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Neonatal Resuscitation in Zambia

Neonatal Resuscitation in Zambia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00097097
Enrollment
40000
Registered
2004-11-18
Start date
2004-10-31
Completion date
2006-11-30
Last updated
2014-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asphyxia Neonatorum, Hypoxic Ischemic Encephalopathy, Neonatal Mortality

Keywords

Asphyxia, Neonatal mortality, Neonatal morbidity, Hypoxic ischemic encephalopathy, Neurodevelopmental impairment, Neonatal resuscitation, Global Network, Zambia, Africa, Cerebral palsy, Child health, International

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.

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.

Interventions

PROCEDURENeonatal Resuscitation

Sponsors

Global Network for Women's and Children's Health Research
CollaboratorOTHER
Bill and Melinda Gates Foundation
CollaboratorOTHER
Fogarty International Center of the National Institute of Health
CollaboratorNIH
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH
RTI International
CollaboratorOTHER
University of Alabama at Birmingham
CollaboratorOTHER
NICHD Global Network for Women's and Children's Health
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Neonatal mortality at 7 days

Secondary

MeasureTime frame
Neonatal mortality due to perinatal asphyxia
Self efficacy, knowledge, performance, and competence in neonatal resuscitation
Apgar scores at 5 minutes

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026