Background

The focus of this review is the impact of a healthcare provider (HCP) training program on newborn outcomes. Within the Sustainable Development Goals1 and the Global Strategy for Women's, Children's and Adolescents' Health,2 there is a significant focus on scaling up and improving maternal, child and newborn health around the world. While the Millennium Development Goals did result in a reduction of under-five mortality, decreasing from 90 to 43 deaths per 1000 live births between 1990 and 2015,3 there is still much work that needs to be done. In developing regions, the percentage of birth being attended by a skilled HCP ranges from 87% in urban areas to only 56% in rural areas.3 At the end of 2015, every region of the world reported an increase in the number of deaths that occurred during the neonatal period in proportion to under-five mortality rates.3 This is a critical challenge as 98% of all neonatal deaths occur in low-resource countries,4,5 yet many neonatal deaths can be prevented through low-cost, highly effective interventions addressing essential newborn needs.3

The newborn period is highly vulnerable. Approximately one million infants will die within the first day of life, another one million will die within the first week and another almost two million will not survive beyond the first 28 days (known as the neonatal period).3 The leading causes of death during the neonatal period include pre-term birth complications (35%), complications during labor and delivery (24%), and sepsis (15%).3 An additional three million stillbirths occur each year. This problem poses a particular challenge in low-resource areas where information is unreliable and there is lack of skills to distinguish between true stillbirth, defined as death by a viable fetus prior to the onset of labor, and fresh stillbirth, defined as death by a viable fetus during the period between onset of labor to the end of the third stage of labor whereby the fetus may benefit from resuscitation efforts.6,7 Approximately 16 million infants require some assistance to initiate breathing upon birth, ranging from tactile stimulation (e.g. rubbing) or airway clearing (5-10%) to bag-and-mask ventilation (3-6%).8,9 In low-resource areas, newborn resuscitation faces many challenges including low-skill birth attendants6 and inadequate training opportunities.10 To improve neonatal outcomes, it is essential that HCPs are adequately trained. In high-resource countries, training programs focused on skilled providers such as the Neonatal Resuscitation Program in the United States have resulted in a reduction in neonatal morbidity and mortality through standardized training and skill development.11

To address the lack of basic resuscitation training in health facilities in low-resource areas and improve neonatal outcomes, a newborn care training program targeting HCPs called Helping Babies Breathe (HBB) was developed in 2010 by the American Academy of Pediatrics and their partners.10,12 The program, based on World Health Organization guidelines,13 was developed to train skilled birth attendants in low-resource areas in basic newborn resuscitation, including maintaining temperature, cutting the umbilical cord, assessing respiration and stimulation, clearing the airway and engaging in ventilation, if necessary.4 Helping Babies Breathe is the leading example of evidence-based educational training for skilled HCPs on essential care for at-risk newborns in low-resource countries to improve maternal and neonatal care globally.4,10 Helping Babies Breathe utilizes the World Health Organization's definition of skilled birth attendant, as "an accredited health professional - such as a midwife, doctor or nurse - who has been educated and trained to proficiency in the skills needed to manage normal (uncomplicated) pregnancies, childbirth and the immediate postnatal period, and in the identification, management and referral of complications in women and newborns".14^(p.1) According to their five-year report published in July 2015, HBB has been rolled out in over 77 countries from 2010 to 2014 and uses a "train-the-trainer" model, whereby seasoned personnel guide inexperienced instructors through a structured hands-on training program to receive coaching and mentoring to develop skills and knowledge, which they can in turn use to train others.10

After four years of reducing newborn mortality through HBB, it became clear that a broader mandate was needed to eliminate all preventable newborn deaths.6,10 Therefore, the Helping Babies Survive suite of programs was expanded to include Essential Care for Every Baby15 and Essential Care for Small Babies.16 Covering the period immediately after birth, Essential Care for Every Baby focuses on care provided throughout the first day of the newborn's life until the time of discharge, and is aimed at reinforcing skills related to maintaining infant warmth, immediate skin-to-skin care, early breastfeeding, umbilical cord care, eye care, vitamin K injections and immunization.14 Essential Care for Small Babies focuses on interventions that support the needs of late preterm and low-birthweight babies after birth until discharge or transfer to another facility, and is aimed at training HCPs on how to keep infants warm through skin-to-skin contact and adequate feeding techniques through proper breastfeeding positioning and attachment, correct nasogastric placement, and training in spoon, cup and nasogastric tube feeding.15

Essential Care for Every Baby and Essential Care for Small Babies incorporate the same skill-based learning using simulation, learning exercises and peer-to-peer training as HBB.17 The first program evaluation of Essential Care for Every Baby was conducted by Thukral et al.17 in India and Kenya which found that HCPs who participated in the course felt that the structure and content of the material were appropriate and applicable to their environment. They also found that HCPs gained confidence, knowledge and skills.17 The Helping Babies Survive program now has the objective of addressing all major causes of newborn death including asphyxia, infections and complications related to pre-term/low-birthweight.10 The Helping Babies Survive modules address areas which evidence has found to reduce neonatal deaths, including skin-to-skin contact, early breastfeeding, temperature maintenance, and prevention and treatment of infections.6 With these increased modules, Helping Babies Survive has shifted the focus toward sustainability and impact, rather than rapid rollout.10

Despite the number of studies that have been conducted on HBB7,18-20 as well as ongoing analysis of the subsequent modules (Essential Care for Every Baby17 and Essential Care for Small Babies), there has been no systematic review of the Helping Babies Survive program to date. The following databases - MEDLINE, CINAHL, PROSPERO, Epistemonikos and Cochrane - were searched for existing systematic reviews on this topic, and no review was located. PROSPERO brought up a systematic review protocol on HBB in 2014; however, it was conducted as a Masters dissertation and was not published. Furthermore, this review only evaluated HBB, rather than the entire Helping Babies Survive suite of modules. Reisman et al.11 recently conducted a systematic review on newborn resuscitation training in resource-limited settings and found that training can significantly improve provider knowledge and skills in HCPs present at birth. However, this review did not explore the impact on neonatal mortality rates, and it focused on neonatal resuscitation training programs alone.11 Therefore, the current review will expand on the gaps of these two reviews by including both HCP and neonatal outcomes as well essential newborn care beyond neonatal resuscitation. As the Helping Babies Survive program continues to be used in low-resource countries, it is important to evaluate its impact on neonatal outcomes, HCPs knowledge and skills, and sustainability.

Inclusion criteria

Types of participants

The current review will consider studies that include HCPs providing essential neonatal care at and post-birth. Healthcare providers will include both skilled and non-skilled healthcare staff and/or birth attendants present and providing care at and post-birth (e.g. nurses, doctors, midwives and community health providers). Despite Helping Babies Survive having a primary focus on training skilled health providers, both skilled and non-skilled HCPs will be included as it is stated on the Helping Babies Survive website that in certain circumstances, the Helping Babies Survive program may be successfully taught to traditional birth attendants as well.21

Types of intervention

The current review will consider studies that evaluate the effectiveness of the Helping Babies Survive curriculum (HBB, Essential Care for Small Babies and Essential Care for Every Baby), alone or in combination with additional HCP training.

Outcomes

The current review will consider studies that include the following outcome measures: neonatal outcomes and/or HCP knowledge and skills obtained and maintained over time. Neonatal outcomes to be considered include the following:

* Mortality rates, defined as death within the first seven or 28 days of life

* Stillbirth rates, defined as death by a viable fetus prior to the onset of labor7

* Fresh stillbirth rates, defined as death by a viable fetus during the period between onset of labor to the end of the third stage of labor7

* First-day mortality, defined as mortality with 24 hours after birth

* Score or intervention related to Stabilization and feeding, including Apgar score, breastfeeding within the first 24 hours, use of skin-to-skin contact and temperature monitoring

Healthcare provider knowledge and skills to be considered include the following:

* Successful use of bag mask ventilation within one minute of birth, defined as during and/or after HBB training

* Skill, as reported through Objective Structured Clinical Evaluation performance

* Knowledge, as reported through multiple choice questionnaires

* Confidence, as reported through confidence surveys or interviews

* Use of simulated training within the hospital setting, reported as adherence to training demonstrated by direct observation by an evaluator or by other methods of documentation

* Course evaluation, as reported through surveys or interviews.

Types of studies

The current review will consider both experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case-control studies and analytical cross-sectional studies for inclusion.

Search strategy

The search strategy aims to find both published studies and unpublished reports. A three-step search strategy will be utilized in this review. An initial limited search of PubMed and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all identified keywords and index terms will then be undertaken across all included databases (Embase, ProQuest, SCOPUS and Web of Science). Third, the reference list of all identified reports and articles will be searched for additional studies. Studies published in English will be considered for inclusion in this review. Studies published in or after 2010 will be considered for inclusion in this review as the first module, HBB, was launched then.

The databases to be searched include PubMed, Embase, Web of Science, ProQuest, Scopus and CINAHL. The search for unpublished reports will include reviewing the http://www.helpingbabiesbreathe.org website for additional articles as well as reports available through the HBB Global Development Alliance. Gray literature findings will be manually sorted to include only reports that provide measured neonatal outcomes or HCPs' knowledge and skills. Sources of report content will be screened to ensure that no duplication of primary data is included in review. Authors will also contact the American Academy of Pediatrics to seek any additional published studies that may not have come up in the literature review. However, unpublished studies or reports will not be included in the analysis as the work has not been peer-reviewed.

Initial keywords to be used will be "HBB" OR "Essential Care for Every Baby" OR "Essential Care for Small Babies" OR "Helping Babies Survive" OR "essential newborn care."

Assessment of methodological quality

Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion or with a third reviewer.

Data extraction

Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Authors of primary studies will be contacted for clarification or missing information as needed.

Data synthesis

Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the different study designs included in this review. Where statistical pooling is not possible, the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate. Each program will be evaluated together and separately as applicable, based on the outcomes reported in the studies. Sub-analysis will be conducted, if applicable, to determine on potential variations in outcomes between countries, continents and income according to the World Bank.22 Additional sub-analysis will be conducted, if applicable, on neonatal outcomes including gestational age and between skilled and non-skilled HCPs.

Acknowledgements

The authors would like to thank the Queen's Collaboration for Health Care Quality for the training provided to the primary author for the development of this protocol. The authors would also like to thank Queen's Librarian Amanda Ross-White for her assistance search strategy development during JBI training in October, 2016. JD is funded through the Nova Scotia Health Research Foundation (Scotia Scholar and Scotia Support) and Dalhousie University (Nova Scotia Graduate Scholarship) as a PhD in Health trainee at Dalhousie University. MCY is funded through the Canadian Child Health Clinician Scientist Program Career Development and Canadian Institute of Health Research New Investigator.

Appendix I: Appraisal instruments

MAStARI appraisal instrument

Appendix II: Data extraction instruments

MAStARI data extraction instrument

References