Neurodevelopmental Outcomes
Conditions
Keywords
Developmental Disabilities, Follow-Up Studies, Infant, Premature, Intensive Care Units, Neonatal, randomized controlled trial
Brief 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.
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.
Interventions
OTHEROpen Bay Unit
The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)
OTHERSingle 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
Dalhousie University
IWK Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with neurodevelopmental impairment or death | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who died | From randomization to age 36 months corrected age | Death before 36 months corrected age |
| Number of Participants with low cognitive scores (<85) of the Bayley Scales of Infant and Toddler Development (version III) | 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) |
| Number of Participants with low language scores (<85) of the Bayley Scales of Infant and Toddler Development (version III) | 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) |
| Number of Participants with cerebral palsy | From randomization to age 36 months corrected age | any degree of cerebral palsy (minor = level 1 or 2) (major = level 3-5) |
| Number of participants with blindness | From randomization to age 36 months corrected age | vision \<20/200 in the best eye |
| Number of participants with deafness | From randomization to age 36 months corrected age | Deafness (bilateral) requiring hearing aids for correction |
| Number of Participants with low motor scores (<85) of the Bayley Scales of Infant and Toddler Development (version III) | 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) |
Countries
Canada
Contacts
Primary ContactTara Hatfield
Backup ContactWendy Mitchell
Outcome results
None listed