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Clinical Trials/NCT05023694
NCT05023694
Completed
Not Applicable

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

Manuel Sanchez Luna1 site in 1 country128 target enrollmentFebruary 2016
ConditionsInfant, Newborn

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant, Newborn
Sponsor
Manuel Sanchez Luna
Enrollment
128
Locations
1
Primary Endpoint
Identify number and types of adverse events
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
February 2017
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Manuel Sanchez Luna

Dr.

Hospital General Universitario Gregorio Marañon

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • reanimation unrecorded with video
  • no obtained informed consent

Outcomes

Primary Outcomes

Identify number and types of adverse events

Time Frame: through study completion, an average of 1 year

Improve 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 Outcomes

  • Number of income in Neonatal Unit after resuscitation(through study completion, an average of 1 year)
  • Preventive measures to limit incidents(through study completion, an average of 1 year)
  • Advanced reanimations(through study completion, an average of 1 year)

Study Sites (1)

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