Lufwanyama Neonatal Survival Project (LUNESP)

• perinatal mortality [ Time Frame: day zero ]
• sepsis mortality [ Time Frame: deaths between days 1-28 ]
• cost effectiveness [ Time Frame: days 0-28 ]
• successful delivery of nevirapine prophylaxis to HIV exposed deliveries [ Time Frame: day zero umbilical cord dried blood spot ]

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.

• Other: Neonatal resuscitation protocol
  training in neonatal resuscitation and sepsis identification early treatment
• Other: Standard of care
  continued with current standard of care for birth attendants

• Experimental: intervention
  TBAs who receive training and supplies for the intervention
  Intervention: Other: Neonatal resuscitation protocol
• Active Comparator: control
  TBAs continuing with current standard of practice
  Intervention: Other: Standard of care

• 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. Epub 2012 Apr 27.
• 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.

Inclusion Criteria:

• TBA trained in safe delivery;
• willing to sign informed consent; willing to be randomized; willing to adhere to study procedures

Exclusion Criteria:

• TBA living outside of Lufwanyama district