Lufwanyama Neonatal Survival Project

NCT00518856 | Completed

• 1 other identifier: GHS-A-00-03-00020-00-4
• Study Type: interventional
• Target: 3,559
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mortality

Keywords

birth asphyxia; neonatal sepsis; maternal to child transmission of HIV

Outcome Measures

Primary Outcomes (1)

• mortality

  day 28

Secondary Outcomes (4)

• perinatal mortality

  day zero

• sepsis mortality

  deaths between days 1-28

• cost effectiveness

  days 0-28

• successful delivery of nevirapine prophylaxis to HIV exposed deliveries

  day zero umbilical cord dried blood spot

Study Arms (2)

intervention

EXPERIMENTAL

TBAs who receive training and supplies for the intervention

Other: Neonatal resuscitation protocol

control

ACTIVE COMPARATOR

TBAs continuing with current standard of practice

Other: Standard of care

Interventions

Neonatal resuscitation protocol OTHER

training in neonatal resuscitation and sepsis identification early treatment

intervention

Standard of care OTHER

continued with current standard of care for birth attendants

control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• TBA trained in safe delivery;
• willing to sign informed consent; willing to be randomized; willing to adhere to study procedures

You may not qualify if:

• TBA living outside of Lufwanyama district

Sponsors & Collaborators

• Boston University: lead
• Tufts University: collaborator

Related Publications (2)

• Gill CJ, Guerina NG, Mulenga C, Knapp AB, Mazala G, Hamer DH. Training Zambian traditional birth attendants to reduce neonatal mortality in the Lufwanyama Neonatal Survival Project (LUNESP). Int J Gynaecol Obstet. 2012 Jul;118(1):77-82. doi: 10.1016/j.ijgo.2012.02.012. Epub 2012 Apr 27.

  PMID: 22542215 DERIVED

• Gill CJ, Phiri-Mazala G, Guerina NG, Kasimba J, Mulenga C, MacLeod WB, Waitolo N, Knapp AB, Mirochnick M, Mazimba A, Fox MP, Sabin L, Seidenberg P, Simon JL, Hamer DH. Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study. BMJ. 2011 Feb 3;342:d346. doi: 10.1136/bmj.d346.

  PMID: 21292711 DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum; Neonatal Sepsis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Christopher J Gill, MD MS

  Boston Universtiy

  PRINCIPAL INVESTIGATOR

• Grace Mazala, RN

  Lufwanyama District Health Management Team

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 21, 2007
• Study Start: September 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: July 1, 2009
• Last Updated: March 31, 2011

Record last verified: 2011-03