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OpenTrials
Completed

NCT Number: NCT00518856

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.

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Key information

Conditions

Mortality Asphyxia Neonatorum Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neonatal resuscitation protocol

Other

training in neonatal resuscitation and sepsis identification early treatment

Standard of care

Other

continued with current standard of care for birth attendants

Primary outcomes

  1. mortality

    Time frame: day 28

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Tufts University

Registry information

Acronym: LUNESP

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Aug 21, 2007
Registry last updated
Mar 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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