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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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