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| Name | Class |
|---|---|
| Tufts University | OTHER |
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We seek to determine whether we can reduce day 28 mortality in Zambian newborns by training traditional birth attendants a modified version of the neonatal resuscitation protocol (NRP) and by improving their abiltiy to identify sepsis and initiate antibiotics in the field.
This is a cluster randomized trial of the impact of providing additional training and supplies to traditional birth attendants in a rural setting in Zambia. 120 TBAs are randomized into intervention/control. Intervention TBAs receive NRP training, supplies for neonatal resuscitation, receiving blankets for thermoregulation, and amoxicillin tablets. Control TBAs continue according to prior standard of care. Primary outcome is mortality at 28 days life as a proportion of births attended by TBAs in each study arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | TBAs who receive training and supplies for the intervention |
|
| control | Active Comparator | TBAs continuing with current standard of practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neonatal resuscitation protocol | Other | training in neonatal resuscitation and sepsis identification early treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| mortality | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| perinatal mortality | day zero | |
| sepsis mortality | deaths between days 1-28 | |
| cost effectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Gill, MD MS | Boston Universtiy | Principal Investigator |
| Grace Mazala, RN | Lufwanyama District Health Management Team | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22542215 | Derived | Gill CJ, Guerina NG, Mulenga C, Knapp AB, Mazala G, Hamer DH. Training Zambian traditional birth attendants to reduce neonatal mortality in the Lufwanyama Neonatal Survival Project (LUNESP). Int J Gynaecol Obstet. 2012 Jul;118(1):77-82. doi: 10.1016/j.ijgo.2012.02.012. Epub 2012 Apr 27. | |
| 21292711 | Derived | Gill CJ, Phiri-Mazala G, Guerina NG, Kasimba J, Mulenga C, MacLeod WB, Waitolo N, Knapp AB, Mirochnick M, Mazimba A, Fox MP, Sabin L, Seidenberg P, Simon JL, Hamer DH. Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study. BMJ. 2011 Feb 3;342:d346. doi: 10.1136/bmj.d346. |
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| ID | Term |
|---|---|
| D001238 | Asphyxia Neonatorum |
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018805 | Sepsis |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Other | continued with current standard of care for birth attendants |
|
| days 0-28 |
| successful delivery of nevirapine prophylaxis to HIV exposed deliveries | day zero umbilical cord dried blood spot |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |