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Completed

NCT Number: NCT00097097

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.

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Key information

Conditions

Asphyxia Neonatorum Asphyxia Brain Damage, Chronic Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Hypoxic Ischemic Encephalopathy Infant, Newborn, Diseases Neonatal Mortality Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Zambia

Lusaka, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neonatal Resuscitation

Procedure

Primary outcomes

  1. Neonatal mortality at 7 days

Secondary outcomes

  1. Neonatal mortality due to perinatal asphyxia

  2. Self efficacy, knowledge, performance, and competence in neonatal resuscitation

  3. Apgar scores at 5 minutes

Sponsors and collaborators

Lead sponsor

NICHD Global Network for Women's and Children's Health

Network

Collaborators

  • Bill and Melinda Gates Foundation
  • Fogarty International Center of the National Institute of Health
  • Global Network for Women's and Children's Health Research
  • 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

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Nov 18, 2004
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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