NCT02572427

Brief Summary

The overall goal of this study was to create a simulation environment with repeated practice for residents and intense, immediate feedback. Repeated simulations for neonatal resuscitation when coupled with clinical experience have been shown to improve resident confidence.The investigators sought to determine if resident exposure to individual training and video laryngoscopy using the C-MAC video laryngoscope would improve cognitive skills and decrease intubation times in a neonatal manikin. The primary outcome was time to intubation after one year. The secondary outcome was the ability to retain cognitive instruction related to intubation

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 15, 2015

Completed
Last Updated

April 5, 2023

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

October 6, 2015

Results QC Date

October 9, 2015

Last Update Submit

March 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Skill in Intubating Neonatal Manikin

    Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab

    Up to two minutes

Secondary Outcomes (1)

  • Knowledge Concerning Intubation of Neonates

    30 minutes

Study Arms (2)

Education for intubation skills

EXPERIMENTAL

Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.

Other: Education for intubation skills

No added education for intubation skills

ACTIVE COMPARATOR

Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.

Other: No added education for intubation skills

Interventions

Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab.

Education for intubation skills

Routine training in neonatal resuscitation but no added experience in simulation lab.

No added education for intubation skills

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pediatric residents

You may not qualify if:

  • Residents from other departments
  • Neonatology fellows
  • Medical students
  • Medical school Faculty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Dr Richard Whit Hall
Organization
University of Arkansas for Medical Sciences

Study Officials

  • Richard W Hall, M.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 9, 2015

Study Start

September 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 5, 2023

Results First Posted

December 15, 2015

Record last verified: 2016-07