Clinical trial NCT00097097: Neonatal Resuscitation in Zambia
Official title: Neonatal Resuscitation in Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asphyxia Neonatorum
Neonatal Mortality
Hypoxic Ischemic Encephalopathy
Keywords: Asphyxia
Neonatal mortality
Neonatal morbidity
Hypoxic ischemic encephalopathy
Neurodevelopmental impairment
Neonatal resuscitation
Global Network
Zambia
Africa
Cerebral palsy
Child health
International
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Global Network for Women's and Children's Health Research
name: Bill and Melinda Gates Foundation
name: Fogarty International Center of the National Institute of Health
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: National Cancer Institute (NCI)
name: RTI International
name: University of Alabama at Birmingham
First posted: 2004-11-18
Enrollment: 40000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Neonatal mortality at 7 days
Secondary outcomes:
measure: Neonatal mortality due to perinatal asphyxia
measure: Self efficacy, knowledge, performance, and competence in neonatal resuscitation
measure: Apgar scores at 5 minutes
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University of Zambia
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Teaching Hospital, Lusaka, Zambia
name: Elwyn Chomba, MBChB, DCH, MRCP
role: PRINCIPAL_INVESTIGATOR
References: