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Neonatal Resuscitation in Zambia

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ClinicalTrials.gov Identifier: NCT00097097
Recruitment Status : Completed
First Posted : November 18, 2004
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asphyxia Neonatorum Neonatal Mortality Hypoxic Ischemic Encephalopathy Procedure: Neonatal Resuscitation Phase 3

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neonatal Resuscitation in Zambia
Study Start Date : October 2004
Study Completion Date : November 2006

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Neonatal mortality at 7 days

Secondary Outcome Measures :
  1. Neonatal mortality due to perinatal asphyxia
  2. Self efficacy, knowledge, performance, and competence in neonatal resuscitation
  3. Apgar scores at 5 minutes

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097097

University of Zambia
Lusaka, Zambia
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
John E. Fogarty International Center (FIC)
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of Alabama at Birmingham
Principal Investigator: Waldemar A Carlo, MD University of Alabama at Birmingham
Principal Investigator: Elwyn Chomba, MBChB, DCH, MRCP University Teaching Hospital, Lusaka, Zambia
More Information

Additional Information:
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00097097     History of Changes
Other Study ID Numbers: GN 03
U01HD043464 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2004    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by NICHD Global Network for Women's and Children's Health:
Neonatal mortality
Neonatal morbidity
Hypoxic ischemic encephalopathy
Neurodevelopmental impairment
Neonatal resuscitation
Global Network
Cerebral palsy
Child health

Additional relevant MeSH terms:
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Asphyxia Neonatorum
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases