Naushero Feroze Neonatal Survival Project

NCT01350765 | Completed DMC

• 1 other identifier: 1212-Ped/ERC
• Study Type: interventional
• Target: 37,201
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth Asphyxia; Very Low Birth Weight Baby; Neonatal Sepsis

Keywords

Birth asphyxia; Low birth weight; neonatal sepsis; mortality; community based interventions

Outcome Measures

Primary Outcomes (1)

• 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.

  two year

Secondary Outcomes (1)

• Cause specific mortality rates (due to birth asphyxia,neonatal sepsis and low birth weight)

  two years

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Intervention BEHAVIORAL

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

Control BEHAVIORAL

The LHWs in the control areas would perform their routine tasks as assigned to them by their program

Control

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Those who are not willing to participate in the study.

Sponsors & Collaborators

• Aga Khan University: lead
• Save the Children: collaborator
• Pakistan Ministry of Health: collaborator

Study Sites (1)

Pediatric Resaerch Office

Naushahro Fīroz, Sindh, Pakistan

Location

MeSH Terms

Conditions

Asphyxia Neonatorum; Neonatal Sepsis

Interventions

Methods

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sajid B Soofi, MBBS, FCPS

  Aga Khan University

  STUDY DIRECTOR

• Zulfiqar A Bhutta, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Founding Chair, Division of Women and Child Health

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 10, 2011
• Study Start: March 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)