Neonatal Resuscitation in Zambia

Hypoxic Ischemic Encephalopathy Clinical Trial

Official title:

Neonatal Resuscitation in Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097097
• Other study ID #: GN 03
• Secondary ID: U01HD043464
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2004
• Last updated: July 29, 2014
• Start date: October 2004
• Est. completion date: November 2006

Study information

• Verified date: July 2014
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40000
• Est. completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic Ischemic Encephalopathy
• Neonatal Mortality

Intervention

Procedure:
• Neonatal Resuscitation

Locations

Country	Name	City	State
Zambia	University of Zambia	Lusaka

Sponsors (9)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health	Bill and Melinda Gates Foundation, Global Network for Women's and Children's Health Research, John E. Fogarty International Center (FIC), 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

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal mortality at 7 days			No
Secondary	Neonatal mortality due to perinatal asphyxia
Secondary	Self efficacy, knowledge, performance, and competence in neonatal resuscitation
Secondary	Apgar scores at 5 minutes

External Links

•   Global Network for Women's and Children's Health Research
•   Research Triangle Institute International