Randomized Cluster Trial on Innovative and Standard Strategies for Neonatal Resuscitation Training (RCPNEOPERU Project)

NCT03210194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Neonatal Asphyxia

Interventions

BEHAVIORAL

Standard Neonatal Resuscitation Training

Theoretical and practical training on basic and advanced neonatal resuscitation skills, directed to personnel from remote health centers using Standard Training

BEHAVIORAL

MP-ICT Neonatal Resuscitation Training

Theoretical and practical training on basic and advanced neonatal resuscitation skills, directed to personnel from remote health centers using Information and Communication Technologies

Sponsors & Collaborators

  • Grand Challenges Canada

    collaborator OTHER
  • Instituto Nacional de Salud del Niño. Lima, Peru

    collaborator UNKNOWN
  • Universidad Peruana Cayetano Heredia

    lead OTHER

Principal Investigators

  • Carlos A Delgado, PhD · Universidad Nacional Mayor de San Marcos, School of Medicine, Department of Pediatrics, NEO research group; Instituto Nacional de Salud del Niño, Neonatal Unit; Universidad Peruana Cayetano Heredia, CIDIS and MAMAWAWA research centers. Lima-Peru

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-08-31
Completion
2018-09-07

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03210194 on ClinicalTrials.gov