We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Teamwork for Neonatal Resuscitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651794
First Posted: April 3, 2008
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eric Thomas, The University of Texas Health Science Center, Houston
Results First Submitted: December 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Teamwork During Neonatal Resuscitation
Interventions: Behavioral: Teamwork training
Behavioral: Standard NRP curriculum
Behavioral: Skills practice with low-fidelity mannequin
Behavioral: Skills practice with high-fidelity mannequin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All incoming interns for pediatrics, combined pediatrics and internal medicine, family medicine, emergency medicine, and obstetrics and gynecology who began training in June 2007 or June 2008 and had not previously completed NRP certification were eligible for participation in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
100 interns were consented, and 98 completed the initial megacode (that is, the initial simulation with a mannequin that was observed and scored). Baseline characteristics are reported for the 98 who completed the initial megacode.

Reporting Groups
  Description
Control (NRP Curriculum With LFT and no Team Training) Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
NRP With LFT and Team Training Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
NRP With HFT and Team Training Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators

Participant Flow:   Overall Study
    Control (NRP Curriculum With LFT and no Team Training)   NRP With LFT and Team Training   NRP With HFT and Team Training
STARTED   36   31   31 
COMPLETED   15   9   10 
NOT COMPLETED   21   22   21 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control (NRP Curriculum With LFT and no Team Training) Standard NRP curriculum with no team training; simulated resuscitation using low-fidelity simulators
NRP With LFT and Team Training Standard NRP curriculum + team training; simulated resuscitation using low-fidelity simulators
NRP With HFT and Team Training Standard NRP curriculum + team training; simulated resuscitations using high-fidelity simulators
Total Total of all reporting groups

Baseline Measures
   Control (NRP Curriculum With LFT and no Team Training)   NRP With LFT and Team Training   NRP With HFT and Team Training   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   31   31   98 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      36 100.0%      31 100.0%      31 100.0%      98 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex/Gender, Customized 
[Units: Participants]
       
Unknown   36   31   31   98 
Region of Enrollment 
[Units: Participants]
       
United States   31   31   31   93 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Teamwork Event Rate   [ Time Frame: During the megacode, which was performed about 1 hour after the training ]

2.  Secondary:   Percentage of Time Spent on Workload Management   [ Time Frame: During the megacode, which was performed about 1 hour after the training ]

3.  Secondary:   Percentage of Time Spent on Vigilance   [ Time Frame: During the megacode, which was performed about 1 hour after the training ]

4.  Secondary:   Neonatal Resuscitation Program (NRP) Quality as Assessed by NRP Performance Score   [ Time Frame: During the megacode, which was performed about 1 hour after the training ]

5.  Secondary:   Neonatal Resuscitation Program (NRP) Quality as Assessed by Resuscitation Duration   [ Time Frame: During the megacode, which was performed about 1 hour after the training ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Questions remain about whether similar training will be effective for other types of caregivers. Generalizability might be limited if other sites were not able to re-create the team training content.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Eric Thomas
Organization: University of Texas HSC-Houston
phone: 713-500-7958
e-mail: Eric.Thomas@uth.tmc.edu


Publications of Results:
Other Publications:

Responsible Party: Eric Thomas, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00651794     History of Changes
Other Study ID Numbers: UL1RR024148-01 ( U.S. NIH Grant/Contract )
First Submitted: March 31, 2008
First Posted: April 3, 2008
Results First Submitted: December 8, 2015
Results First Posted: October 19, 2017
Last Update Posted: October 19, 2017