objectives, and standards, allowed individual health workers to discuss their experiences and to be involved in the creation of the QIC. This process can create an environment that is conducive for implementing a quality improvement plan and for building teamwork.19–21 Third, the introduction of self-evaluation checklists, in general, can improve compliance with best clinical practice.22 And finally, the HBB QIC progress boards placed in each unit provided a constant reminder to the staff of the quality improvement effort. Displaying data on implementation progress at each nursing station, in each delivery unit, allowed for constant review of and identification of potential problems in the implementation of the QIC, which has also been demonstrated in other quality improvement studies.20,22
A cost-effectiveness evaluation of an HBB program in a hospital of Tanzania revealed that HBB is a low-cost intervention.23 The HBB QIC as implemented in our study is also an affordable intervention.
Conclusions
This study in Nepal has demonstrated a significant reduction in intrapartum stillbirth and first-day neonatal mortality, as well as an increased adherence to the HBB protocol among health workers at a tertiary hospital. A new approach for improving clinical performance for neonatal resuscitation by using an HBB QIC has been identified and can be readily implemented in similar hospital settings. Further studies evaluating whether the HBB QIC can improve the performance of health workers in district hospitals and peripheral health facilities are needed.
Acknowledgments
We thank Viktoria Nelin for providing editorial assistance to finalize the article. We thank Dr Arjun Karki, Dr Chop L. Bhusal, Dr Dhan R. Aryal, Dr Sheela Verma, Dr Jyoti R. Dhakwa, Dr Naresh P. KC, Dr Kamal R. Sharma, and Dr Geha Nath Baral for their input in the study protocol and design. We thank Ms Maiya Manandhar and her team for leading the training of trainers for HBB. We also sincerely acknowledge Mr Amar Amatya, the surveillance officers, data entry officers, and data management officer for their efforts in making this study possible.
Footnotes
- Accepted January 4, 2016.
- Address correspondence to Ashish KC, MBBS, MHCM, PhD, International Maternal and Child Health, Department of Women’s and Children’s Health, University Hospital SE-751 85, Uppsala, Sweden. E-mail: aaashis7{at}yahoo.com
This trial has been registered with the ISRCTN Register (http://isrctn.org) (identifier ISRCTN97846009).
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.
FUNDING: Funded by the Laerdal Foundation for Acute Medicine and Swedish Society of Medicine.
References
- Copyright © 2016 by the American Academy of Pediatrics
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