Clinical trial NCT03414671: The Effect of Standardizing the Definition of a Clinically Significant Cardiopulmonary Event on Length of Stay
Official title: The Effect of Standardizing the Definition and Approach to a Clinically Significant Cardiopulmonary Event in Infants Less Than 30 Weeks on Length of Stay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apnea of Prematurity
Keywords: apnea
Lead sponsor: Pediatrix
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 160
Sex: ALL
Minimum age (years): 23
Maximum age (years): 29
Standard ages: CHILD
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will only enroll infants admitted to the Swedish Medical Center First Hill

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.

Eligibility criteria: 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)

Primary outcomes:
measure: LOS - CSCPE
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center First Hill
state: Washington
Study officials:
affiliation: Pediatrix
name: Michael Kamitsuka, MD
role: PRINCIPAL_INVESTIGATOR
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