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Neonatal Resuscitation in Zambia

Phase 3
Not Enrolling
Asphyxia Neonatorum, Neonatal Mortality, Hypoxic Ischemic Encephalopathy

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Trial Information

Neonatal Resuscitation in Zambia

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

Inclusion 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

Type of Study:


Study Design:

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

Outcome Measure:

Neonatal mortality at 7 days

Principal Investigator

Waldemar A Carlo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Federal Government

Study ID:

GN 03



Start Date:

October 2004

Completion Date:

November 2006

Related Keywords:

  • Asphyxia Neonatorum
  • Neonatal Mortality
  • Hypoxic Ischemic Encephalopathy
  • Asphyxia
  • Neonatal mortality
  • Neonatal morbidity
  • Hypoxic ischemic encephalopathy
  • Neurodevelopmental impairment
  • Neonatal resuscitation
  • Global Network
  • Zambia
  • Africa
  • Cerebral palsy
  • Child health
  • International
  • Asphyxia
  • Asphyxia Neonatorum
  • Brain Ischemia
  • Ischemia
  • Brain Damage, Chronic
  • Delirium
  • Encephalitis
  • Hepatic Encephalopathy
  • Neurotoxicity Syndromes
  • Hypoxia-Ischemia, Brain