Neurodevelopmental Outcomes Clinical Trial
Official title:
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.
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.
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