Naushero Feroze Neonatal Survival Project (AKU)
Recruitment status was Recruiting
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Purpose
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.
| 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 Blind (Subject) 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 |
- neonatal mortality rate Perinatal mortality rates Neonatal mortality rates [ Time Frame: two year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16000 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | June 2012 (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 Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| 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| Contact: Mir MK Khan, MBA, MPhil | +922134864385 ext 4385 | asghar.ali@aku.edu |
| Pakistan | |
| Pediatric Resaerch Office, NF campus | Recruiting |
| Naushero Feroze, Sindh, Pakistan | |
| Contact: Shah Muhammad, MPH 92 242 481702 shah.muhammad@aku.edu | |
| Contact: Sajid B Soofi, FCPS 92 21 34864798 sajid.soofi@aku.edu | |
| Principal Investigator: Zulfiqar A Bhutta, PhD | |
| Principal Investigator: | Zulfiqar ZB Bhutta, MBBS, PhD | The Aga Khan University |
| Study Director: | Sajid SBS Soofi, MBBS, MCPS (Peds), FCPS (Peds) | The Aga Khan University |
More Information
No publications provided
| Responsible Party: | Professor Dr. Zulfiqar Ahmed Bhutta, Aga Khan University, Karachi, Pakistan |
| ClinicalTrials.gov Identifier: | NCT01350765 History of Changes |
| Other Study ID Numbers: | 1212-Ped/ERC |
| Study First Received: | May 9, 2011 |
| Last Updated: | May 9, 2011 |
| Health Authority: | National Program for family planning and primary health care: Pakistan |
Keywords provided by Aga Khan University:
|
Birth asphyxia Low birth weight neonatal sepsis mortality community based interventions |
Additional relevant MeSH terms:
|
Asphyxia Asphyxia Neonatorum Birth Weight Sepsis Toxemia Death Pathologic Processes |
Wounds and Injuries Infant, Newborn, Diseases Body Weight Signs and Symptoms Infection Systemic Inflammatory Response Syndrome Inflammation |
ClinicalTrials.gov processed this record on May 19, 2013