Neonatal Resuscitation in Zambia

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of Alabama at Birmingham
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00097097
First received: November 17, 2004
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Asphyxia Neonatorum
Neonatal Mortality
Hypoxic Ischemic Encephalopathy
Procedure: Neonatal Resuscitation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Neonatal Resuscitation in Zambia

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Neonatal mortality at 7 days [ Designated as safety issue: No ]

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

Estimated Enrollment: 40000
Study Start Date: October 2004
Study Completion Date: November 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097097

Locations
Zambia
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
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
  More Information

Additional Information:
No publications provided

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
Study First Received: November 17, 2004
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 20, 2014