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Risk Related Assistance During Stabilization In Newborns At Birth

NCT05023694 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 128

Last updated 2021-08-26

No results posted yet for this study

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.

Conditions

  • Infant, Newborn

Interventions

OTHER

Video recordings

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.

OTHER

Video 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 & Collaborators

  • Manuel Sanchez Luna

    lead OTHER

Principal Investigators

  • Gonzalo Zeballos · Gregorio Marañón Hospital

Eligibility

Max Age
1 Minute
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-10-31
Completion
2017-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05023694 on ClinicalTrials.gov