NCT06316765

Brief Summary

Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. The goal is to compare the safety and efficiency of intubations with or without a stylet.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

7 years

First QC Date

March 7, 2024

Last Update Submit

March 17, 2024

Conditions

Keywords

ResuscitationExtremely premature infantIntubationStylet

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was defined as successful initial intubation attempt.

    Successful placement of the endotracheal tube on the first intubation attempt, followed by an increase in heart rate and blood oxygen saturation.

    immediately after procedure

Secondary Outcomes (1)

  • Secondary outcomes was defined as the duration of intubation courses until successful placement of the endotracheal tube.

    immediately after procedure

Study Arms (2)

With stylet group

Intubation performed with stylet.

Procedure: Intubation with stylet

Without stylet group

Intubation performed without stylet.

Interventions

The cohort of premature infants was intubated with stylet.

With stylet group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All premature infants born at less than 30 weeks gestation between 2016 and 2022 in the General Faculty Hospital in Prague were eligible for evaluation.

You may qualify if:

  • intubation in the delivery room

You may not qualify if:

  • both method used, video record not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 18, 2024

Study Start

January 1, 2016

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 19, 2024

Record last verified: 2024-03