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Lufwanyama Neonatal Survival Project (LUNESP)

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ClinicalTrials.gov Identifier: NCT00518856
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : March 31, 2011
Sponsor:
Collaborator:
Tufts University
Information provided by:
Boston University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Mortality Other: Neonatal resuscitation protocol Other: Standard of care Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3559 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lufwanyama Neonatal Survival Project
Study Start Date : September 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. mortality [ Time Frame: day 28 ]

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518856


Sponsors and Collaborators
Boston University
Tufts University
Investigators
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Principal Investigator: Christopher J Gill, MD MS Boston Universtiy
Study Director: Grace Mazala, RN Lufwanyama District Health Management Team
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Davidson H. Hamer, Boston University School of Public Health
ClinicalTrials.gov Identifier: NCT00518856    
Other Study ID Numbers: GHS-A-00-03-00020-00-4
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: March 31, 2011
Last Verified: March 2011
Keywords provided by Boston University:
birth asphyxia
neonatal sepsis
maternal to child transmission of HIV