- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05023694
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Madrid, Spain, 28009
- HGU Gregorio Marañón Madrid
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- the newborns, who require stabilization at birth in delivery room
Exclusion Criteria:
- reanimation unrecorded with video
- no obtained informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Newborn reanimated video recordings
Newborns, requiring stabilization at birth in Delivery Room, prior authorization by verbal and written informed consent
|
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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preventive measures to limit incidents
Time Frame: through study completion, an average of 1 year
|
Optimize a protocol on stabilizing the newborn.
|
through study completion, an average of 1 year
|
Number of income in Neonatal Unit after resuscitation
Time Frame: through study completion, an average of 1 year
|
NICU income
|
through study completion, an average of 1 year
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Advanced reanimations
Time Frame: through study completion, an average of 1 year
|
Number of advanced resuscitation
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gonzalo Zeballos, Gregorio Marañón Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Neo.Segur2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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