Neonatal Resuscitation in Zambia
Primary Purpose
Asphyxia Neonatorum, Neonatal Mortality, Hypoxic Ischemic Encephalopathy
Status
Completed
Phase
Phase 3
Locations
Zambia
Study Type
Interventional
Intervention
Neonatal Resuscitation
Sponsored by
About this trial
This is an interventional diagnostic trial for Asphyxia Neonatorum focused on measuring Asphyxia, Neonatal mortality, Neonatal morbidity, Hypoxic ischemic encephalopathy, Neurodevelopmental impairment, Neonatal resuscitation, Global Network, Zambia, Africa, Cerebral palsy, Child health, International
Eligibility Criteria
Inclusion criteria: Live birth infants with birth weight ≥ 1500 g Infants who are born at participating health centers in Lusaka and Ndola, Zambia No lethal malformations Exclusion criteria: Stillbirths Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left sided congenital heart disease that will not be repaired) Any infant who is transported/brought to the center after delivery
Sites / Locations
- University of Zambia
Outcomes
Primary Outcome Measures
Neonatal mortality at 7 days
Secondary Outcome Measures
Neonatal mortality due to perinatal asphyxia
Self efficacy, knowledge, performance, and competence in neonatal resuscitation
Apgar scores at 5 minutes
Full Information
NCT ID
NCT00097097
First Posted
November 17, 2004
Last Updated
July 29, 2014
Sponsor
NICHD Global Network for Women's and Children's Health
Collaborators
Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00097097
Brief Title
Neonatal Resuscitation in Zambia
Official Title
Neonatal Resuscitation in Zambia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NICHD Global Network for Women's and Children's Health
Collaborators
Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Asphyxia is a leading cause of neonatal death in Zambia. This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (W.H.O.) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.
Detailed Description
Birth asphyxia (defined as "failure to initiate and sustain breathing at birth") has been identified by the World Health Organization (WHO) as the most frequent cause of early deaths worldwide, accounting for about 20% of neonatal mortality. Although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from birth asphyxia, the WHO has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong. The Neonatal Resuscitation Program (NRP) has been universally accepted in the developed world but has had limited dissemination in many developing countries, including Zambia. The primary hypothesis of this study is that implementation of the combined Neonatal Resuscitation Program/WHO Essential Newborn Care (ENC) Program, compared to basic neonatal care education of health care providers (ENC only) will result in reduced neonatal 7-day mortality. This trial will be performed in two Zambian cities: Lusaka and Ndola. Training in data collection will be conducted in order to establish baseline data on mortality and asphyxia. Following this time period, all centers will receive the ENC training and continue to collect data for 7 months. The clinics will then receive NRP Training and collect data for a 12-month period.
The primary outcome will be a decrease in neonatal 7-day mortality following the NRP training when compared to the ENC-only time period. Secondary outcomes will include neonatal mortality due to perinatal asphyxia, mortality or hypoxic ischemic encephalopathy (HIE) at 7 days, need for advanced resuscitation, Apgar scores at 5 minutes, sustainability of the program, as well as providers' self efficacy, competence, and performance in neonatal resuscitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asphyxia Neonatorum, Neonatal Mortality, Hypoxic Ischemic Encephalopathy
Keywords
Asphyxia, Neonatal mortality, Neonatal morbidity, Hypoxic ischemic encephalopathy, Neurodevelopmental impairment, Neonatal resuscitation, Global Network, Zambia, Africa, Cerebral palsy, Child health, International
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Neonatal Resuscitation
Primary Outcome Measure Information:
Title
Neonatal mortality at 7 days
Secondary Outcome Measure Information:
Title
Neonatal mortality due to perinatal asphyxia
Title
Self efficacy, knowledge, performance, and competence in neonatal resuscitation
Title
Apgar scores at 5 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Live birth infants with birth weight ≥ 1500 g
Infants who are born at participating health centers in Lusaka and Ndola, Zambia
No lethal malformations
Exclusion criteria:
Stillbirths
Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left sided congenital heart disease that will not be repaired)
Any infant who is transported/brought to the center after delivery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waldemar A Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elwyn Chomba, MBChB, DCH, MRCP
Organizational Affiliation
University Teaching Hospital, Lusaka, Zambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zambia
City
Lusaka
Country
Zambia
12. IPD Sharing Statement
Links:
URL
http://gn.rti.org
Description
Global Network for Women's and Children's Health Research
URL
http://www.rti.org
Description
Research Triangle Institute International
Learn more about this trial
Neonatal Resuscitation in Zambia
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