Risk Related Assistance During Stabilization In Newborns At Birth

NCT ID: NCT05023694

Last Updated: 2021-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-02-28

Brief Summary

Approximately 10% of term infants and up to 50% of preterm infants less than 32 weeks require stabilization and / or ventilatory support at the time of transition at birth. Coordination between the rescuer team as well as the precise knowledge of protocol resuscitation maneuvers and indications, the communication of the various professionals involved (gynecologists, pediatricians and anesthesiologists) are critical for proper care and patient stabilization. Common adverse events may hinder or impair the effectiveness of these maneuvers, ventilation, monitoring, ... with consequent worsening in the prognosis of the newborn.

Detailed Description

Patient safety is defined as reducing the risk of unnecessary harm associated with healthcare to an acceptable minimum, it is a task for all those involved in the care activity professionals, patients and managers. Since the incidents and adverse events involve a deficit in the quality of care causing damage to users and professionals, and increase healthcare costs, strategies should be to include both the detection and analysis of primary and secondary prevention.

The video recording programs are considered useful to monitor and detect problems during resuscitation and is believed to be useful for improving resuscitation.

HYPOTHESIS Principal: The mismatch in compliance with the guidelines for neonatal resuscitation is the main type of incident during resuscitation due to inadequate stabilization times . The cause of these incidents during resuscitation is varied and not only focuses on personal failure.

As a second hypothesis is that: the implementation of a protocol , after analysis of errors, minimizes by more than 15 % possible incidents and reduces the trip times.

EVALUATION Data collection will be made prospectively. Management during stabilization of the newborn in the delivery room with video is recorded by an independent contributor or fixed camera. Physiological parameters such as air pressure, gas flow , tidal volume , heart rate and oxygen saturation are monitored and recorded in the software monitor respiratory function and analog data FiO2

Conditions

Infant, Newborn

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Newborn reanimated video recordings

Newborns, requiring stabilization at birth in Delivery Room, prior authorization by verbal and written informed consent

Video recordings

Intervention Type: OTHER

In the first phase it will proceed to completion of the registration system by collecting data revivals and video recordings.

In a second phase, the video is displayed and analysis of the resuscitation performance will take place. We will identify and make a registration of incidents. At this point the observational descriptive analysis will take place.

Third phase: to develop preventive measures necessary to limit the number of incidents or to contain or minimize adverse effects resulting thereof: restructure and adapt the protocol.

Video recordings after corrective measures in adverse events

Intervention Type: OTHER

Fourth phase: Training department staff on improvements to optimize performance times protocol using simulation.

Fifth stage: final implementation of corrective measures of adverse events during the performance resuscitation.

Sixth stage: successive evaluations of impact of corrective measures. With this evaluation, it will be held another descriptive case series. With the secondary formulate hypothesis after analysis of the errors, the protocol is optimized and measured if errors are minimized: analytical observational prospective cohort study.

Interventions

Video recordings

In the first phase it will proceed to completion of the registration system by collecting data revivals and video recordings.

In a second phase, the video is displayed and analysis of the resuscitation performance will take place. We will identify and make a registration of incidents. At this point the observational descriptive analysis will take place.

Third phase: to develop preventive measures necessary to limit the number of incidents or to contain or minimize adverse effects resulting thereof: restructure and adapt the protocol.

Intervention Type: OTHER

Video recordings after corrective measures in adverse events

Fourth phase: Training department staff on improvements to optimize performance times protocol using simulation.

Fifth stage: final implementation of corrective measures of adverse events during the performance resuscitation.

Sixth stage: successive evaluations of impact of corrective measures. With this evaluation, it will be held another descriptive case series. With the secondary formulate hypothesis after analysis of the errors, the protocol is optimized and measured if errors are minimized: analytical observational prospective cohort study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• the newborns, who require stabilization at birth in delivery room

Exclusion Criteria

• reanimation unrecorded with video
• no obtained informed consent

• Maximum Eligible Age: 1 Minute
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manuel Sanchez Luna

OTHER

Sponsor Role: lead

Responsible Party

Manuel Sanchez Luna

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gonzalo Zeballos

Role: PRINCIPAL_INVESTIGATOR

Gregorio Marañón Hospital

Locations

HGU Gregorio Marañón Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

Neo.Segur2

Identifier Type: -

Identifier Source: org_study_id