Neonatal Asphyxia Clinical Trial
Official title:
Continuous Training and Certification in Neonatal Resuscitation in Remote Areas Using a Multi-platform Information and Communication Technology Intervention Compared to Standard Training: A Randomized Cluster Trial
Background: About 10% of all newborns may have difficulty breathing and require support by
trained personnel. In Peru, 90% of deliveries occur in health facilities; however there is
not a national neonatal resuscitation and certification program for the public health sector.
In addition, the Andes and the Amazon regions concentrate large rural remote areas, which
further limit the implementation of training programs and the accomplishment of continuous
certification. Neonatal resuscitation training through the use of information, communication
and technology (ICT) tools running on a computer, tablet or mobile phone may overcome such
limitations. This strategy allows online and offline access to educational resources, paving
the way to more frequent and efficient training and certification processes.
Objective: To evaluate the effects of a neonatal resuscitation training and certification
program that uses a multi-platform ICT (MP-ICT) strategy on neonatal health care in remote
areas.
Methods: The investigators propose to conduct the study through a cluster-randomized trial,
where the study and analysis units are the health care facility. Eligible facilities will
include primary and secondary health care level facilities that are located in provinces with
neonatal mortality rates higher than 15 per 1,000 live births. The investigators will compare
the proportion of newborns with a heart rate ≥100 beats per minute at 2 minutes after birth
in health care facilities that receive MP-ICT training and certification implementation, with
those that receive conventional training and certification.
Discussion: The investigators expect that the intervention show to be more effective than the
current standard of care. The investigators are prepared to include it within a national
neonatal resuscitation training and certification program to be implemented at national scale
together with policymakers and other key stakeholders.
Background
A training system using Multi-platform ICT (MP-ICT) tools offers reliable and easier access
to information and training packages from different locations which can be implemented even
in rural settings without access to internet. Platforms may be available online, and users
can download the training content through a personal computer, a tablet or a mobile phone.
The training content may be downloaded repeatedly afterwards, even in remote areas without
access to internet.
Our project aims to evaluate the performance of a continuous process of training and
certification in neonatal resuscitation in primary and secondary health facilities in the
departments of Ayacucho and Cusco, through the use of MP-ICT tools. It aims at providing
proof of concept of the interventions, which then could be expected to be incorporated as a
component of a national neonatal resuscitation program to be implemented nationwide.
The traditional way to train and certify health care professionals is through administration
of a theoretical expositive course, reinforced subsequently by a practical component. This
modality requires face-to-face contact between trainers and trainees. Health workers need to
move from their job site to the instruction sites, usually located in the capital city of the
department or in the capital city of the country. This poses economic and logistic challenges
to both health authorities and health workers, and results in erratic frequency and low
uptake of training courses.
Research hypothesis
The use of multi-platform ICT strategies for training and certification in neonatal
resuscitation will increase the proportion of children with heart rate equal or greater than
100/minute at two minutes of life, as compared to standard training.
Primary objective
To evaluate the effects of the use of a Multi-Platform ICT strategies for training and
certification on neonatal resuscitation in first and second level health facilities of
Ayacucho and Cusco departments.
Settings
Ayacucho and Cusco are two Peruvian regions located to the south of the country. These
regions cover areas of Andean highlands, but their territory is mainly on the Amazon
rainforest. Also, in those departments there is the "Valley of the Apurímac, Ene and Mantaro
Rivers", also known as the VRAEM, which is a geopolitical extremely poor area and one of the
major areas of coca growing in Peru.
According to Peruvian Registry of Institutions that Provide Health Services (RENIPRESS),
Ayacucho has 418 and Cusco 848 registered health facilities.
Study design
The proposed study design is a randomized cluster trial. The Units of study and analysis will
be first and second level health facilities from Ayacucho and Cusco departments. Each health
facility will be a cluster. Clusters will be randomly assigned either to the MP-ICT course
and certification package (intervention) or to the standard training and certification
package (control).
Sample size
The investigators would require 12 clusters (health facilities), divided in 6 clusters for
each one of two arms, and with an average of 334 deliveries per facility in the observation
period.
Assuming the occurrence of about 4,000 births during a period of 6 months of filed study
observation, the investigators aim at discriminating a 4% difference in the proportion of
newborns with heart rate equal or greater 100 beats per minute at 2 minutes of life between
the intervention and the control group. The proposed power of study is 80% and the acceptable
alpha error is 5%. The percentage for heart rate >100 bpm at 2 minutes of life, during
suitable resuscitation using self-inflated bag is 90% and it is the expected value for the
intervention group. For the control group it is expected at least 4 points below the value
achieved in the intervention group (i.e. no more than 86%).
Description of interventions
Standard Training
Standard training will be conducted through a theoretical-practical course, which will be
administered once during the study period, to all health professionals of the selected
facilities, according to the randomization. It is an 8-hour course, with 3 hours of theory
(based on suggested readings) and 5 hours of practice, which will take place during a single
day, approximately from 9:00 a.m. to 6:00 p.m according to the availability of the trained
instructors and participants on suitable facilities for skills training. The course will be
performed by staff of the Neonatal Unit of the Instituto Nacional de Salud del Niño (National
Institute of Child Health, Lima, Peru), and will be coordinated by an Neonatal Resuscitation
Program (NRP) instructor accredited by the American Academy of Pediatrics.
Participants who have completed their attendance to theoretical sessions, participated in the
simulated practices and approved the printed exams taken the same day will grant a Standard
Certification. The practice will be evaluated qualitatively in terms of assistance,
participation and performance of activities.
Multi-platform ICT training
The continuous process of training and certification in neonatal resuscitation will be
developed as a multi-platform format, including theory rechargeable online and accessible
offline, and will be complemented with simulated practices. The Practical Component will be
made after the Theoretical one and the activities will be completed according to the
availability of the trained instructors and participants on suitable facilities for skills
training.
The platform contains training packages, and links to review and download neonatal
resuscitation tools, technical documents, and regulatory information. During the first three
months of the project the platform is being improved and adjusted to the needs of the
fieldwork in Ayacucho and Cusco. The adaptations include increasing hosting; ameliorate
friendly usability, uploading packages and videos, improvement of examination and
certifications, and tests for readiness. The MP-ICT resource will be user-friendly and can be
accessed from remote locations through computers, personal portable devices and cell phones.
It allows downloading of the different documents, and that facilitates learning and
evaluation in an interactive and virtual way, without the physical presence of instructors or
teachers. However, through the website the investigators can generate virtual meetings as
forums or chat. In addition, the website will allow the programming of simulated practices,
with the presence of the instructor.
Authorized participants will be able to download the information for the theoretical
activities in 4 packages: Package A, B, C and D: each one containing interactive tools as
videos-360 and action mazes (as Quandary), and other videos, documents or short text to read
in Spanish. After downloading this information, the tests are enabled in sequence: When
approve part A and B, it will be enable part C and D. The interactivity is expressed in 360º
videos allowing the user to change the observation point in a recorded environment. The
interactivity for action mazes (like Quandary) has demonstrated that feedback-oriented
interactive exercises increase higher-order cognitive skills.
To be granted an MP-ICT Certification the trainee needs to have passed the online theoretical
exam, assist to the practice and approve practical skills assessment.
Randomization
Computer-generated random numbers will be used to assign the selected health facilities to
either MP-ICT training (Intervention Group) or to standard training (Control Group). There
will be a matching process of health facilities by proportion of groups of non-medical
professionals (nurses and obstetricians) and by availability of basic equipment and maternal
and newborn care supplies, to ensure that health facilities are comparable. Once paired, they
will be randomly allocated through a blocked randomization, to ensure a balanced distribution
of facilities in each group.
Effectiveness assessment
After randomization of each facility, standard training or MP-ICT training will be conducted.
Evaluations will include a baseline assessment of available equipment and supplies for
neonatal resuscitation, immediately after enrolment and before training. To determine the
duration of the effects of the intervention, the proposed outcome indicators will be
evaluated six months after the training. The primary and secondary outcomes will be assessed
intrapartum (within 5 minutes after birth) and postpartum (at 24 hours and 7 days, to know
the outcome of the infant). The assessments will be based on an observation sheet, in which
trained research assistants (registered nurses or equivalent local personnel) will record the
activities conducted during the delivery and the birth, and the results of the neonatal
resuscitation. The observation of performance in neonatal resuscitation can also be recorded
randomly through videos, to verify the validity of the data collected by the research
assistant. The videos will be reviewed by the field monitor and by one of the investigators.
In order to comply with confidentiality requirements, the videos will be deleted after
verification of information.
Statistical analysis
An intention to treat analysis will be performed, including all clusters as they were
initially assigned, including premature withdrawals. Additionally, a per-protocol analysis
will be carried out, where only clusters that have completed the study protocol will be
considered. The primary outcome will be compared in each arm using chi-square if the variable
of distribution is normal, or alternatively through the Fisher's exact test. Secondary
outcomes will be compared using the Student's t-test or the Kruskal-Wallis test, the
chi-square test or Fisher's exact test.
Staff training
The investigators will resort to local staff as research assistants including the field
supervisor. They will conduct the preparatory work and the study procedures, including
information presentations, informed consent administration, observation of case management,
and completion of case report forms. Such personnel will be trained in the conduction of
studies complying with the standards of good practice, before the study initiation.
Ethical aspects and confidentiality
The proposal, instruments and consent forms have been approved by the Ethics Committee of the
Universidad Peruana Cayetano Heredia. Written authorization will be obtained from the
authorities of the Regional Health Departments (DIRESAS) involved and from the authorities of
the health facilities. Written informed consent will be obtained from the health
professionals who will participate in the neonatal resuscitation training. Written informed
consent of the mothers will also be obtained for the collection of birth and newborn data.
The information obtained will be codified and personal identification data like names and
date of birth will be deleted to protect confidentiality. Data access will be limited to the
Principal Investigator and authorized Co-Investigators. The study documents will be stored in
locked environments at the Centro de Investigación para el Desarrollo Integral y Sostenible
(CIDIS) at Universidad Peruana Cayetano Heredia to which access will be granted only to the
Principal Investigator and the Co-Investigators authorized by the Principal Investigator.
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