Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled studyBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d346 (Published 03 February 2011) Cite this as: BMJ 2011;342:d346
- Christopher J Gill, assistant professor of international health1,
- Grace Phiri-Mazala, national programmes director, Zambian Anglican Council2,
- Nicholas G Guerina, assistant professor of paediatrics13,
- Joshua Kasimba, researcher27,
- Charity Mulenga, nurse midwife2,
- William B MacLeod, assistant professor of international health14,
- Nelson Waitolo, public health officer4,
- Anna B Knapp, senior project manager1,
- Mark Mirochnick, professor of paediatrics5,
- Arthur Mazimba, field director7,
- Matthew P Fox, assistant professor of international health18,
- Lora Sabin, assistant professor of international health14,
- Philip Seidenberg, assistant professor of international health17,
- Jonathon L Simon, chair and professor of international health14,
- Davidson H Hamer, professor of international health and medicine146
- 1Center for Global Health and Development, Boston University, Boston, MA, USA
- 2Lufwanyama District Health Management Team, Kalulushi, Zambia
- 3Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, MA, USA, and Department of Paediatrics, Women and Infants Hospital, Providence, Rhode Island, USA
- 4Department of International Health, Boston University School of Public Health, Boston, MA, USA
- 5Department of Pediatrics, Boston University School of Medicine, Boston, MA, USA
- 6Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine
- 7Center for International Health and Development Zambia (CIHDZ), Lusaka, Zambia
- 8Department of Epidemiology, Boston University School of Public Health
- Correspondence to: C J Gill
- Accepted 7 December 2010
Objective To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a resource poor country with limited access to healthcare.
Design Prospective, cluster randomised and controlled effectiveness study.
Setting Lufwanyama, an agrarian, poorly developed district located in the Copperbelt province, Zambia. All births carried out by study birth attendants occurred at mothers’ homes, in rural village settings.
Participants 127 traditional birth attendants and mothers and their newborns (3559 infants delivered regardless of vital status) from Lufwanyama district.
Interventions Using an unblinded design, birth attendants were cluster randomised to intervention or control groups. The intervention had two components: training in a modified version of the neonatal resuscitation protocol, and single dose amoxicillin coupled with facilitated referral of infants to a health centre. Control birth attendants continued their existing standard of care (basic obstetric skills and use of clean delivery kits).
Main outcome measures The primary outcome was the proportion of liveborn infants who died by day 28 after birth, with rate ratios statistically adjusted for clustering. Secondary outcomes were mortality at different time points; and comparison of causes of death based on verbal autopsy data.
Results Among 3497 deliveries with reliable information, mortality at day 28 after birth was 45% lower among liveborn infants delivered by intervention birth attendants than control birth attendants (rate ratio 0.55, 95% confidence interval 0.33 to 0.90). The greatest reductions in mortality were in the first 24 hours after birth: 7.8 deaths per 1000 live births for infants delivered by intervention birth attendants compared with 19.9 per 1000 for infants delivered by control birth attendants (0.40, 0.19 to 0.83). Deaths due to birth asphyxia were reduced by 63% among infants delivered by intervention birth attendants (0.37, 0.17 to 0.81) and by 81% within the first two days after birth (0.19, 0.07 to 0.52). Stillbirths and deaths from serious infection occurred at similar rates in both groups.
Conclusions Training traditional birth attendants to manage common perinatal conditions significantly reduced neonatal mortality in a rural African setting. This approach has high potential to be applied to similar settings with dispersed rural populations.
Trial registration Clinicaltrials.gov NCT00518856.
We thank Victoria J Guerina for illustrating the reference cards.
Contributors: CJG was the principal investigator, conceived the project, identified the site, was closely involved in the design of the protocol and data collection tools, provided much of the study monitoring, played a lead role in the analysis, and wrote the manuscript. GP-M was the Zambian principal investigator, led the field team, provided primary oversight during the study, contributed to the protocol design and data cleaning, and was instrumental in the analysis and reporting of the study. NGG was chiefly responsible for designing the neonatal resuscitation protocol curriculum and participated in training of the birth attendants throughout the study, participated in protocol development and development of data tools, contributed to the sepsis protocol and trainings, data analysis, cleaning, and manuscript preparation. JK was the field manager during the study. He supervised the 16 data collectors, provided logistical support, was involved in the data collection and cleaning process, supervised the final cleaning and locking of the dataset, and participated in the analysis of the study. CM was the chief trainer of the neonatal resuscitation protocol/antibiotics with facilitated referral of the birth attendants, and also provided technical support to the field team during the study. WBMacL was the study statistician and was involved in all aspects of the design, data management and analysis, and writing of the manuscript. NW was the field data manager, participated in the protocol design, supervised the data entry and cleaning process, and set up the database in the field. ABK was the Boston based project manager for LUNESP, participated in the data cleaning process, provided in-field technical assistance throughout the study, and was actively involved in the analysis and writing of the manuscript. MM provided technical assistance during the neonatal resuscitation protocol training, was closely involved in the design of the prevention of maternal to child transmission of HIV component to LUNESP (data to be presented separately), and actively participated in the analysis and writing of this manuscript. AM provided technical support to the field team from the BU field office in Lusaka, was instrumental in the data cleaning process, and also provided thoughtful input on the manuscript. MPF worked closely with WBM on the statistical analysis of LUNESP and was closely involved in the writing of the manuscript. LS was chiefly responsible for the design of the cost effectiveness and cost analysis portions of LUNESP (to be presented separately), and was active in the overall protocol design, analysis, and writing of the manuscript. PS supervised the BU field office in Lusaka, provided important technical support to the Lufwanyama field team, was actively involved in the data cleaning, and provided thoughtful input to the manuscript. JLS secured the funding for the project and contributed to the design, monitoring, and reporting of the study. DHH was actively involved at every stage of LUNESP, from protocol design to study implementation, data cleaning, analysis, and writing of the manuscript. CJG and WBMacL are guarantors.
Funding: This work was supported by a cooperative agreement between Boston University and the Office of Health and Nutrition of the United States Agency for International Development, GHS-A-00-03-00020-00. NIH/NIAIDS K23 AI 62208 supported CJG’s effort. Additional support for the neonatal resuscitation protocol intervention was provided by a neonatal resuscitation programme grant from the American Academy of Pediatrics, which also defrayed some of the costs of NGG’s travels to Zambia, some of the field office expenditures, and purchase of some of the safe delivery kits. UNICEF kindly provided some of the other safe delivery kits. None of the funding agencies played any role in the analysis or reporting of these results.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the ethics committees at Boston University Medical Center and the Tropical Diseases Research Centre, Ndola, Zambia.
Data sharing: The full protocol can be provided on request from the corresponding author at.
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