Naushero Feroze Neonatal Survival Project

NCT01350765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37201

Last updated 2018-01-10

No results posted yet for this study

Summary

The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan. A team of Lady Health Workers and a Traditional Birth Attendant will provide care to the mothers and newborns at household level. A Basic Health Unit will take care of non complicated referrals and provide injectable antibiotics for neonatal sepsis. Complicated (definitions given in methods section) cases will be referred by the LHWs/BHUs to the District Headquarter Hospital which will have a functioning neonatal care unit. The District Health Services, Naushero Feroz, Provincial Department of Health, Sindh and the Federal Ministry of Health are study collaborators, therefore, guaranteeing scaling up of interventions at national level.

Hypothesis:

In comparison to a basic package of existing training program of LHWs, enhanced training of LHWs and TBAs in the early recognition and management of birth asphyxia, serious newborn infections and LBW (combined with prompt referral) will result in an additional 30% reduction in neonatal mortality.

Conditions

  • Birth Asphyxia
  • Very Low Birth Weight Baby
  • Neonatal Sepsis

Interventions

BEHAVIORAL

Intervention

The LHWs of the selected intervention areas would receive additional training on ENC for identification, management and referral for birth asphyxia, lbw and neonatal sepsis.

BEHAVIORAL

Control

The LHWs in the control areas would perform their routine tasks as assigned to them by their program

Sponsors & Collaborators

  • Save the Children

    collaborator OTHER
  • Pakistan Ministry of Health

    collaborator OTHER_GOV
  • Aga Khan University

    lead OTHER

Principal Investigators

  • Sajid B Soofi, MBBS, FCPS · Aga Khan University

  • Zulfiqar A Bhutta, PhD · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Pakistan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01350765 on ClinicalTrials.gov