Lufwanyama Neonatal Survival Project (LUNESP)

Boston University

Status: Completed

Conditions: Mortality

Treatments: Other: Standard of care; Other: Neonatal resuscitation protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT00518856

GHS-A-00-03-00020-00-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,559 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,559 participants in 2 patient groups

intervention

Experimental group

Description:

TBAs who receive training and supplies for the intervention

Treatment:

Other: Neonatal resuscitation protocol

control

Active Comparator group

Description:

TBAs continuing with current standard of practice

Treatment:

Other: Standard of care