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临床试验/NCT03867669
NCT03867669Unknown不适用

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

IWK Health Centre2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年4月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
Number of Participants with neurodevelopmental impairment or death

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 14 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Single Patient Room

Experimental

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

干预措施: Single patient room (Other)

Open Bay

Placebo Comparator

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

干预措施: Open Bay Unit (Other)

结局指标

主要结局

Number of Participants with neurodevelopmental impairment or death

时间窗: 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.

次要结局

  • 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 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 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)
  • Number of participants with blindness(From randomization to age 36 months corrected age)
  • Number of participants with deafness(From randomization to age 36 months corrected age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mike Vincer

Michael Vincer, Staff Neonatologist, Medical Director Perinatal Follow Up Program

IWK Health Centre

研究点 (2)

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