Naushero Feroze Neonatal Survival Project (AKU)
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|ClinicalTrials.gov Identifier: NCT01350765|
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : January 10, 2018
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 or disease||Intervention/treatment||Phase|
|Birth Asphyxia Very Low Birth Weight Baby Neonatal Sepsis||Behavioral: Intervention Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37201 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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.
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.
The LHWs in the control areas would perform their routine tasks as assigned to them by their program
- 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.
- Cause specific mortality rates (due to birth asphyxia,neonatal sepsis and low birth weight) [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350765
|Pediatric Resaerch Office|
|Naushahro Fīroz, Sindh, Pakistan|
|Study Director:||Sajid B Soofi, MBBS, FCPS||The Aga Khan University|
|Principal Investigator:||Zulfiqar A Bhutta, PhD||The Aga Khan University|