NCT03210194: RCPNEOPERU

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

Completed NA Last updated 7 May 2019

What this trial tests

NA trial testing Standard Neonatal Resuscitation Training in Neonatal Asphyxia in 12 participants. Completed in 7 September 2018.

Timeline

1 April 2017

Primary endpoint
31 August 2018

7 September 2018

Quick facts

Lead sponsor	Universidad Peruana Cayetano Heredia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	12
Start date	1 April 2017
Primary completion	31 August 2018
Estimated completion	7 September 2018
Sites	1 location across Peru

Drugs / interventions tested

• Standard Neonatal Resuscitation Training
• MP-ICT Neonatal Resuscitation Training

Conditions studied

• Neonatal Asphyxia — all drugs for Neonatal Asphyxia →

Sponsor

Universidad Peruana Cayetano Heredia — full company profile →

Who can join

Eligibility, any sex, with Neonatal Asphyxia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Delgado CA, Gómez Pomar EM, Velásquez P, Sánchez V, et al · · 2017 · cited 3× · PMID 30026911 · DOI 10.12688/f1000research.12269.3
2. RCPNEOPERU trial: a cluster randomized pilot trial to assess traditional neonatal resuscitation compared to partially virtual training in remote areas.
   Delgado CA, Gómez Pomar E, Velásquez P, Sánchez V, et al · · 2025 · cited 1× · PMID 40441272 · DOI 10.1016/j.jped.2025.04.008
3. 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
   Delgado CA, Gómez Pomar EM, Velásquez P, Sánchez V, et al · · 2018 · DOI 10.12688/f1000research.12269.3