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

Apnea of Prematurity Clinical Trial

— CSCPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414671
• Other study ID #: 5892S-15
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: September 21, 2021

Study information

• Verified date: October 2021
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 21, 2021
• Est. primary completion date: August 31, 2021
• Gender: All
• Age group: 23 Weeks to 29 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Apnea of Prematurity
• Premature Birth

Locations

Country	Name	City	State
United States	Swedish Medical Center First Hill	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety

Country where clinical trial is conducted

United States, 

References & Publications (11)

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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. — View Citation

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. — View Citation

Côté 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. — View Citation

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. — View Citation

Jobe AH. What do home monitors contribute to the SIDS problem? JAMA. 2001 May 2;285(17):2244-5. — View Citation

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. — View Citation

Martin RJ, Wang K, Köroglu 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LOS - CSCPE	reduce the length of stay (LOS) for premature infants after standardizing the definition and approach to a clinically significant cardiopulmonary event	24 months