Single Patient Room Versus Open Bay in NICU

March 6, 2019 updated by: Mike Vincer, IWK Health Centre

Neurodevelopmental Outcomes at Three Years of Age in Very Preterm Infants (< 31 Weeks Gestational Age) or Very Low Birth Weight (< 1500 Grams) Randomized to Single Patient Rooms Compared to Open Bay Neonatal Intensive Care Unit

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Do very preterm infants (< 31 weeks gestational age) and very low birth weight infants (< 1500 grams) admitted to a single patient room in the NICU have improved long-term neurodevelopmental outcomes when compared to very preterm infants admitted to an open bay in the NICU?

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Recruiting
        • IWK Health Centre
        • Contact:
        • Contact:
          • Hatfield
        • Principal Investigator:
          • Michael Vincer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All very preterm infants born less than 31 weeks gestational age or birth weight less than or equal to 1500 grams
  • age less than 14 days
  • Multiples will be randomized to the same arm.

Exclusion Criteria:

  • Babies with major anomalies
  • Babies admitted for palliative care only

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Patient Room
Patients randomized to this arm will be admitted to a NICU single patient room.
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)
Placebo Comparator: Open Bay
Patients randomized to this arm will be admitted to the open bay NICU Unit.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with neurodevelopmental impairment or death
Time Frame: From randomization to age 36 months corrected age
adverse neurodevelopmental outcome including any of the following: 1. Cerebral palsy, 2. Bayley-III scores (cognitive or language <85), 3. Blindness (vision <20/200 in the best eye) 4. Deafness (bilateral) requiring hearing aids for correction; or 5. Death prior to 36 months corrected gestational age.
From randomization to age 36 months corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with cerebral palsy
Time Frame: From randomization to age 36 months corrected age
any degree of cerebral palsy (minor = level 1 or 2) (major = level 3-5)
From randomization to age 36 months corrected age
Number of participants who died
Time Frame: From randomization to age 36 months corrected age
Death before 36 months corrected age
From randomization to age 36 months corrected age
Number of Participants with low cognitive scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)
Time Frame: From randomization to age 36 months corrected age
<85 on the Bayley Scales of Infant and Toddler Development (version III) represents -1 standard deviations below the mean. (Scale range is 55-145, higher scores are better)
From randomization to age 36 months corrected age
Number of Participants with low language scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)
Time Frame: From randomization to age 36 months corrected age
<85 on the Bayley Scales of Infant and Toddler Development (version III) which represents -1 standard deviations below the mean. (Scale range is 45-155, higher scores are better)
From randomization to age 36 months corrected age
Number of Participants with low motor scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)
Time Frame: From randomization to age 36 months corrected age
<85 on the Bayley Scales of Infant and Toddler Development (version III) which represents -1 standard deviations below the mean. (Scale range is 45-155, higher scores are better)
From randomization to age 36 months corrected age
Number of participants with blindness
Time Frame: From randomization to age 36 months corrected age
vision <20/200 in the best eye
From randomization to age 36 months corrected age
Number of participants with deafness
Time Frame: From randomization to age 36 months corrected age
Deafness (bilateral) requiring hearing aids for correction
From randomization to age 36 months corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Collaborators

Dalhousie University

Investigators

  • Principal Investigator: Michael Vincer, Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2018

Primary Completion (Anticipated)

August 31, 2019

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Single room vs open bay

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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