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

NCT03414671 | Completed DMC

• 1 other identifier: 5892S-15
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea of Prematurity

Keywords

apnea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

Eligibility Criteria

• Age: 23 Weeks - 29 Weeks
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pediatrix: lead

Study Sites (1)

Swedish Medical Center First Hill

Seattle, Washington, 98122, United States

Location

Related Publications (11)

• 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.

  PMID: 8969742 BACKGROUND

• 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.

  PMID: 9602186 BACKGROUND

• 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.

  PMID: 11325321 BACKGROUND

• 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.

  PMID: 11325327 BACKGROUND

• 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.

  PMID: 26628729 BACKGROUND

• 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.

  PMID: 26262797 BACKGROUND

• 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.

  PMID: 7761210 BACKGROUND

• 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.

  PMID: 21986336 BACKGROUND

• 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.

  PMID: 25016674 BACKGROUND

• 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.

  PMID: 407796 BACKGROUND

• 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.

  PMID: 17762199 BACKGROUND

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Kamitsuka, MD

  Pediatrix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: June 1, 2018
• Primary Completion: August 31, 2021
• Study Completion: September 21, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

US (1)