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

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ClinicalTrials.gov Identifier: NCT03210194
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
Grand Challenges Canada
Instituto Nacional de Salud del Niño. Lima, Peru
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Brief 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.


Condition or disease Intervention/treatment Phase
Neonatal Asphyxia Behavioral: Standard Neonatal Resuscitation Training Behavioral: MP-ICT Neonatal Resuscitation Training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : September 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Neonatal Resuscitation 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 and 5 hours of practice, which will take place during a single day. 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 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 we granted a Standard Certification.
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
Other Name: Standard Training

Experimental: MP-ICT Neonatal Resuscitation Training
The Multi-platform ICT (MP-ICT) training includes continuous certification in neonatal resuscitation and is being developed for online and offline access, and will be complemented with simulated practices on every site. 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 accessed from remote Peruvian locations through computers, personal portable devices and cell phones. 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.
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
Other Name: Multi-platform ICT training (MP-ICT)




Primary Outcome Measures :
  1. Heart rate at two minutes of life [ Time Frame: Up to six months ]
    Percentage of infants with heart rate equal or greater than 100 per minute at 2 minutes of life.


Secondary Outcome Measures :
  1. Starting positive pressure ventilation [ Time Frame: Up to six months ]
    Time to start positive pressure ventilation after birth

  2. Heart rate >= 100 bpm [ Time Frame: Up to six months ]
    Time to achieve heart rate greater or equal than 100 per minute

  3. Apgar [ Time Frame: Up to six months ]
    Apgar at 1 minute and at 5 minutes

  4. Oxygen requirement at 10 minutes [ Time Frame: Up to six months ]
    Use of supplemental oxygen after 10 minutes of life

  5. Oxygen requirement at 30 minutes [ Time Frame: Up to six months ]
    Inspiratory oxygen fraction needed at 30 minutes after birth

  6. Early neonatal mortality [ Time Frame: Up to six months ]
    Mortality rate during the first 7 days of life

  7. Early neonatal referral [ Time Frame: Up to six months ]
    Number of referrals to health facilities with greater resolution capacity during the first 7 days of life

  8. Certified NRP providers [ Time Frame: Up to six months ]
    Number of certified health professionals as providers

  9. Certified NRP instructors [ Time Frame: Up to six months ]
    Number of certified health professionals as instructors



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary and secondary level facilities located in Ayacucho and Cusco that have a neonatal mortality rate higher than 15 per 1,000 livebirths will be eligible

Exclusion Criteria:

  • Health facilities whose authorities refuse participation of their health professionals, facilities with less than 290 births a year, facilities located at more than 210 kilometres from the department capital and those located in high risk areas due to social unrest will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210194


Locations
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Peru
Instituto Nacional de Salud del Niño
Lima, Peru, 5
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Grand Challenges Canada
Instituto Nacional de Salud del Niño. Lima, Peru
Investigators
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Principal Investigator: 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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT03210194     History of Changes
Other Study ID Numbers: 100651
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Peruana Cayetano Heredia:
Inservice Training
Neonatal Resuscitation
Randomized Cluster Trial
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases