Hypoxic Ischemic Encephalopathy Clinical Trial
Official title:
Neonatal Resuscitation in Zambia
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.
Status | Completed |
Enrollment | 40000 |
Est. completion date | November 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Zambia | University of Zambia | Lusaka |
Lead Sponsor | Collaborator |
---|---|
NICHD Global Network for Women's and Children's Health | Bill and Melinda Gates Foundation, Global Network for Women's and Children's Health Research, John E. Fogarty International Center (FIC), National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), RTI International, University of Alabama at Birmingham |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neonatal mortality at 7 days | No | ||
Secondary | Neonatal mortality due to perinatal asphyxia | |||
Secondary | Self efficacy, knowledge, performance, and competence in neonatal resuscitation | |||
Secondary | Apgar scores at 5 minutes |
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