Lufwanyama Neonatal Survival Project (LUNESP)

This study has been completed.
Sponsor:
Collaborator:
Tufts University
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00518856
First received: August 20, 2007
Last updated: March 29, 2011
Last verified: March 2011

August 20, 2007
March 29, 2011
September 2006
September 2008   (final data collection date for primary outcome measure)
mortality [ Time Frame: day 28 ]
Same as current
Complete list of historical versions of study NCT00518856 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lufwanyama Neonatal Survival Project
Lufwanyama Neonatal Survival Project

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Mortality
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3559
July 2009
September 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00518856
GHS-A-00-03-00020-00-4
No
Davidson H. Hamer, Boston University School of Public Health
Boston University
Tufts University
Principal Investigator: Christopher J Gill, MD MS Boston Universtiy
Study Director: Grace Mazala, RN Lufwanyama District Health Management Team
Boston University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP