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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UNKNOWN
NA
160 participants
INTERVENTIONAL
2018-04-11
2023-03-31
Brief Summary
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Detailed Description
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Babies who will be admitted to NICU will be randomized to either the open-bay unit or single room care. The randomization will be achieved through the use of the WANNNT (Winnipeg Assessment of Neonatal Nurses Need Tool) and current patient census; this involves taking 1/3 of the fraction of the patient census on each team and adding it to 2/3 of the fraction of the WANNNT. This methodology was reviewed by several IWK Committees including Ethics, Family Leadership Council, Neonatal care Committee and the Family Centered Care Committee. This randomization is designed to ensure fairness and an equitable workload between the two units.
Eligible study infants are also enrolled in the Perinatal Follow-Up Program (PFU) as a standard of care at the IWK Health Center. The baby's legal guardian signs a consent to be enrolled in the PFU Program and to allow collection and use of data for their child as long as their child cannot be identified from the use of the data. All families of infants admitted to NICU, whether or not they have been enrolled in the PFU Program will receive an information package explaining the single patient room NICU compared with the open bay NICU.
At three years of corrected gestational age, all eligible infants will have the Bayley Scales of Infant and Toddler Development - version 3 assessment completed which evaluates cognitive, language and motor skills. These infants will also be examined for the presence or absence of cerebral palsy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Single Patient Room
Patients randomized to this arm will be admitted to a NICU single patient room.
Single patient room
The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)
Open Bay
Patients randomized to this arm will be admitted to the open bay NICU Unit.
Open Bay Unit
The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)
Interventions
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Open Bay Unit
The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)
Single patient room
The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)
Eligibility Criteria
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Inclusion Criteria
* age less than 14 days
* Multiples will be randomized to the same arm.
Exclusion Criteria
* Babies admitted for palliative care only
14 Days
ALL
No
Sponsors
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Dalhousie University
OTHER
IWK Health Centre
OTHER
Responsible Party
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Mike Vincer
Michael Vincer, Staff Neonatologist, Medical Director Perinatal Follow Up Program
Principal Investigators
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Michael Vincer
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University
Locations
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IWK Health Centre
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Hatfield
Role: backup
References
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Domanico R, Davis DK, Coleman F, Davis BO. Documenting the NICU design dilemma: comparative patient progress in open-ward and single family room units. J Perinatol. 2011 Apr;31(4):281-8. doi: 10.1038/jp.2010.120. Epub 2010 Nov 11.
Erdeve O, Arsan S, Canpolat FE, Ertem IO, Karagol BS, Atasay B, Yurdakok M, Tekinalp G, Turmen T. Does individual room implemented family-centered care contribute to mother-infant interaction in preterm deliveries necessitating neonatal intensive care unit hospitalization? Am J Perinatol. 2009 Feb;26(2):159-64. doi: 10.1055/s-0028-1095186. Epub 2008 Nov 19.
Lester BM, Hawes K, Abar B, Sullivan M, Miller R, Bigsby R, Laptook A, Salisbury A, Taub M, Lagasse LL, Padbury JF. Single-family room care and neurobehavioral and medical outcomes in preterm infants. Pediatrics. 2014 Oct;134(4):754-60. doi: 10.1542/peds.2013-4252. Epub 2014 Sep 22.
Lester BM, Salisbury AL, Hawes K, Dansereau LM, Bigsby R, Laptook A, Taub M, Lagasse LL, Vohr BR, Padbury JF. 18-Month Follow-Up of Infants Cared for in a Single-Family Room Neonatal Intensive Care Unit. J Pediatr. 2016 Oct;177:84-89. doi: 10.1016/j.jpeds.2016.06.069. Epub 2016 Jul 26.
Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25.
Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
Pineda RG, Neil J, Dierker D, Smyser CD, Wallendorf M, Kidokoro H, Reynolds LC, Walker S, Rogers C, Mathur AM, Van Essen DC, Inder T. Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments. J Pediatr. 2014 Jan;164(1):52-60.e2. doi: 10.1016/j.jpeds.2013.08.047. Epub 2013 Oct 17.
Wood-Kaczmar A, Deas E, Wood NW, Abramov AY. The role of the mitochondrial NCX in the mechanism of neurodegeneration in Parkinson's disease. Adv Exp Med Biol. 2013;961:241-9. doi: 10.1007/978-1-4614-4756-6_20.
Vohr B, McGowan E, McKinley L, Tucker R, Keszler L, Alksninis B. Differential Effects of the Single-Family Room Neonatal Intensive Care Unit on 18- to 24-Month Bayley Scores of Preterm Infants. J Pediatr. 2017 Jun;185:42-48.e1. doi: 10.1016/j.jpeds.2017.01.056. Epub 2017 Feb 24.
White RD, Smith JA, Shepley MM; Committee to Establish Recommended Standards for Newborn ICU Design. Recommended standards for newborn ICU design, eighth edition. J Perinatol. 2013 Apr;33 Suppl 1:S2-16. doi: 10.1038/jp.2013.10.
Bayley, N. (2006). Bayley Scales of Infant and Toddler Development: Technical manual (3rd ed.). San Antonio, TX: Harcourt Assessment, Inc.
Stevens, D. C., Munson, D. P., & Khan, M. A. (2016). The single-family room neonatal intensive care environment. NeoReviews, 17(12)(17(12)), e687-e696.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Winnipeg Regional Health Authority. Winnipeg Assessment of Neonatal Nurses Need Tool (WANNNT). Retrieved 01/15, 2018
Other Identifiers
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Single room vs open bay
Identifier Type: -
Identifier Source: org_study_id
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