NCT03867669

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

1.4 years

First QC Date

October 31, 2018

Last Update Submit

March 6, 2019

Conditions

Neurodevelopmental Outcomes

Keywords

Developmental DisabilitiesFollow-Up StudiesInfant, PrematureIntensive Care Units, Neonatalrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Number of Participants with cerebral palsy

    From randomization to age 36 months corrected age

  • Number of participants who died

    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)

    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)

    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)

    From randomization to age 36 months corrected age

  • +2 more secondary outcomes

Study Arms (2)

Single Patient Room

EXPERIMENTAL

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

Other: Single patient room

Open Bay

PLACEBO COMPARATOR

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

Other: Open Bay Unit

Interventions

Open Bay UnitOTHER

The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)

Open Bay
Single patient roomOTHER

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

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Babies with major anomalies
  • Babies admitted for palliative care only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Related Publications (12)

  • Domanico R, Davis DK, Coleman F, Davis BO. Documenting the NICU design dilemma: comparative patient progress in open-ward and single family room units. J Perinatol. 2011 Apr;31(4):281-8. doi: 10.1038/jp.2010.120. Epub 2010 Nov 11.

    PMID: 21072040BACKGROUND

  • Erdeve O, Arsan S, Canpolat FE, Ertem IO, Karagol BS, Atasay B, Yurdakok M, Tekinalp G, Turmen T. Does individual room implemented family-centered care contribute to mother-infant interaction in preterm deliveries necessitating neonatal intensive care unit hospitalization? Am J Perinatol. 2009 Feb;26(2):159-64. doi: 10.1055/s-0028-1095186. Epub 2008 Nov 19.

    PMID: 19021100BACKGROUND

  • Lester BM, Hawes K, Abar B, Sullivan M, Miller R, Bigsby R, Laptook A, Salisbury A, Taub M, Lagasse LL, Padbury JF. Single-family room care and neurobehavioral and medical outcomes in preterm infants. Pediatrics. 2014 Oct;134(4):754-60. doi: 10.1542/peds.2013-4252. Epub 2014 Sep 22.

    PMID: 25246623BACKGROUND

  • Lester BM, Salisbury AL, Hawes K, Dansereau LM, Bigsby R, Laptook A, Taub M, Lagasse LL, Vohr BR, Padbury JF. 18-Month Follow-Up of Infants Cared for in a Single-Family Room Neonatal Intensive Care Unit. J Pediatr. 2016 Oct;177:84-89. doi: 10.1016/j.jpeds.2016.06.069. Epub 2016 Jul 26.

    PMID: 27470693BACKGROUND

  • Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25.

    PMID: 20100748BACKGROUND

  • Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.

    PMID: 9183258BACKGROUND

  • Pineda RG, Neil J, Dierker D, Smyser CD, Wallendorf M, Kidokoro H, Reynolds LC, Walker S, Rogers C, Mathur AM, Van Essen DC, Inder T. Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments. J Pediatr. 2014 Jan;164(1):52-60.e2. doi: 10.1016/j.jpeds.2013.08.047. Epub 2013 Oct 17.

    PMID: 24139564BACKGROUND

  • Wood-Kaczmar A, Deas E, Wood NW, Abramov AY. The role of the mitochondrial NCX in the mechanism of neurodegeneration in Parkinson's disease. Adv Exp Med Biol. 2013;961:241-9. doi: 10.1007/978-1-4614-4756-6_20.

    PMID: 23224884BACKGROUND

  • Vohr B, McGowan E, McKinley L, Tucker R, Keszler L, Alksninis B. Differential Effects of the Single-Family Room Neonatal Intensive Care Unit on 18- to 24-Month Bayley Scores of Preterm Infants. J Pediatr. 2017 Jun;185:42-48.e1. doi: 10.1016/j.jpeds.2017.01.056. Epub 2017 Feb 24.

    PMID: 28238479BACKGROUND

  • White RD, Smith JA, Shepley MM; Committee to Establish Recommended Standards for Newborn ICU Design. Recommended standards for newborn ICU design, eighth edition. J Perinatol. 2013 Apr;33 Suppl 1:S2-16. doi: 10.1038/jp.2013.10.

    PMID: 23536026BACKGROUND

  • Bayley, N. (2006). Bayley Scales of Infant and Toddler Development: Technical manual (3rd ed.). San Antonio, TX: Harcourt Assessment, Inc.

    BACKGROUND

  • Stevens, D. C., Munson, D. P., & Khan, M. A. (2016). The single-family room neonatal intensive care environment. NeoReviews, 17(12)(17(12)), e687-e696.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Developmental DisabilitiesPremature Birth

Interventions

Patients' Rooms

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Health Facility EnvironmentHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Michael Vincer

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Hatfield

CONTACT

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

Wendy Mitchell

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michael Vincer, Staff Neonatologist, Medical Director Perinatal Follow Up Program

Study Record Dates

First Submitted

October 31, 2018

First Posted

March 8, 2019

Study Start

April 11, 2018

Primary Completion

August 31, 2019

Study Completion

March 31, 2023

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)