Asphyxia Neonatorum Clinical Trial
Official title:
FIRST BREATH: Neonatal Resuscitation in Developing Countries
In developing countries, neonatal death from birth asphyxia is a major problem. This study will be conducted in several countries to determine if the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to the new World Health Organization (WHO) basic perinatal care education of health care providers (Essential Newborn Care Program) results in reduced mortality due to perinatal asphyxia.
Birth asphyxia (defined as "failure to initiate and sustain breathing at birth") has been
identified by the 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. The primary
hypothesis of this randomized controlled trial 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.
The study design will include education and training of personnel at the community level and
implementation of an NRP intervention to assure validity, accuracy, and precision of the
estimate of the treatment effects. The primary hypothesis is that implementation of the NRP
educational programs will result in a decrease in neonatal mortality. The primary outcome
will be a decrease in all cause early (7 day) neonatal mortality, mortality due to any
cause, in the NRP trained communities when compared to the non-NRP trained communities.
Secondary outcomes will include early (7 day) neonatal mortality associated with perinatal
asphyxia, mortality or hypoxic ischemic encephalopathy (HIE) at 7 days, need for advanced
resuscitation, and Apgar scores at 5 minutes as well as providers' self-efficacy, knowledge,
competence, and performance in neonatal resuscitation.
This cluster randomized trial will be performed in communities of the Global Network (GN)
sites. One half of the communities will be randomized to Early Training and Intervention
with NRP; the other half will be randomized to Late Training and Intervention. Data
collection will be obtained at baseline for both groups in order to establish baseline data
including neonatal mortality and asphyxia. Following the baseline data collection period,
training of the health care providers with the WHO Integrated Management of Pregnancy and
Childbirth: Pregnancy, Postpartum, and Newborn Care Guide for Essential Practice (2003):
Essential Newborn Care Program (ENC) will be performed using a train-the-trainer system.
Following this training, communities will be randomized to Early or Late Training and
Intervention with ENC. Initially, the Early Training and Intervention sites will have a
program of train-the-trainers in NRP. Following a 12-month period of intervention (NRP vs.
control), the providers of the Late Training and Intervention sites will have training in
NRP.
Based on the early (first 7 days after birth) neonatal mortality data collected in
preparation for this protocol, we estimate that there are 25 neonatal deaths/1000 live
births. The trial is designed to identify a relative risk reduction of at least 20%
(absolute risk reduction of 5% or 5/1000 live births, from 25/1000 to 20/1000 live births)
in the treatment group as compared to the control group. The sample size necessary for the
20% relative risk reduction will be at least 32 communities with an average number of births
of >500 per year; however, we plan to randomize at least 40 communities to account for
potential drop-out. The proposed enrollment period for the randomized intervention will last
one year.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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