Risk Related Assistance During Stabilization In Newborns At Birth

NCT05023694 | Completed DMC

• 1 other identifier: Neo.Segur2
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn

Keywords

Newborn; adverse events; video record; resuscitation

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Preventive measures to limit incidents

  through study completion, an average of 1 year

• Number of income in Neonatal Unit after resuscitation

  through study completion, an average of 1 year

• Advanced reanimations

  through study completion, an average of 1 year

Study Arms (1)

Newborn reanimated video recordings

Newborns, requiring stabilization at birth in Delivery Room, prior authorization by verbal and written informed consent

Other: Video recordings; Other: Video recordings after corrective measures in adverse events

Interventions

Video recordings OTHER

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.

Newborn reanimated video recordings

Video recordings after corrective measures in adverse events OTHER

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.

Newborn reanimated video recordings

Eligibility Criteria

• Age: Up to 1 Minute
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The newborns, who require stabilization at birth in delivery room

You may qualify if:

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

You may not qualify if:

• reanimation unrecorded with video
• no obtained informed consent

Sponsors & Collaborators

• Manuel Sanchez Luna: lead

Study Sites (1)

HGU Gregorio Marañón Madrid

Madrid, 28009, Spain

Location

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Gonzalo Zeballos

  Gregorio Marañón Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 23, 2016
• First Posted: August 26, 2021
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: February 1, 2017
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)