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Single Patient Room Versus Open Bay in NICU

NCT03867669 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-03-08

No results posted yet for this study

Summary

The NICU at the IWK Health Center in Halifax, Nova Scotia is embarking on a redevelopment project that will see its current open bay design converted to a single room care environment. There will be a period during the redevelopment when new single room care unit will coexist with one open bay unit. This provides a unique opportunity to explore the effect of the two different environmental designs on both short and long-term outcomes. Preterm infants (under 31 weeks gestational age) and very low birth weight infants (under 1500 grams) will be randomized to either the open bay unit or the single patient room unit, at 36 months corrected age neurodevelopmental outcomes will be assessed.

Conditions

  • Neurodevelopmental Outcomes

Interventions

OTHER

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)

OTHER

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)

Sponsors & Collaborators

  • Dalhousie University

    collaborator OTHER

  • IWK Health Centre

    lead OTHER

Principal Investigators

  • Michael Vincer · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2019-08-31
Completion
2023-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867669 on ClinicalTrials.gov