Naushero Feroze Neonatal Survival Project (AKU)
Primary Purpose
Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
About this trial
This is an interventional health services research trial for Birth Asphyxia focused on measuring Birth asphyxia, Low birth weight, neonatal sepsis, mortality, community based interventions
Eligibility Criteria
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.
Sites / Locations
- Pediatric Resaerch Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
neonatal mortality rate Perinatal mortality rates Neonatal mortality rates
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)
Full Information
NCT ID
NCT01350765
First Posted
May 9, 2011
Last Updated
January 9, 2018
Sponsor
Aga Khan University
Collaborators
Save the Children, Pakistan Ministry of Health
1. Study Identification
Unique Protocol Identification Number
NCT01350765
Brief Title
Naushero Feroze Neonatal Survival Project
Acronym
AKU
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 Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
Save the Children, Pakistan Ministry of Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
The proposed body of work addresses important major determinants and immediate causes of neonatal mortality in Pakistan. The recent DHS survey indicates that three causes prematurity, birth asphyxia and serious infections account for approximately 85% of the burden of newborn deaths in Pakistan (PDHS 2007). The recent evidence base of interventions for neonatal interventions clearly indicates that the investigators have a basis for action and several interventions that can make a difference to outcomes. Several of these interventions are clearly feasible within the health system and a fundamental point would be the assurance of skilled care and services for newborn resuscitation, basic preterm care and management of referred cases with neonatal infections within the health facilities (RHCs, THQ and DHQ hospitals in the catchment district). However, given the fact that the vast majority of neonatal birth and deaths still occur in community settings, the added value is the implementation of relevant interventions in community settings. To illustrate, the figure below indicates the potential interventions, links between them and pathways for reduction in the exposure to and adverse outcomes from neonatal sepsis. Although the algorithm suggests that severe neonatal infections should be referred for further care in facility settings, it is recognized that in some situations where care seeking may neither be possible nor feasible, treatment for neonatal sepsis may need to be provided at domiciliary or community level (i.e. through community based clinics or BHUs).
Research questions
Can a package of community-based interventions, linked to strengthened health facilities, reduce NMR and be feasibly delivered, with interventions focused on training TBAs & LHWs to be linked such that LHWs recognize and provide immediate/early management of the newborn complications - birth asphyxia, serious newborn infection, and low birth weight, in tandem with TBAs?
Can these community-based cadres of care providers improve and sustain skills for the provision of quality care for newborn complications of birth asphyxia, serious newborn infection, and low birth weight?
Can community-based strategies of training TBAs and LHWs, and mobilizing communities to focus on perinatal health, result in improved knowledge and use of key newborn health practices related to prevention of newborn complications such as birth asphyxia, serious newborn infections, and complications low birth weight?
Primary Objectives:
To develop and implement intervention packages for TBAs and LHWs to reduce the burden of birth asphyxia, sepsis and low birth weight and asses their feasibility for potential scale up
To assess the efficacy of this intervention package in reducing all cause neonatal mortality at population level
Secondary Objectives:
To improve case recognition and management of birth asphyxia, sepsis and LBW by primary care health care providers (in both the public and private sector such as Midwives, LHWs and TBAs) in primary care settings.
To evaluate the combined effectiveness of birth asphyxia, sepsis and low birth weight interventions delivered by TBAs and LHWs on cause specific neonatal mortality at population level.
To evaluate the effectiveness of using the enhanced intervention package to enhance collaboration and linkages between LHWs and TBAs and to increase LHW attendance during home deliveries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
Keywords
Birth asphyxia, Low birth weight, neonatal sepsis, mortality, community based interventions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
The LHWs in the control areas would perform their routine tasks as assigned to them by their program
Primary Outcome Measure Information:
Title
neonatal mortality rate Perinatal mortality rates Neonatal mortality rates
Description
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.
Time Frame
two year
Secondary Outcome Measure Information:
Title
Cause specific mortality rates (due to birth asphyxia,neonatal sepsis and low birth weight)
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sajid B Soofi, MBBS, FCPS
Organizational Affiliation
The Aga Khan University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zulfiqar A Bhutta, PhD
Organizational Affiliation
The Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Resaerch Office
City
Naushahro Fīroz
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Naushero Feroze Neonatal Survival Project
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