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Trial record 20 of 84 for:    Developmental Disabilities | ( Map: Canada )

Single Patient Room Versus Open Bay in NICU

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ClinicalTrials.gov Identifier: NCT03867669
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Dalhousie University
Information provided by (Responsible Party):
Mike Vincer, IWK Health Centre

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.

Condition or disease Intervention/treatment Phase
Neurodevelopmental Outcomes Other: Open Bay Unit Other: Single patient room Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Experimental: Single Patient Room
Patients randomized to this arm will be admitted to a NICU single patient room.
Other: 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)

Placebo Comparator: Open Bay
Patients randomized to this arm will be admitted to the open bay NICU Unit.
Other: 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)




Primary Outcome Measures :
  1. Number of Participants with neurodevelopmental impairment or death [ Time Frame: 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 Outcome Measures :
  1. Number of Participants with cerebral palsy [ Time Frame: From randomization to age 36 months corrected age ]
    any degree of cerebral palsy (minor = level 1 or 2) (major = level 3-5)

  2. Number of participants who died [ Time Frame: From randomization to age 36 months corrected age ]
    Death before 36 months corrected age

  3. Number of Participants with low cognitive scores (<85) of the Bayley Scales of Infant and Toddler Development (version III) [ Time Frame: 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)

  4. Number of Participants with low language scores (<85) of the Bayley Scales of Infant and Toddler Development (version III) [ Time Frame: 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)

  5. Number of Participants with low motor scores (<85) of the Bayley Scales of Infant and Toddler Development (version III) [ Time Frame: 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)

  6. Number of participants with blindness [ Time Frame: From randomization to age 36 months corrected age ]
    vision <20/200 in the best eye

  7. Number of participants with deafness [ Time Frame: From randomization to age 36 months corrected age ]
    Deafness (bilateral) requiring hearing aids for correction



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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867669


Contacts
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Contact: Tara Hatfield 902-470-6630 tara.hatfield@iwk.nshealth.ca
Contact: Wendy Mitchell 902-470-6466 wendy.mitchell@iwk.nshealth.ca

Locations
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Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Tara R Hatfield    902-470-6630    tara.hatfield@iwk.nshealth.ca   
Contact: Hatfield         
Principal Investigator: Michael Vincer         
Sponsors and Collaborators
IWK Health Centre
Dalhousie University
Investigators
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Principal Investigator: Michael Vincer Dalhousie University
  Study Documents (Full-Text)

Documents provided by Mike Vincer, IWK Health Centre:
Informed Consent Form  [PDF] August 14, 2018


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

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Responsible Party: Mike Vincer, Michael Vincer, Staff Neonatologist, Medical Director Perinatal Follow Up Program, IWK Health Centre
ClinicalTrials.gov Identifier: NCT03867669     History of Changes
Other Study ID Numbers: Single room vs open bay
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mike Vincer, IWK Health Centre:
Developmental Disabilities
Follow-Up Studies
Infant, Premature
Intensive Care Units, Neonatal
randomized controlled trial