Single Patient Room Versus Open Bay in NICU

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Neurodevelopmental Outcomes

Intervention / Treatment
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* Other: Open Bay Unit
* Other: Single patient room


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Patient Room<br>Patients randomized to this arm will be admitted to a NICU single patient room. | Other: Single patient room<br>* The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)<br>|
| Placebo Comparator: Open Bay<br>Patients randomized to this arm will be admitted to the open bay NICU Unit. | Other: Open Bay Unit<br>* The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with neurodevelopmental impairment or death | 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 | 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 | 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) | <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) | <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) | <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 | vision <20/200 in the best eye | From randomization to age 36 months corrected age | 
| Number of participants with deafness | Deafness (bilateral) requiring hearing aids for correction | From randomization to age 36 months corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Developmental Disabilities, Follow-Up Studies, Infant, Premature, Intensive Care Units, Neonatal, randomized controlled trial