Lufwanyama Neonatal Survival Project

Mortality Clinical Trial

— LUNESP  

Official title:

Lufwanyama Neonatal Survival Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518856
• Other study ID #: GHS-A-00-03-00020-00-4
• Status: Completed
• Phase: N/A
• First received: August 20, 2007
• Last updated: March 29, 2011
• Start date: September 2006
• Est. completion date: July 2009

Study information

• Verified date: March 2011
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3559
• Est. completion date: July 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mortality

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Tufts University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		day 28
Secondary	perinatal mortality		day zero
Secondary	sepsis mortality		deaths between days 1-28
Secondary	cost effectiveness		days 0-28
Secondary	successful delivery of nevirapine prophylaxis to HIV exposed deliveries		day zero umbilical cord dried blood spot