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Naushero Feroze Neonatal Survival Project (AKU)

This study has been completed.
Save the Children
Pakistan Ministry of Health
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University Identifier:
First received: May 9, 2011
Last updated: July 14, 2016
Last verified: July 2016

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.


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.

Condition Intervention
Birth Asphyxia Very Low Birth Weight Baby Neonatal Sepsis Behavioral: Intervention Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Naushero Feroze Neonatal Survival Project: A Cluster Randomized Trial to Determine the Effectiveness of Package of Community Based Interventions to Reduce Neonatal Deaths Due to Birth Asphyxia, Low Birth Weight & Neonatal Sepsis

Resource links provided by NLM:

Further study details as provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:

Primary Outcome Measures:
  • neonatal mortality rate Perinatal mortality rates Neonatal mortality rates [ Time Frame: two year ]
    the subjects from the two arms would be inquired on information pertaining to socioeconomic position, health services, behaviors and morbibity/ mortality. in view of the most reported concern in the previous studies is noenatal mortality, that information will be primarily important for this research.

Secondary Outcome Measures:
  • Cause specific mortality rates (due to birth asphyxia,neonatal sepsis and low birth weight) [ Time Frame: two years ]

Enrollment: 37201
Study Start Date: March 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
This would be the interventional arm of the study, where the LHWs would receive additional training for identification and management of birth asphyxia, lbw, and sepsis.
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.
Active Comparator: Control
This would be the comparative group of the study in which the LHWs would perform the usual routine tasks assigned to them by their program.
Behavioral: Control
The LHWs in the control areas would perform their routine tasks as assigned to them by their program

  Show Detailed Description


Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Children of ages 1 day to 28 days, within the catchment area of the preformed research.

Exclusion Criteria:

Those who are not willing to participate in the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01350765

Pediatric Resaerch Office, NF campus
Naushero Feroze, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
Save the Children
Pakistan Ministry of Health
Study Director: Sajid B Soofi, MBBS, FCPS The Aga Khan University
Principal Investigator: Zulfiqar A Bhutta, PhD The Aga Khan University
  More Information

Responsible Party: Dr Zulfiqar Ahmed Bhutta, Professor and Founding Chair, Division of Women and Child Health, Aga Khan University Identifier: NCT01350765     History of Changes
Other Study ID Numbers: 1212-Ped/ERC
Study First Received: May 9, 2011
Last Updated: July 14, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:
Birth asphyxia
Low birth weight
neonatal sepsis
community based interventions

Additional relevant MeSH terms:
Asphyxia Neonatorum
Birth Weight
Systemic Inflammatory Response Syndrome
Pathologic Processes
Body Weight
Signs and Symptoms
Wounds and Injuries
Infant, Newborn, Diseases processed this record on September 21, 2017