The Effect of Standardizing the Definition of a Clinically Significant Cardiopulmonary Event on Length of Stay
NCT ID: NCT03414671
Last Updated: 2021-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2018-06-01
2021-09-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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
No interventions assigned to this group
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)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
23 Weeks
29 Weeks
ALL
No
Sponsors
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Pediatrix
OTHER
Responsible Party
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Principal Investigators
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Michael Kamitsuka, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatrix
Locations
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Swedish Medical Center First Hill
Seattle, Washington, United States
Countries
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References
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Barrington KJ, Finer N, Li D. Predischarge respiratory recordings in very low birth weight newborn infants. J Pediatr. 1996 Dec;129(6):934-40. doi: 10.1016/s0022-3476(96)70044-6.
Cote A, Hum C, Brouillette RT, Themens M. Frequency and timing of recurrent events in infants using home cardiorespiratory monitors. J Pediatr. 1998 May;132(5):783-9. doi: 10.1016/s0022-3476(98)70304-x.
Ramanathan R, Corwin MJ, Hunt CE, Lister G, Tinsley LR, Baird T, Silvestri JM, Crowell DH, Hufford D, Martin RJ, Neuman MR, Weese-Mayer DE, Cupples LA, Peucker M, Willinger M, Keens TG; Collaborative Home Infant Monitoring Evaluation (CHIME) Study Group. Cardiorespiratory events recorded on home monitors: Comparison of healthy infants with those at increased risk for SIDS. JAMA. 2001 May 2;285(17):2199-207. doi: 10.1001/jama.285.17.2199.
Jobe AH. What do home monitors contribute to the SIDS problem? JAMA. 2001 May 2;285(17):2244-5. doi: 10.1001/jama.285.17.2244. No abstract available.
Eichenwald EC; Committee on Fetus and Newborn, American Academy of Pediatrics. Apnea of Prematurity. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-3757. Epub 2015 Dec 1.
Poets CF, Roberts RS, Schmidt B, Whyte RK, Asztalos EV, Bader D, Bairam A, Moddemann D, Peliowski A, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Investigators. Association Between Intermittent Hypoxemia or Bradycardia and Late Death or Disability in Extremely Preterm Infants. JAMA. 2015 Aug 11;314(6):595-603. doi: 10.1001/jama.2015.8841.
Poets CF, Stebbens VA, Richard D, Southall DP. Prolonged episodes of hypoxemia in preterm infants undetectable by cardiorespiratory monitors. Pediatrics. 1995 Jun;95(6):860-3.
Martin RJ, Wang K, Koroglu O, Di Fiore J, Kc P. Intermittent hypoxic episodes in preterm infants: do they matter? Neonatology. 2011;100(3):303-10. doi: 10.1159/000329922. Epub 2011 Oct 3.
Butler TJ, Firestone KS, Grow JL, Kantak AD. Standardizing documentation and the clinical approach to apnea of prematurity reduces length of stay, improves staff satisfaction, and decreases hospital cost. Jt Comm J Qual Patient Saf. 2014 Jun;40(6):263-9. doi: 10.1016/s1553-7250(14)40035-7.
Adamsons K, Myers RE. Late decelerations and brain tolerance of the fetal monkey to intrapartum asphyxia. Am J Obstet Gynecol. 1977 Aug 15;128(8):893-900. doi: 10.1016/0002-9378(77)90059-x.
Juul SE, Aylward E, Richards T, McPherson RJ, Kuratani J, Burbacher TM. Prenatal cord clamping in newborn Macaca nemestrina: a model of perinatal asphyxia. Dev Neurosci. 2007;29(4-5):311-20. doi: 10.1159/000105472.
Other Identifiers
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5892S-15
Identifier Type: -
Identifier Source: org_study_id
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