Neonatal Resuscitation in Zambia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 17, 2004

Last Updated Date

April 2, 2007

Start Date ^†

October 2004

Current Primary Outcome Measures ^†

Neonatal mortality at 7 days

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00097097 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Neonatal Resuscitation in Zambia

Official Title ^†

Neonatal Resuscitation in Zambia

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^†

Asphyxia Neonatorum
Neonatal Mortality
Hypoxic Ischemic Encephalopathy

Intervention ^†

Procedure: Neonatal Resuscitation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

40000

Completion Date

November 2006

Primary Completion Date

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Zambia

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00097097

Responsible Party

Secondary IDs ^††

U01 HD043464

Study Sponsor ^†

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators ^††

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 Alternative Medicine (NCCAM)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of Alabama at Birmingham

Investigators ^†

Principal Investigator:	Waldemar A Carlo, MD	University of Alabama at Birmingham
Principal Investigator:	Elwyn Chomba, MBChB, DCH, MRCP	University Teaching Hospital, Lusaka

Information Provided By

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.