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Risk Related Assistance During Stabilization In Newborns At Birth

Identification And Prevention Of Risk Related Assistance During Stabilization Operations And Resuscitation In Newborns At Birth

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05023694
Enrollment
128
Registered
2021-08-26
Start date
2016-02-29
Completion date
2017-02-28
Last updated
2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn

Keywords

Newborn, adverse events, video record, resuscitation

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

Interventions

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.

OTHERVideo 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.

Sponsors

Manuel Sanchez Luna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Minutes
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* reanimation unrecorded with video * no obtained informed consent

Design outcomes

Primary

MeasureTime frameDescription
Identify number and types of adverse eventsthrough study completion, an average of 1 yearImprove safety and thus the quality of health care in the stabilization and resuscitation of the newborn in Delivery Room by identifying and preventing risks related to patient care.

Secondary

MeasureTime frameDescription
Preventive measures to limit incidentsthrough study completion, an average of 1 yearOptimize a protocol on stabilizing the newborn.
Number of income in Neonatal Unit after resuscitationthrough study completion, an average of 1 yearNICU income
Advanced reanimationsthrough study completion, an average of 1 yearNumber of advanced resuscitation

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026