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

NCT03210194 | Completed

• 1 other identifier: 100651
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Asphyxia

Keywords

Inservice Training; Neonatal Resuscitation; Randomized Cluster Trial

Outcome Measures

Primary Outcomes (1)

• Heart rate at two minutes of life

  Percentage of infants with heart rate equal or greater than 100 per minute at 2 minutes of life.

  Up to six months

Secondary Outcomes (9)

• Starting positive pressure ventilation

  Up to six months

• Heart rate >= 100 bpm

  Up to six months

• Apgar

  Up to six months

• Oxygen requirement at 10 minutes

  Up to six months

• Oxygen requirement at 30 minutes

  Up to six months

Study Arms (2)

Standard Neonatal Resuscitation Training

ACTIVE COMPARATOR

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

MP-ICT Neonatal Resuscitation Training

EXPERIMENTAL

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

Interventions

Standard Neonatal Resuscitation Training BEHAVIORAL

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

Also known as: Standard Training

Standard Neonatal Resuscitation Training

MP-ICT Neonatal Resuscitation Training BEHAVIORAL

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

Also known as: Multi-platform ICT training (MP-ICT)

MP-ICT Neonatal Resuscitation Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Grand Challenges Canada: collaborator
• Instituto Nacional de Salud del Niño. Lima, Peru: collaborator

Study Sites (1)

Instituto Nacional de Salud del Niño

Lima, 5, Peru

Location

Related Publications (12)

• Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.

  PMID: 26473001 BACKGROUND

• Lawn JE, Kerber K, Enweronu-Laryea C, Cousens S. 3.6 million neonatal deaths--what is progressing and what is not? Semin Perinatol. 2010 Dec;34(6):371-86. doi: 10.1053/j.semperi.2010.09.011.

  PMID: 21094412 BACKGROUND

• Huicho L, Canseco FD, Lema C, Miranda JJ, Lescano AG. [Incentives to attract and retain the health workforce in rural areas of Peru: a qualitative study]. Cad Saude Publica. 2012 Apr;28(4):729-39. doi: 10.1590/s0102-311x2012000400012. Spanish.

  PMID: 22488318 BACKGROUND

• Huicho L, Segura ER, Huayanay-Espinoza CA, de Guzman JN, Restrepo-Mendez MC, Tam Y, Barros AJ, Victora CG; Peru Countdown Country Case Study Working Group. Child health and nutrition in Peru within an antipoverty political agenda: a Countdown to 2015 country case study. Lancet Glob Health. 2016 Jun;4(6):e414-26. doi: 10.1016/S2214-109X(16)00085-1.

  PMID: 27198845 BACKGROUND

• Huicho L, Huayanay-Espinoza CA, Herrera-Perez E, Nino de Guzman J, Rivera-Ch M, Restrepo-Mendez MC, Barros AJ. Examining national and district-level trends in neonatal health in Peru through an equity lens: a success story driven by political will and societal advocacy. BMC Public Health. 2016 Sep 12;16 Suppl 2(Suppl 2):796. doi: 10.1186/s12889-016-3405-2.

  PMID: 27634453 BACKGROUND

• Avila J, Tavera M, Carrasco M. [Epidemiological characteristics of neonatal mortality in Peru, 2011-2012]. Rev Peru Med Exp Salud Publica. 2015 Jul-Sep;32(3):423-30. Spanish.

  PMID: 26580922 BACKGROUND

• Perlman J, Kattwinkel J, Wyllie J, Guinsburg R, Velaphi S; Nalini Singhal for the Neonatal ILCOR Task Force Group. Neonatal resuscitation: in pursuit of evidence gaps in knowledge. Resuscitation. 2012 May;83(5):545-50. doi: 10.1016/j.resuscitation.2012.01.003. Epub 2012 Jan 13.

  PMID: 22245921 BACKGROUND

• Niermeyer S. From the Neonatal Resuscitation Program to Helping Babies Breathe: Global impact of educational programs in neonatal resuscitation. Semin Fetal Neonatal Med. 2015 Oct;20(5):300-8. doi: 10.1016/j.siny.2015.06.005. Epub 2015 Aug 8.

  PMID: 26265602 BACKGROUND

• Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.

  PMID: 26477415 BACKGROUND

• Elsensohn AN, Ricks DJ, Ota A, Nevers SW, Channell N, Liaqat M, Ricks JH, Villanueva AM. The success of Peru's Neonatal Resuscitation Initiative. Arch Dis Child Fetal Neonatal Ed. 2013 Jul;98(4):F375-6. doi: 10.1136/archdischild-2013-303864. Epub 2013 May 18. No abstract available.

  PMID: 23685438 BACKGROUND

• Huicho L, Trelles M, Gonzales F, Mendoza W, Miranda J. Mortality profiles in a country facing epidemiological transition: an analysis of registered data. BMC Public Health. 2009 Feb 2;9:47. doi: 10.1186/1471-2458-9-47.

  PMID: 19187553 BACKGROUND

• Delgado CA, Gomez Pomar EM, Velasquez P, Sanchez V, Shimabuku R, Huicho L; RCPNEOPERU Study Group. 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 study protocol. F1000Res. 2017 Aug 30;6:1599. doi: 10.12688/f1000research.12269.3. eCollection 2017.

  PMID: 30026911 DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 6, 2017
• Study Start: April 1, 2017
• Primary Completion: August 31, 2018
• Study Completion: September 7, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

PE (1)