Clinical trial NCT05023694: Risk Related Assistance During Stabilization In Newborns At Birth
Official title: Identification And Prevention Of Risk Related Assistance During Stabilization Operations And Resuscitation In Newborns At Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Newborn
Keywords: Newborn
adverse events
video record
resuscitation
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 128
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The newborns, who require stabilization at birth in delivery room

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* reanimation unrecorded with video
* no obtained informed consent

Primary outcomes:
measure: Identify number and types of adverse events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Preventive measures to limit incidents
timeFrame: through study completion, an average of 1 year
measure: Number of income in Neonatal Unit after resuscitation
timeFrame: through study completion, an average of 1 year
measure: Advanced reanimations
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: HGU Gregorio Marañón Madrid
Study officials:
affiliation: Gregorio Marañón Hospital
name: Gonzalo Zeballos
role: PRINCIPAL_INVESTIGATOR
References: