Infant, NewbornNCT05023694
Risk Related Assistance During Stabilization In Newborns At Birth
An observational study of Infant, Newborn, run by Manuel Sanchez Luna at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 1 minute
- Conditions the study is for
- Infant, Newborn
- What is being tested?
- Video recordings and Video recordings after corrective measures in adverse events
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 minute
- All sexes
- No healthy volunteers
- Child
Study population: The newborns, who require stabilization at birth in delivery room
Who may be able to join
- the newborns, who require stabilization at birth in delivery room
Who cannot join
- reanimation unrecorded with video
- no obtained informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification And Prevention Of Risk Related Assistance During Stabilization Operations And Resuscitation In Newborns At Birth
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.
Read the 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
- Being tested
- Video recordings, Video recordings after corrective measures in adverse events
- Keywords
- Newborn, adverse events, video record, resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video recordingsOther
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 eventsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Newborn reanimated video recordings | Newborns, requiring stabilization at birth in Delivery Room, prior authorization by verbal and written informed consent Receives: Other: Video recordings; Other: Video recordings after corrective measures in adverse events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify number and types of adverse events
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Preventive measures to limit incidents
Optimize a protocol on stabilizing the newborn.
Measured: through study completion, an average of 1 year
Number of income in Neonatal Unit after resuscitation
NICU income
Measured: through study completion, an average of 1 year
Advanced reanimations
Number of advanced resuscitation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study startFeb 2016
- Primary completionOct 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuel Sanchez Luna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Sanchez Luna, Hospital General Universitario Gregorio Marañon
- Investigators
- Gonzalo Zeballos, Principal investigator, Gregorio Marañón Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023694
- Sponsor's protocol ID
- Neo.Segur2
- Status last verified
- Aug 2021
- First submitted
- 23 Apr 2016
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification And Prevention Of Risk Related Assistance During Stabilization Operations And Resuscitation In Newborns At Birth
- ClinicalTrials.gov ID
- NCT05023694
- Acronym / sponsor ID
- Neo.Segur2
- Conditions
- Infant, Newborn
- Keywords
- Newborn, adverse events, video record, resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Manuel Sanchez LunaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborn reanimated video recordings | – | Other: Video recordings, Other: Video recordings after corrective measures in adverse eventsNewborns, requiring stabilization at birth in Delivery Room, prior authorization by verbal and written informed consent |
Who may qualify
- Ages
- Up to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The newborns, who require stabilization at birth in delivery room
Key inclusion criteria (1 listed)
- the newborns, who require stabilization at birth in delivery room
Key exclusion criteria (2 listed)
- reanimation unrecorded with video
- no obtained informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video recordingsIn 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. | Other | Newborn reanimated video recordings |
| Video recordings after corrective measures in adverse eventsFourth 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. | Other | Newborn reanimated video recordings |
Primary outcome
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.
3 secondary outcomes
Preventive measures to limit incidents
Time frame: 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
Advanced reanimations
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonzalo Zeballos principal investigator
Gregorio Marañón Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Newborn, run by Manuel Sanchez Luna at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify number and types of adverse events (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.