The Effect of Standardizing the Definition of a Clinically Significant Cardiopulmonary Event on Length of Stay (CSCPE)

October 1, 2021 updated by: Mednax Center for Research, Education, Quality and Safety

The Effect of Standardizing the Definition and Approach to a Clinically Significant Cardiopulmonary Event in Infants Less Than 30 Weeks on Length of Stay

A health care initiative will be implemented December 4, 2017 in the Newborn Intensive Care (NICU) setting in an attempt to reduce the length of stay (LOS) for premature infants after standardizing the definition and approach to a clinically significant cardiopulmonary event (CSCPE). We would like to compare LOS in infants born < 30 weeks gestation before and after standardization to see if LOS is reduced.

Study Overview

Status

Completed

Conditions

Detailed Description

The LOS of infants born < 30 weeks prior to implementation of the standardized definition of a CSCPE (11/30/2015-11/30/2017) will be compared to the LOS for all infants who meet the inclusion criteria and born < 30 weeks from 6/1/2018 - 12/31/20. Data collection will begin June 1,2018, seven months after implementing the CSCPE definition. This will allow time for the nursing staff, the physicians and nurse practitioners to become familiar with the new CSCPE definition and management.

Following implementation of the new definition, the researchers will also do a 6 month audit on nursing response to a CSCPE based on the current alarm settings. Initially we do not plan to change the alarm limits but we may find the lower alarm limits for heart rate and oxygen saturation are set too high and may need to be lowered to more accurately assist nurses in recognizing when an infant is having a CSCPE. If the 6 month audit shows nurses are "missing" a CSCPE because the current lower alarm limits are set too high, or stimulating an infant inappropriately too early, the alarm limits will be changed at every bedside. If the alarm limits are reset, data collection will begin 6 months after the alarms are changed. This is expected to be starting 1/1/2019 and conclude 12/31/20. If it is decided the lower alarm limits will not need to be changed, data collection will begin 6/1/2018 and conclude 8/31/20 instead of 12/31/20.

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center First Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will only enroll infants admitted to the Swedish Medical Center First Hill

Description

Inclusion Criteria:

  • All infants born < 30 weeks gestation admitted to the Swedish Hospital NICU from 11/30/2015-11/30/2017 (historical control, pre-standardized defined CSCPE) and 6/1/2018 - 12/31/20 (the group following implementation of the standardized defined CSCPE).

Exclusion Criteria:

  • Those babies who:
  • expired during the evaluation periods
  • transferred in after 30 weeks PMA
  • transferred out and then lost to follow-up
  • had a significant congenital, neurological, facial or airway anomaly affecting the infant's breathing beyond 36 weeks PCA
  • subjects who are not yet adults (infants, children, teenagers)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
historical control
All infants born < 30 weeks gestation admitted to the Swedish Hospital NICU from 11/30/2015-11/30/2017 (historical control, pre-standardized defined CSCPE
Standardized
All infants born < 30 weeks gestation admitted to the Swedish Hospital NICU from 6/1/2018 - 12/31/20 (the group following implementation of the standardized defined CSCPE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LOS - CSCPE
Time Frame: 24 months
reduce the length of stay (LOS) for premature infants after standardizing the definition and approach to a clinically significant cardiopulmonary event
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mednax Center for Research, Education, Quality and Safety

Investigators

  • Principal Investigator: Michael Kamitsuka, MD, Mednax Center for Research, Education, Quality and Safety

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

September 21, 2021

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 30, 2018

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5892S-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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