Naushero Feroze Neonatal Survival Project (AKU)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Aga Khan University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Save the Children
National Program for family planning and primary health care: Pakistan
Pakistan Ministry of Health
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT01350765
First received: May 9, 2011
Last updated: NA
Last verified: March 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  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 ClinicalTrials.gov identifier: NCT01350765

Contacts
Contact: Mir MK Khan, MBA, MPhil +922134864385 ext 4385 asghar.ali@aku.edu

Locations
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         
Sponsors and Collaborators
Aga Khan University
Save the Children
National Program for family planning and primary health care: Pakistan
Pakistan Ministry of Health
Investigators
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
Body Weight
Death
Infant, Newborn, Diseases
Infection
Inflammation
Pathologic Processes
Signs and Symptoms
Systemic Inflammatory Response Syndrome
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014