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

Completed

• Conditions: Apnea of Prematurity

• Registration Number: NCT03414671
• Lead Sponsor: Pediatrix

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Study Start: 2018-06-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-21
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LOS - CSCPE	24 months	reduce the length of stay (LOS) for premature infants after standardizing the definition and approach to a clinically significant cardiopulmonary event

Trial Locations

Locations (1)

Swedish Medical Center First Hill; 🇺🇸 Seattle, Washington, United States