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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
History of Changes
  Purpose

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.


Condition Intervention
Mortality
 Other: Neonatal resuscitation protocol
Other: Standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lufwanyama Neonatal Survival Project

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Sepsis
U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:
  • mortality [ Time Frame: day 28 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3559
Study Start Date: September 2006
Study Completion Date: July 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention
TBAs who receive training and supplies for the intervention
 Other: Neonatal resuscitation protocol
training in neonatal resuscitation and sepsis identification early treatment
Active Comparator: control
TBAs continuing with current standard of practice
 Other: Standard of care
continued with current standard of care for birth attendants

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518856

Sponsors and Collaborators
Boston University
Tufts University
Investigators
Principal Investigator: Christopher J Gill, MD MS Boston Universtiy
Study Director: Grace Mazala, RN Lufwanyama District Health Management Team
  More Information

No publications provided by Boston University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Davidson H. Hamer, Boston University School of Public Health
ClinicalTrials.gov Identifier: NCT00518856     History of Changes
Other Study ID Numbers: GHS-A-00-03-00020-00-4
Study First Received: August 20, 2007
Last Updated: March 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
birth asphyxia
neonatal sepsis
maternal to child transmission of HIV

ClinicalTrials.gov processed this record on May 21, 2013