Neonatal Resuscitation in Zambia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neonatal Resuscitation in Zambia

Conditions
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Asphyxia Neonatorum, Neonatal Mortality, Hypoxic Ischemic Encephalopathy

Intervention / Treatment
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* Procedure: Neonatal Resuscitation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Neonatal Resuscitation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal mortality at 7 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal mortality due to perinatal asphyxia |  |  | 
| Self efficacy, knowledge, performance, and competence in neonatal resuscitation |  |  | 
| Apgar scores at 5 minutes |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asphyxia, Neonatal mortality, Neonatal morbidity, Hypoxic ischemic encephalopathy, Neurodevelopmental impairment, Neonatal resuscitation, Global Network, Zambia, Africa, Cerebral palsy, Child health, International