Single Patient Room Versus Open Bay in NICU

I

IWK Health Centre

Status

Unknown

Conditions

Neurodevelopmental Outcomes

Treatments

Other: Open Bay Unit
Other: Single patient room

Study type

Interventional

Funder types

Other

Identifiers

NCT03867669
Single room vs open bay

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

Under 14 days old

Volunteers

No Healthy Volunteers

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

Trial design

160 participants in 2 patient groups, including a placebo group

Single Patient Room
Experimental group
Description:
Patients randomized to this arm will be admitted to a NICU single patient room.
Treatment:
Other: Single patient room
Open Bay
Placebo Comparator group
Description:
Patients randomized to this arm will be admitted to the open bay NICU Unit.
Treatment:
Other: Open Bay Unit

Trial documents
2

Trial contacts and locations

0

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Central trial contact

Wendy Mitchell; Tara Hatfield

Data sourced from clinicaltrials.gov

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