Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network for Women's and Children's Health Research Bill and Melinda Gates Foundation John E. Fogarty International Center (FIC) National Center for Complementary and Alternative Medicine (NCCAM) National Institute of Dental and Craniofacial Research (NIDCR) National Cancer Institute (NCI) RTI International University of Alabama at Birmingham |
---|---|
Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00097097 |
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.
Condition | Intervention | Phase |
---|---|---|
Asphyxia Neonatorum Neonatal Mortality Hypoxic Ischemic Encephalopathy |
Procedure: Neonatal Resuscitation |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Neonatal Resuscitation in Zambia |
Estimated Enrollment: | 40000 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | November 2006 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Zambia | |
University of Zambia | |
Lusaka, Zambia |
Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham |
Principal Investigator: | Elwyn Chomba, MBChB, DCH, MRCP | University Teaching Hospital, Lusaka |
Study ID Numbers: | GN 03, U01 HD043464 |
Study First Received: | November 17, 2004 |
Last Updated: | April 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00097097 History of Changes |
Health Authority: | United States: Federal Government |
Asphyxia Neonatal mortality Neonatal morbidity Hypoxic ischemic encephalopathy Neurodevelopmental impairment Neonatal resuscitation |
Global Network Zambia Africa Cerebral palsy Child health International |
Asphyxia Neonatorum Death Hypoxia, Brain Vascular Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Ischemia |
Brain Diseases Cerebrovascular Disorders Paralysis Cerebral Palsy Hypoxia-Ischemia, Brain Brain Ischemia Infant, Newborn, Diseases Asphyxia |
Asphyxia Neonatorum Death Hypoxia, Brain Nervous System Diseases Vascular Diseases Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Brain Diseases Cerebrovascular Disorders Hypoxia-Ischemia, Brain Pathologic Processes Brain Ischemia Infant, Newborn, Diseases Cardiovascular Diseases Asphyxia |