Recruiting

NICU Comparison

Sponsor:

IWK Health Centre

Code:

NCT03867669

Conditions

Neurodevelopmental Outcomes

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Open Bay Unit

Single patient room

Study Details

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.

Conditions

Neurodevelopmental Outcomes

Study ID

NCT03867669

Start date

Apr 11, 2018

Status verified date

Mar, 2019

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Aug 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Single Patient Room

Patients randomized to this arm will be admitted to a NICU single patient room.

placebo comparator: Open Bay

Patients randomized to this arm will be admitted to the open bay NICU Unit.

Interventions

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)

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)

Primary outcome measure

  • Number of Participants with neurodevelopmental impairment or death [ Time Frame: From randomization to age 36 months corrected age ]

Central Contacts and Locations

Central contacts

Tara Hatfield

902-470-6630tara.hatfield@iwk.nshealth.ca

Wendy Mitchell

902-470-6466wendy.mitchell@iwk.nshealth.ca

Locations

IWK Health Centre

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Tara R Hatfield

902-470-6630tara.hatfield@iwk.nshealth.ca

Principal Investigator:

Michael Vincer

More Information

Sponsor

IWK Health Centre

Last update posted

Mar 8, 2019

Last verified

Mar, 2019

Keywords

  • Developmental Disabilities
  • Follow-Up Studies
  • Infant, Premature
  • Intensive Care Units, Neonatal
  • randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2019-03-08.